Eylea patent expiration date. 154 Contents and term of patent; provisional rights.
Eylea patent expiration date. Nov 13, 2023 · We then coded all secondary patents as ancillary (claiming a drug’s physiochemical properties) or nonancillary. patent challenges. 11 / 818,463 , filed Jun . Given below is the list of those patents along with their expiration dates. Amgen will need to navigate the loss of exclusivity for Prolia/Xgeva. Dec 2, 2024 · On 2 December 2024, Formycon filed a petition for inter partes review of Regeneron’s US Patent No. Mindestens 5 Eylea-HD-Patente sind mit Eylea-Patenten identisch, was in der Regel zu einer Verlängerung des Patentablaufs führt Datum. Jul 28, 2025 · Discover the patent landcape and market exclusivity data for VABYSMO Get insights on key patent expiration dates and emerging competition. Oct 22, 2024 · Lead drug Eylea has global sales approaching $10 billion annually and is approved for wet age-related macular degeneration and other eye-related indications. AstraZeneca's diabetes portfolio will be affected by Farxiga's patent expiration. Reports are prepared on the same day. There was no terminal disclaimer filed for the ‘865 Patent, so its expiration date is in 2027. 2% after the U. Apr 3, 2023 · Eylea is a blockbuster ophthalmic drug developed by Regeneron and treats wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). 9 billion in 2017, making it one of the top selling biologicals and a lucrative target for biosimilars developers, see Table 1. Patent expiry dates for biologicals: 2016 update Biosimilars have been approved in Europe since 2006 and in the US since 2015. holds a Biologics License Application (BLA) for EYLEA®, a therapeutic product containing aflibercept, a VEGF antagonist used to treat angiogenic eye diseases. (a) IN GENERAL. A patent's expiry date may change depending upon legal activities going on that patent. 11,084,865 (previously reported Permanent Jan 29, 2025 · However, Regeneron filed a terminal disclaimer for the ‘594 Patent that produced an expiration date for this patent in 2021. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD ® (aflibercept) Injection 8 mg across all EYLEA has several programs available depending on your insurance situation to help eligible patients with the cost of EYLEA and any EYLEA patient assistance. The product patent of Eyelea, jointly developed by Regen Sep 23, 2024 · Regeneron cannot immediately block U. Doch bald laufen die Patente aus. Jul 19, 2024 · Based on these grounds, the court ultimately issued an injunction prohibiting the biosimilar companies from engaging in infringing activities such as manufacturing until patent expiration. Nov 18, 2022 · Eylea’s substance patents are scheduled to expire in June 2023 and May 2025 in the U. Feb 3, 2025 · Branded and Generic drug prices for eylea patent expiration date Oct 31, 2024 · Lead drug Eylea has global sales approaching $10 billion annually and is approved for wet age-related macular degeneration and other eye-related indications. May 24, 2023 · FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Additional patents may be granted or pending in the U. Promising candidates in its pipeline are more than enough to offset both Eylea Apr 29, 2024 · Long-term results and subgroup analyses will be presented that demonstrate durable efficacy and consistent safety of intravitreal Eylea™ 8 mg (aflibercept 8 mg) with extended treatment intervals for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) / In total, 14 accepted The report lists upcoming patent expirations, offering critical data including both generic and brand names of drugs, expiration dates, patent numbers, and the owning companies. EYLEA list of inactive ingredients, estimated key patent expiration dates, and list of generic equivalents Oct 24, 2024 · Amgen has chalked up a victory in a patent infringement lawsuit with Regeneron over blockbuster ophthalmic drug Eylea and decided to launch its biosimilar in the US – even though the legal Jan 14, 2025 · *Expiration dates are estimated and subject to change, for example, if pending patent term extension applications are granted. C. Strategies to Mitigate Patent Cliff Impact Jan 2, 2024 · A West Virginia judge ruled that Viatris' proposed biosimilar violates a Regeneron patent that covers ophthalmic formulations of Eylea, according to news reports. Mai 2025. Eylea was approved in 2011 with a patent expiration of 2023. will lean on just one of the dozens of patents behind its Eylea biologic as it seeks to block three drugmakers from selling biosimilar versions of the blockbuster Apr 18, 2025 · TARRYTOWN, N. Eylea patents are due to run out from 2023 to 2032. Patents from broad patent text search For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Feb 5, 2025 · On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Aug 3, 2018 · For patent applications filed prior to October 1, 1989, the patent expiration date is 17 years from the date of issuing. We determined the duration of added protection afforded by ancillary product patents by subtracting the ancillary product patent expiration date from the expiration date of the primary patent. Dec 16, 2022 · Some major pharma companies are preparing for expiring patents in 2023, which are expected to have a major effect on several best sellers. Dec 26, 2024 · Alteogen announced on the 26th that it has filed for patent priority on the formulation of high-dose EYLEA. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. losses of exclusivity in 2025. (REGN) Stock AMGN, REGN 5 Comments 1 Like Myriam Alvarez Mar 10, 2021 · Investors have long been concerned about the future of Bayer’s pharma franchise, given the upcoming patent cliff facing its bread and butter—heart drug Xarelto and eye med Eylea. Key Features of the Report: The report includes an exhaustive list of drug patents expiring within the specified timeframe, organized systematically for easy reference. Mar 6, 2025 · Regeneron Pharmaceuticals filed patent infringement suits against Samsung Bioepis Co. Mai 2039. Under the Biological Product Patent Transparency Act, signed into law December 27, 2020 and codified at 42 U. patent protection well into 2024, thanks to statutes offering 12-year exclusivity (for Eylea, the starting gun was its initial approval in 2011) as well as a 6-month extension for a pediatric indication and a high-dose formulation of Eylea now under study with a patent that extends through 2032. No. Jul 28, 2025 · Korean biosimilar firms pursue European market as Eylea patent nears expiration Korean companies are strategically shifting their focus to Europe amid ongoing U. dosing patents used in the retinal-disease drug Eylea, the source of more than a third of its 2021 revenue, were canceled Wednesday. patent for Eli Lilly’s pre-Ozempic GLP-1 drug Trulicity is set to expire in 2027. Approval: 2011. The Purple Book provides information on FDA-licensed biological products, including biosimilars, reference product exclusivity, and interchangeability evaluations. Specifically, within thirty (30) days after the reference Dec 28, 2023 · The statute states that “the court shall order a permanent injunction prohibiting any infringement of the patent by the biological product involved in the infringement until a date which is not earlier than the date of the expiration of the patent that has been infringed under paragraph (2) (C), provided the patent is the subject of a final Apr 23, 2025 · Eylea Patent Expiration – When Does Regulatory Exclusivity End Understand the impact of Eylea patent expiration on drug pricing and patient access to essential therapies in ophthalmology. Sep 24, 2024 · Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea. Below is an in-depth look at the drugs, their therapeutic areas, patent Feb 19, 2025 · Regeneron is already in the throes of a major patent expiry for its blockbuster eye disease drug Eylea, which in 2024 was the pharma’s top-performing asset with $5. Provisional Appli 5-40 mM of a Jan 18, 2018 · This patent was filed May 23, 2000, and has received 1,119 days of extension time under 35 USC § 156, pushing the expiration date into June 2023. —Subject to the payment of fees under this title, such grant shall be for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an Mar 10, 2021 · Its pharma division would only suffer a limited hit from the loss of exclusivity for the blood thinner medicine Xarelto and the eye treatment drug Eylea. Apr 25, 2023 · Eylea is a blockbuster ophthalmic drug developed by Regeneron and treats wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). $ 119 ( e ) of U. May 21, 2024 · The regulator on Monday approved two interchangeable biosimilars to Regeneron’s Eylea, providing additional competition for the pharma’s blockbuster as key patent protections are set to expire. 27 , 2009 , which claims the solvent ( s ) , 30-150 mM of one or more tonicity agent ( s ) , benefit under 35 U. 's YESAFILI (aflibercept-jbvf) and Samsung Bioepis, Co. Kleeh of the United States District Court for the Northern District of West Virginia issued an order finding that Mylan (Viatris) infringed claims 4, 7, 9, 11, and 14-17 of Regeneron’s U. ’s YESAFILI (aflibercept-jbvf) and Samsung Bioepis, Co. Disclaimer: The information contained in this posting does not, and is not intended to, constitute legal advice or express any opinion to be relied upon legally, for investment purposes or otherwise. Find out details of Aflibercept patent expiration, the company that first launched it, other drugs containing it as an active ingredient, and details of generic companies who have already filed for its generic Mar 9, 2021 · The company also has manufacturing, formulation, and administration regimen patents that expire at later dates. Jun 10, 2024 · The U. Several companies, including Samsung Bioepis Co. 36 billion in sales in 2020. Search by Cooperative Patent Classifications (CPCs): These are commonly used to represent ideas in place of keywords, and can also be entered in a search term box. , April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. 7,303,746; 7,303,747; and 7,306,799 expire slightly earlier due to not being extended under § 156. and Europe respectively. Aug 18, 2023 · Approval based on the pivotal PULSAR and PHOTON trials in which EYLEA ® HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer injections First and only treatment approved in wAMD and DME for immediate dosing at 8-week and up to Jan 13, 2023 · (Source) How to Calculate Patent Expiration Date Learning how to calculate patent expiration date is an important step for any R&D and innovation team. Aug 15, 2023 · Eylea’s composition of matter patent already expired in June. 6 days ago · Discover the patent landcape and market exclusivity data for EYLEA Get insights on key patent expiration dates and emerging competition. Regeneron is also involved in a few other lawsuits involving proposed Eylea biosimilars (such as Formycon AG’s and Samsung Bioepis)—both filed in November 2023. The marketing authorisation holder for this medicinal product is Bayer AG. For example, the original patent term for Regeneron was extended from May 23, 2020, to June 16, 2023. Nov 28, 2024 · The German group is racing to offset a decline in revenue as blood thinner Xarelto and eye medicine Eylea lose patent protection. Dec 31, 2023 · regn-20231231 regn-20231231 Feb 23, 2024 · This product is delivered on the very same day by e-mail containing competitor and project history reports in pdf format and database credentials. Sep 8, 2022 · Bayer said on Thursday its anti-blindness treatment Eylea, jointly developed with Regeneron , has been shown to work as well when given at a higher dose at a longer interval between injections. has been extended to May 2024, with the recent approval of pediatric exclusivity. com is accurate, up-to-date, and complete, but no guarantee is made to that effect. As we previously reported, a patent list for Regeneron’s EYLEA (aflibercept) was added to the Purple Book in April 2022. 11,084,865 (“the ’865 patent”) after a nine-day bench trial held in June 2023. Y. In 2025, Blockbuster drugs like Stelara, Eylea, and Entresto face U. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product. Such an extension would prolong the patent term for that patent to November 2025. sales of rival Amgen's proposed copy of its blockbuster eye-care drug Eylea, a federal judge in West Virginia said on Monday. 11,084,865 (previously reported Permanent Injunction Issued Preventing Launch of EYLEA ® Biosimilar Yesafili™). Sep 24, 2024 · The judge overseeing a patent infringement case denied Regeneron’s request for a temporary injunction that would have barred Amgen from immediately selling its Eylea copy, called Pavblu. A new Eylea HD patent, US11103552B2 which relates to high concentration VEGF receptor fusion protein containing formulations, has a patent expiry date of 15 May 2039. 's OPUVIZ Sep 25, 2024 · Amgen Biosimilar And EYLEA Patent Dispute: What It Means For Regeneron Investors Sep. Nov 16, 2023 · However, a single ancillary product patent extended the expiration to 2016, netting an additional 868 days of exclusivity. In response to patent owner and public inquiry, the USPTO is providing a downloadable patent term calculator as a resource to help the public estimate the expiration date of a patent. Eine höhere Dosierung könnte helfen – Studiendaten sind vielversprechend. and Biocon Biologics, Inc. Altos Biologics expects to receive approval from EMA by 2025, aligned with the substance patent expiration, and intends to negotiate License Agreements with potential distributors worldwide. Regeneron Pharmaceuticals and Bayer have developed and are marketing Eylea (aflibercept). Learn the Patent Factors in Your Country The length of Sep 24, 2024 · Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea. Apr 5, 2024 · Eylea® (aflibercept) cases Eylea® (first FDA-approved in 2011) is the youngest biologic to be subject to BPCIA litigation. The goal date set by the FDA for announcing its decision on a company’s New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date. Oct 21, 2022 · Regeneron's Eylea is already fending off competition from other medicines. Patent No. Nov 9, 2022 · Two Regeneron Pharmaceuticals Inc. It is protect by 72 US patents. appeals court ruling in its favor on Tuesday, an Amgen spokesperson said. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept. S. Ein neues Patent, US11103552B2, das sich auf hochkonzentrierte VEGF-Rezeptor-Fusionsprotein-haltige Formulierungen bezieht, hat ein Patentablaufdatum vom 15. Samsung Bioepis, Celltrion, and Biocon have filed aBLAs for their EYLEA ® biosimilar candidates SB15, CT-P42, and M710 respectively. With patents on originator biologicals expiring and ever-tightening healthcare budgets, biosimilars are expected to take an increasing share of the biologicals market. Yet, the courts are in the unique position of having to contend with scores of patents asserted within a single suit. 6 days ago · Discover the patent landcape and market exclusivity data for LUCENTIS Get insights on key patent expiration dates and biosimilar competition. exclusivity loss, opening doors for generics and biosimilars in a shifting pharma market. Patent Trial and Appeal Board ruled that a patent to treat retinal diseases was unpatenable 2 days ago · The study demonstrated therapeutic equivalence between ALT-L9 and Eylea®, prompting the submission of the Marketing Authorization Application. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®. FDA Calendar PDUFA dates and FDA Panel Review dates are very important catalysts because they are ‘make or break events’ for biotech stocks. Mar 21, 2025 · Johnson & Johnson’s Stelara, Regeneron’s Eylea and Amgen’s Prolia are just some of the drugs facing off against new biosimilars or generics in 2025, as featured in the latest edition of Feb 27, 2025 · Here's a list of 100 biologics patents expiring between 2022-2027, along with their manufacturer details, dosage, and treatments. Discover detailed patent information and market exclusivity data for EYLEA Get insights on key patent expiration dates and biosimilar competition. Sep 24, 2024 · After a federal judge blocked the entry of two biosimilars for Eylea, the same judge has rejected Regeneron's bid to block Amgen’s Eylea knockoff. FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. The CHMP adopted a new indication for the treatment of preterm infants with retinopathy of prematurity (ROP). Jul 15, 2019 · REGN's new launches have several blockbuster candidates with patent protection extending well into the 2030s. Knowing when a patent will expire can help teams plan ahead for future product development and commercialization strategies, as well as understand their rights as inventors or innovators. That's Eylea, a joint effort by Regeneron and Bayer, with $8. Product Related Patents In accordance with Section 287(a) of Title 35 of the United States Code, below is a list of certain Regeneron products and corresponding representative U. The petition closely Ser . Oct 22, 2024 · Amgen will launch its biosimilar version of Regeneron's blockbuster eye care drug Eylea following a U. The patents on Eylea will expire Eylea is a drug owned by Regeneron Pharmaceuticals, Inc. Thus, to know the drug patent expiration date one should look in for its region specifically. EYLEA HD® (aflibercept) injection, for intravitreal use Initial U. 7,608,261 on Oct. Hopefully, these approvals will end the pharmaceutical companies’ reluctance to enter this space. Regeneron sued Mylan in August 2022, claiming that a proposed copy of Eylea infringed on the “11,084,865 Apr 21, 2023 · Senator Warran recently asked what the Patent Office can do about patent thickets. Oct 5, 2023 · Bayers Augenmittel Eylea bringt dem Pharmakonzern jährlich Milliarden Euro ein. However, for patents that did not expire before July 12, 2001, the term is 17 years from the issued date or 20 years from the filing date, whichever comes later. Regeneron Pharmaceuticals, Inc. Yet, the real showdown is expected when patent expirations start to loom in the Aug 15, 2023 · Biosimilar developers have actively challenged Regeneron’s patents, with Samsung Bioepis submitting an inter partes review petition against an Eylea patent in April. On December 20, 2023, the Seoul Central District Court ruled in a preliminary injunction ("PI") action that a Korean company's activities conducted before the originator's compound patent expired under the claim of gaining product approval did not fall within the research and testing exemption allowed under the Korean Patent Act ("KPA"). [1] Several other patents, including U. Jan 11, 2024 · New York-based biotech company Regeneron has sued rival Amgen in federal court in Los Angeles, alleging that Amgen's proposed biosimilar of Regeneron's blockbuster eye drug Eylea violates its Jun 8, 1999 · Search within the title, abstract, claims, or full patent document: You can restrict your search to a specific field using field names. The calculator Patients in the Eylea groups (n=218) received Eylea 2 mg, monthly for 6 months and then received Eylea only if they met prespecified treatment criteria to Week 76 (Study GALILEO) or Week 100 (Study COPERNICUS). Mar 29, 2023 · If J&J is successful in asserting those patents, it could hamper biosimilar developers like Amgen from entering the market. , Ltd. Conclusion: Biosimilar use in ophthalmology is expected to grow with the patent expiration of two major anti–vascular endothelial growth factor drugs, ranibizumab and aflibercept, and the development of an ophthalmology-specific bevacizumab biosimilar. The calculator can be used to estimate the expiration dates of utility, plant, or design patents. In light of these facts, this paper gives estimated patent expiry dates for just some of the best Jan 19, 2024 · A new Eylea HD patent, US11103552B2 which relates to high concentration VEGF receptor fusion protein containing formulations, has a patent expiry date of 15 May 2039. Jun 16, 2023 · At least 5 Eylea HD patents are the same as Eylea patents, typically extending the patent expiry date. But here's the catch- the patent expiry depends on who you ask! 🌟 However, the plot thickens as Eylea faces fierce competition, including Novartis' Beovu. 11,084,865, which covers VEGF-trap formulations suitable for intravitreal injection. Mar 24, 2025 · In the United States, drug patents last for 20 years from the date a patent application is filed, giving the pharmaceutical company that holds the patent the ability to set the drug’s price Jan 3, 2025 · The main patent expiration is in February 2025, and several launches are expected. (SB) and four other defendants based on several patents related to Regeneron’s brand-name EYLEA® drug. Jun 8, 2022 · Patents related to Regeneron's EYLEA (aflibercept) were recently added to the Purple Book. Sep 3, 2025 · Even before the loss of patent protection, Eylea’s sales plateaued due to competition from Roche’s Vabysmo, which entered the market in early 2022 and quickly gained ground. The first commercial marketing of each, according to the biosimilar patent settlement agreement, was July 1, 2023, which would render the FIE expiration date July 1, 2024. Disclaimer Every effort has been made to ensure that the information provided by Drugslib. Jun 26, 2025 · Likewise, the dates related to patent filing and patent term expiration intertwine with actions and exclusivities related to regulatory approval as promulgated by The Hatch-Waxman Act. Pat . Jun 11, 2024 · FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron's regulatory exclusivity for EYLEA expired on May 18, 2024. Jun 7, 2022 · Patents related to Regeneron’s EYLEA (aflibercept) were recently added to the Purple Book. Regeneron reported EYLEA ® sales of $5. It is also the first biologic to be challenged prior to the expiration of its 12-year regulatory exclusivity under § 262 (k) (7) (A) of the BPCIA, which has raised issues of first impression. So, how have courts face this challenge 2 days ago · The expiration dates listed for these patents are estimates, based on the grant date of the patent. EYLEA is a blockbuster treatment for macular degeneration developed by Regeneron, which Apr 2, 2014 · SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for EYLEA and is publishing this notice of that determination as required by law. Dec 27, 2024 · The pharmaceutical industry is bracing for a transformative year as 2025 approaches, with 25 high-revenue drugs set to lose patent protection. Dec 31, 2023 · Patents asserted in other EYLEA ® biosimilar litigations but not previously against Samsung Bioepis: U. Sep 15, 2025 · Discover detailed patent information and market exclusivity data for EYLEA HD Get insights on key patent expiration dates and biosimilar competition. In China and Japan, the product loses patent protection in 2022, offering an earlier market opportunity for Alteogen. For example, J&J could use the Momenta patents as a bargaining chip to get Amgen to agree to a later market entry date than September 2023, when Stelara’s patent protection is currently expected to expire. Fool contributor Natalie Forbes owns shares of Novartis. Eylea®, a vascular endothelial growth factor inhibitor EYLEA Patent Expiration and Biosimilar Product Development Regeneron’s regulatory exclusivity period for EYLEA ended on May 17th, 2024. When do drug patents expire? Pharmaceutical business intelligence, generic launch, international patents, and more Mar 8, 2023 · Data Descriptions updated (February 24, 2017)Downloadable Data Files for the Orange Book The compressed (. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. EYLEA HD and EYLEA® (aflibercept) Injection are administered by injection into the eye. The drug was first approved by the FDA in 2014 and is used to help control blood sugar levels and help Oct 30, 2024 · 35 U. Mar 21, 2025 · Johnson & Johnson faces the largest potential loss with Stelara's expiration. Jan 29, 2025 · Regeneron Pharmaceuticals, Inc. Aflibercept (Eylea®, Zaltrap®) is a recombinant fusion protein consisting of vascular endothelial growth factor (VEGF) - binding portion from the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of a human IgG1 immunoglobulin. Regeneron and Bayer will see increased competition for Eylea. This lawsuit sounds familiar… Not surprising. In fact, Regeneron recently extended the original patent term of May 23, 2020, to June 16, 2023. Dec 29, 2023 · Armed with a new victory over Viatris in a patent dispute, Regeneron can knock off one contender in the Eylea biosimilar race. However, the expiration date of market exclusivity in the U. This will open the company up to competition from cheaper generic versions of the medicines. Eylea is expected to reach substance patent expiration in the U. Eylea had global net sales of US$5. If you're searching for seat belts, you could also search for B60R22/00 to retrieve documents Feb 1, 2024 · On December 27, 2023, Judge Thomas S. 01-5 1-100 % of mg one / ml VEGF or more - specific organic fusion co U. — ***** (2) TERM. 14 , 2007 , which issued as 35 provided protein antagonist that comprises , 0. 25, 2024 8:00 AM ET Regeneron Pharmaceuticals, Inc. ZIP) data file unzips into three files, whose field descriptions appear below. . Yet, Sandoz remains the only FDA-approved treatment (at least 4 applications are pending at FDA, and several other manufacturers have completed phase 3 trials). 11,459,374 (manufacturing), 11,505,593 (prefilled syringe), 11,793,926 (packaging). Historic genericization patterns of other small molecules reveal that post patent expiration, sales are decreasing moderately over time in Europe and in many emerging markets while in the US, the sales decline can be very pronounced. We expect a staggered impact of the loss of exclusivity for Xarelto on our top-line. This list represents a subset of Regeneron’s product patent rights. However, Regeneron filed four additional ancillary product patents that extended the patent by up to 17 years. All three Apr 22, 2021 · As the patent expiration is drawing near for the macular degeneration and diabetic macular edema therapy, Eyelea, Korean drugmakers, including Samsung Bioepis, Celltrion, Alteogen, and Samchundang Pharm, are speeding developing its biosimilars. Jan 3, 2024 · ’865 patent Expiration: June 2027 ’601 patent Expiraton: January 2032 ’572 patent Expiration: January 2032 Gotcha. Eylea patents are due to run out from 2023 to 2032; however, these should not be taken as definite dates as there are many ways drug companies can extend their patents, for example, by changing the formulation of their product. 154 Contents and term of patent; provisional rights. Amid this patent dispute and new competition, Regeneron also grapples with an FDA rejection of its high-dose Eylea due to manufacturing concerns at Catalent’s facility. When a brand pharmaceutical company shows up with 20, 60 or 100 patents in a single suit, those challenges can be exacerbated by orders of magnitude. Eylea may enjoy U. § 262 (k) (9), patents must be submitted to the FDA for listing in the Purple Book during the "Patent Dance" under the BPCIA. One new patent, US11103552B2 which relates to high concentration VEGF receptor fusion protein containing formulations, has a patent expiry date of 15 May 2039. The patent is expected to expire in June 2027. . These expirations mark significant milestones for both innovators and generics/biosimilar manufacturers, promising market disruptions and expanded access to critical therapies. (NASDAQ: REGN) today announced that the U. Apr 23, 2025 · Understand the impact of Eylea patent expiration on drug pricing and patient access to essential therapies in ophthalmology. May 2, 2024 · The biotech giant is soon to face a patent expiration for Eylea, making the high-dose formulation key to future growth. But the drug’s regulatory exclusivity remains in place until May 2024 thanks to a six-month pediatric exclusivity extension. Jan 6, 2022 · Provides a link to the Patent Register which is an alphabetical listing of medicines and the associated patents, patent expiry dates and other related information established in accordance with the Patented Medicines (Notice of Compliance) Regulations Imagine a breakthrough medicine for patients with eye conditions. Johnson & Johnson, Amgen, Regeneron, Novartis and other Big Pharma players are facing down sizable U. 97 billion in sales in the U. Nov 11, 2022 · Bayer will apply for a patent term extension for the European patent covering aflibercept, the active ingredient in Eylea, of six months once the European Commission adopts a decision for a label extension of Eylea. ’s Apr 2, 2021 · The originator product, Regeneron’s Eylea (aflibercept), was approved by the US Food and Drug Administration (FDA) in November 2011 and by the European Medicines Agency (EMA) in November 2012 [1]. DOWNLOAD free fact sheets about fusion proteins patent expiry, originators and VelaLab's analytical testing portfolio. But thanks to an pediatric exclusivity extension from the FDA, the top-selling product now has six more months of defense Is the patent expiry date the same globally? No, patent expiry is region specific. § 262 (k) (9), patents must be submitted to the FDA for listing in the Purple Book during the “Patent Dance” under the BPCIA. Regeneron has also stated intentions to try to extend the Eylea exclusivity window by filing more patent claims. Nov 9, 2022 · Regeneron (REGN) fell 1. Nov 14, 2024 · Biocon and Mylan’s Yesafili™ (aflibercept-jbvf) has been permanently enjoined from launching prior to the expiration of Regeneron’s U. Oelrich said strong demand for prostate cancer Representative Regeneron U. Jan 29, 2025 · Despite the family relationship, the ’594 patent does not share the 2027 expiration date of the ’865 patent—because Regeneron adopted a terminal disclaimer during prosecution of the ’594 patent, producing an expiration date in 2021. 72 billion in 2023. in June 2023 and in Europe in May 2025. Viatris’ Mylan unit was the first to file for an Eylea biosimilar in 2021. However, they still hold several patents, some of which may not expire until 2032. May 26, 2022 · Overall, EYLEA's impending patent cliff looks manageable, and shareholders or interested biotech investors shouldn't be too worried. Dr. Looking out over the next decade, some of the biggest drugs in the industry will tumble off the patent cliff, putting pharma giants in the hot seat as investors clamor for their next blockbuster. Apr 4, 2018 · The United States Patent and Trademark Office does not calculate expiration dates for patents. In the case of Regeneron, the approval extends the patent expiration date of Eylea by 6 months due to the pediatric exclusivity extension. (SB), filed abbreviated Patent Expiries 2025-2030 Expected generic entries by indication area in the next years on the pharmaceutical market Germany Generic entry after expiration patent / SPC / data protection For several ATC codes, only 1 entry was counted per active ingredient (combination), only the first expiry for several SPCs On 10 November 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Eylea. Oct 29, 2021 · Berlin, October 29, 2021 - The European Patent Office has reversed a first instance decision and maintained a Bayer patent (EP 1 845 961) on the once-daily administration of rivaroxaban (Xarelto™; 10, 15 and 20 mg). Nov 15, 2024 · Biocon and Mylan’s Yesafili™ (aflibercept-jbvf) has been permanently enjoined from launching prior to the expiration of Regeneron’s U. The drug patent may expire in different year in US and in different year in India. Together with the glycosylation pattern of the FC-part, its molecular weight is 115 kDa. Regeneron also owns U. and in other Sep 1, 2020 · The Orange Book provides details about an approved drug product, including the patents covering the approved drug product and the expiration dates of the patents and regulatory exclusivities, leaving investors, competitors, and the public in the dark as to when an approved biological product falls into the public domain. Patent Nos. patents associated with the relevant product. Jul 31, 2024 · Regeneron dismissed EYLEA patent IPR appeals 23-1395 and 23-1396 by Mylan, Celltrion, and Apotex, and requested adverse judgment in IPR2023-00884 by Samsung BIoepis. Jan 11, 2024 · Thus, 18 months from approval would result in expiration of FIE on April 15, 2023, and on September 18, 2023 respectively. 2 days ago · The expiration dates listed for these patents are estimates, based on the grant date of the patent. Jun 16, 2023 · Eylea and Eylea HD patents are due to run out from 2023 to 2039; however, these should not be taken as definite dates as there are many ways drug companies can extend their patents, for example, by changing the formulation of their product. Specifically, within thirty (30) days after the reference Aug 30, 2023 · For instance, Alteogen filed an international patent cooperation treaty (PCT) application for the PFS formulation (made of plastic) of 'ALT-L9', a biosimilar candidate for aflibercept [10]. hvxti fcclpbl aiaqf tfu abkt sixjo ncjup osme uwfic gwmd