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Author: Admin | 2025-04-28
Granted and Under Opposition EP10016112A Jan, 2020 Instone, Terry/Appleyard Lees IP LLP/Read, Howard Granted and Under Opposition EP15181545A Sep, 2018 Generics (U.K.) Limited Granted and Under Opposition EP11180259A Nov, 2015 Teva Pharmaceutical Industries Ltd. Opposition rejected EP11180259A Nov, 2015 PHARMATHEN S.A. Opposition rejected EP06801867A Sep, 2015 COOLEY LLP Revoked EP06801867A Sep, 2015 Generics [UK] Ltd (trading as Mylan) Revoked EP06801867A Sep, 2015 Teva Pharmaceutical Industries Ltd. Revoked EP06801867A Sep, 2015 Glaxo Group Limited Revoked EP06801867A Sep, 2015 PENTAFARMA, Sociedade Técnico-Medicinal, SA Revoked EP06801867A Aug, 2015 PHARMATHEN S.A. Revoked EP07784499A Apr, 2015 LEK Pharmaceuticals d.d. Patent maintained as amended US patents provide insights into the exclusivity only within the United States, but Farxiga is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Farxiga's family patents as well as insights into ongoing legal events on those patents. Farxiga's Family Patents Farxiga has patent protection in a total of 51 countries. It's US patent count contributes only to 17.8% of its total global patent coverage. 8 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Farxiga. Explore Our Curated Drug Screens Drugs Generating Over $1 Billion in Annual Revenue Explore the top-performing drugs that dominate the pharmaceutical industry View ListNCE-1 Patent Expiry in the Next 1 Year Identify opportunities as new chemical entity (NCE-1) patents approach expiry View ListRecently Granted Patents in EP Find the opportunity to file Oppositions View List Generic Launch Generic Release Date: Farxiga's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 09, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application) How can I launch a generic of Farxiga before its drug patent expiration? : You can seek FDA approval to launch a generic drug before the expiration of Farxiga's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Farxiga's sponsor is invalid, unenforceable, or will not be infringed by your generic product. Given below are the details of the already filed Para IV certificates on Farxiga - Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status 5 mg and 10 mg 08 Jan, 2018 20 22 Feb, 2022 26 May, 2030 Deferred Alternative Brands for Farxiga
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