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Author: Admin | 2025-04-28
Coverage. 4 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 Pradaxa. 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: Pradaxa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 20, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application) Pradaxa Generic API suppliers: Dabigatran Etexilate Mesylate is the generic name for the brand Pradaxa. 8 different companies have already filed for the generic of Pradaxa, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pradaxa's generic How can I launch a generic of Pradaxa before its drug patent expiration? : You can seek FDA approval to launch a generic drug before the expiration of Pradaxa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pradaxa'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 Pradaxa - Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status eq. to 75 mg base and 150 mg base 20 Oct, 2014 17 06 May, 2020 31 Aug, 2027 Eligibleeq. to 110 mg base 15 Dec, 2015 2 20 Jan, 2031 About Pradaxa Pradaxa is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for preventing and treating blood clots. Pradaxa uses Dabigatran Etexilate Mesylate as an active ingredient. Pradaxa was launched by Boehringer Ingelheim in 2010. Pradaxa
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