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Last Updated: September 19, 2020

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COUMADIN Drug Profile

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When do Coumadin patents expire, and when can generic versions of Coumadin launch?

Coumadin is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in COUMADIN is warfarin sodium. There are twenty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Coumadin

A generic version of COUMADIN was approved as warfarin sodium by BARR on March 26th, 1997.

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Drug patent expirations by year for COUMADIN
Drug Prices for COUMADIN

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Drug Sales Revenue Trends for COUMADIN

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Recent Clinical Trials for COUMADIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yantai Yuhuangding HospitalPhase 3
Anhui Provincial HospitalPhase 3
Shanghai Zhongshan HospitalPhase 3

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Pharmacology for COUMADIN
Drug ClassVitamin K Antagonist
Mechanism of ActionVitamin K Inhibitors

US Patents and Regulatory Information for COUMADIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb COUMADIN warfarin sodium INJECTABLE;INJECTION 009218-024 Feb 7, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb COUMADIN warfarin sodium TABLET;ORAL 009218-025 Nov 18, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb COUMADIN warfarin sodium TABLET;ORAL 009218-022 Mar 1, 1990 AB RX Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb COUMADIN warfarin sodium TABLET;ORAL 009218-005 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb COUMADIN warfarin sodium TABLET;ORAL 009218-023 Aug 24, 1993 AB RX Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb COUMADIN warfarin sodium INJECTABLE;INJECTION 009218-020 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb COUMADIN warfarin sodium INJECTABLE;INJECTION 009218-012 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Express Scripts
Moodys
Dow
Colorcon

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