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Last Updated: March 19, 2024

Warfarin sodium - Generic Drug Details


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What are the generic drug sources for warfarin sodium and what is the scope of freedom to operate?

Warfarin sodium is the generic ingredient in five branded drugs marketed by Bristol Myers Squibb, Pharm Res Assoc, Upsher Smith Labs, Abbott, Amneal Pharms, Aurobindo Pharma Usa, Barr, Chartwell Rx, Invagen Pharms, Ipca Labs Ltd, Pliva, Taro, Usl Pharma, Watson Labs, and Zydus Pharms Usa, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for warfarin sodium. Twenty-four suppliers are listed for this compound.

Drug Prices for warfarin sodium

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Drug Sales Revenue Trends for warfarin sodium

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Recent Clinical Trials for warfarin sodium

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

SponsorPhase
AmgenEarly Phase 1
Boehringer IngelheimN/A
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Phase 1

See all warfarin sodium clinical trials

Pharmacology for warfarin sodium
Drug ClassVitamin K Antagonist
Mechanism of ActionVitamin K Inhibitors

US Patents and Regulatory Information for warfarin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx WARFARIN SODIUM warfarin sodium TABLET;ORAL 040196-005 Sep 30, 1997 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro WARFARIN SODIUM warfarin sodium TABLET;ORAL 040301-003 Jul 15, 1999 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms Usa WARFARIN SODIUM warfarin sodium TABLET;ORAL 040663-005 May 30, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro WARFARIN SODIUM warfarin sodium TABLET;ORAL 040301-007 Jul 15, 1999 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs WARFARIN SODIUM warfarin sodium TABLET;ORAL 086120-001 Aug 17, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Usa WARFARIN SODIUM warfarin sodium TABLET;ORAL 040415-002 Sep 27, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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