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Last Updated: March 28, 2024

Rofecoxib - Generic Drug Details


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What are the generic sources for rofecoxib and what is the scope of freedom to operate?

Rofecoxib is the generic ingredient in one branded drug marketed by Merck and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for rofecoxib.

Recent Clinical Trials for rofecoxib

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

SponsorPhase
Tremeau Pharmceuticals, Inc.Phase 3
National Heart, Lung, and Blood Institute (NHLBI)Phase 1
University of PennsylvaniaPhase 1

See all rofecoxib clinical trials

US Patents and Regulatory Information for rofecoxib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck VIOXX rofecoxib TABLET;ORAL 021042-001 May 20, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib SUSPENSION;ORAL 021052-002 May 20, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib TABLET;ORAL 021042-003 Feb 25, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib TABLET;ORAL 021042-002 May 20, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib SUSPENSION;ORAL 021052-001 May 20, 1999 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

Expired US Patents for rofecoxib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck VIOXX rofecoxib TABLET;ORAL 021042-002 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib TABLET;ORAL 021042-001 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib SUSPENSION;ORAL 021052-001 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib TABLET;ORAL 021042-001 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib TABLET;ORAL 021042-002 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib TABLET;ORAL 021042-003 Feb 25, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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