ROFECOXIB - Generic Drug Details

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What are the generic drug 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.

Summary for ROFECOXIB

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	40
Patent Applications:	7,190
DailyMed Link:	ROFECOXIB at DailyMed

Recent Clinical Trials for ROFECOXIB

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

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

See all ROFECOXIB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ROFECOXIB

M01AH	Coxibs
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for ROFECOXIB

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Glossary

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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	021042-002	May 20, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-002	May 20, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-001	May 20, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-001	May 20, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-002	May 20, 1999	⤷ Sign Up	⤷ Sign Up
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-002	May 20, 1999	⤷ Sign Up	⤷ Sign Up
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-001	May 20, 1999	⤷ Sign Up	⤷ Sign Up
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-001	May 20, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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