TOLMETIN SODIUM - Generic Drug Details

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What are the generic sources for tolmetin sodium and what is the scope of patent protection?

Tolmetin sodium is the generic ingredient in four branded drugs marketed by Ortho Mcneil Janssen, Ani Pharms, Chartwell Rx, Rising, Sun Pharm Industries, Teva, and Cosette, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for tolmetin sodium. Three suppliers are listed for this compound.

Summary for TOLMETIN SODIUM

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	16
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	1
Patent Applications:	2,032
What excipients (inactive ingredients) are in TOLMETIN SODIUM?	TOLMETIN SODIUM excipients list
DailyMed Link:	TOLMETIN SODIUM at DailyMed

Recent Clinical Trials for TOLMETIN SODIUM

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

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all TOLMETIN SODIUM clinical trials

Pharmacology for TOLMETIN SODIUM

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for TOLMETIN SODIUM

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TOLMETIN SODIUM

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

US Patents and Regulatory Information for TOLMETIN SODIUM

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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
Ani Pharms	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	073527-001	Jun 30, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	073310-001	Nov 27, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073519-001	May 29, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	074473-001	Aug 30, 1994		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	074002-001	Sep 27, 1993		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 TOLMETIN SODIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Janssen	TOLECTIN DS	tolmetin sodium	CAPSULE;ORAL	018084-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ortho Mcneil Janssen	TOLECTIN	tolmetin sodium	TABLET;ORAL	017628-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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