Indomethacin - Generic Drug Details

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

Indomethacin is the generic ingredient in six branded drugs marketed by Zyla, Able, Amneal Pharms, Aurobindo Pharma, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Mylan, Novast Labs, Sandoz, Watson Labs Inc, Zydus Pharms, Teva, Zyla Life Sciences, Ani Pharms, Chartwell Molecules, Cycle, Duramed Pharms Barr, Halsey, Heritage Pharma, Heritage Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Rising, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Genus, Fresenius Kabi Usa, Cosette, Hikma, Novitium Pharma, Recordati Rare, Hospira, Navinta Llc, and West-ward Pharms Int, and is included in seventy-two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indomethacin has thirty-seven patent family members in twenty-one countries.

There are fifteen drug master file entries for indomethacin. Thirty-two suppliers are listed for this compound.

Summary for indomethacin

International Patents:	37
US Patents:	3
Tradenames:	6
Applicants:	43
NDAs:	72
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	178
Drug Prices:	Drug price trends for indomethacin
Drug Sales Revenues:	Drug sales revenues for indomethacin
What excipients (inactive ingredients) are in indomethacin?	indomethacin excipients list
DailyMed Link:	indomethacin at DailyMed

See drug prices for indomethacin

Drug Sales Revenue Trends for indomethacin

See drug sales revenues for indomethacin

Recent Clinical Trials for indomethacin

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

Sponsor	Phase
University of Mostar	Phase 2/Phase 3
GlaxoSmithKline	Phase 1
Moti Lal Nehru Medical College	N/A

See all indomethacin clinical trials

Pharmacology for indomethacin

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

Medical Subject Heading (MeSH) Categories for indomethacin

Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Agents
Cyclooxygenase Inhibitors
Gout Suppressants
Tocolytic Agents

US Patents and Regulatory Information for indomethacin

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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
Genus	TIVORBEX	indomethacin	CAPSULE;ORAL	204768-002	Feb 24, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Inc	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	202572-001	Dec 9, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	INDO-LEMMON	indomethacin	CAPSULE;ORAL	070266-001	Nov 7, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Halsey	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070782-001	Jun 3, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharms	INDOMETHACIN	indomethacin	CAPSULE;ORAL	018851-001	May 18, 1984		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 indomethacin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982	⤷ Sign Up	⤷ Sign Up
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	⤷ Sign Up	⤷ Sign Up
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for indomethacin

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Country	Patent Number	Title	Estimated Expiration
China	102438594	A novel formulation of indomethacin	⤷ Sign Up
Colombia	6470807	UNA FORMULACION NOVEDOSA DE INDOMETACINA	⤷ Sign Up
South Korea	20150030782	A Novel formulation of indomethacin	⤷ Sign Up
Malaysia	159208	A NOVEL FORMULATION OF INDOMETHACIN	⤷ Sign Up
Israel	247034	תכשיר של אינדומטאצין (Formulation of indomethacin)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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