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, Heritage Pharma, 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
Jubilant Generics	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	202706-001	Oct 5, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Genus	TIVORBEX	indomethacin	CAPSULE;ORAL	204768-001	Feb 24, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Jubilant Generics	INDOMETHACIN	indomethacin	CAPSULE;ORAL	205215-001	Aug 25, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Navinta Llc	INDOMETHACIN SODIUM	indomethacin sodium	INJECTABLE;INJECTION	206561-001	Jul 19, 2017	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	INDOMETHACIN	indomethacin	CAPSULE;ORAL	018730-002	May 4, 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
Tunisia	2011000544	A NOVEL FORMUALTION OF INDOMETHACIN	⤷ Sign Up
Singapore	175315	A NOVEL FORMULATION OF INDOMETHACIN	⤷ Sign Up
Brazil	PI1014275	nova formulação de indometacina	⤷ Sign Up
Ukraine	106231	РАЗОВАЯ ДОЗА ФАРМАЦЕВТИЧЕСКОЙ КОМПОЗИЦИИ ИНДОМЕТАЦИНА (ВАРИАНТЫ);РАЗОВА ДОЗА ФАРМАЦЕВТИЧНОЇ КОМПОЗИЦІЇ ІНДОМЕТАЦИНУ (ВАРІАНТИ) (SINGLE DOSE OF INDOMETHACIN-CONTAINING COMPOSITION)	⤷ Sign Up
Australia	2010239081	A novel formulation of indomethacin	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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