INDOMETHACIN - Generic Drug Details

What are the generic drug sources for indomethacin and what is the scope of patent protection?

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, Novast Labs, Rising, 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, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Genus, Fresenius Kabi Usa, Cosette, Zydus, 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:	164
Clinical Trials:	174
Patent Applications:	6,960
Formulation / Manufacturing:	see details
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

See drug sales revenues for INDOMETHACIN

Recent Clinical Trials for INDOMETHACIN

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

Sponsor	Phase
Moti Lal Nehru Medical College	N/A
Changhai Hospital	N/A
GCS Ramsay Santé pour l'Enseignement et la Recherche	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mutual Pharm	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070068-001	Oct 3, 1986		DISCN	No	No
Glenmark Pharms Ltd	INDOMETHACIN	indomethacin	CAPSULE;ORAL	091276-001	Dec 22, 2010	AB	RX	No	No
Jubilant Generics	INDOMETHACIN	indomethacin	CAPSULE;ORAL	205215-001	Aug 25, 2017		DISCN	No	No
Amneal Pharms	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	091549-001	Dec 1, 2010	AB	RX	No	No
Watson Labs	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070529-001	Oct 18, 1985		DISCN	No	No
Heritage Pharma	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070756-001	Feb 12, 1986		DISCN	No	No
Glenmark Pharms Ltd	INDOMETHACIN	indomethacin	CAPSULE;ORAL	091276-002	Dec 22, 2010	AB	RX	No	Yes

Expired US Patents for INDOMETHACIN

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

International Patents for INDOMETHACIN

Country	Patent Number	Title	Estimated Expiration
South Africa	201108646	A NOVEL FORMULATION OF INDOMETHACIN
South Korea	20120101285	A NOVEL FORMULATION OF INDOMETHACIN
Tunisia	2011000544	A NOVEL FORMUALTION OF INDOMETHACIN
Mexico	351930	UNA FORMULACION NOVEDOSA DE INDOMETACINA. (A NOVEL FORMULATION OF INDOMETHACIN.)
South Korea	20140077945	A NOVEL FORMULATION OF INDOMETHACIN
Australia	2016200397	A Novel Formulation of Indomethacin
New Zealand	710384	A novel formulation of indomethacin