Indomethacin - Generic Drug Details

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

Indomethacin is the generic ingredient in six branded drugs marketed by Egalet, 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, Ani Pharms, Cadila, Chartwell Molecules, Cycle Pharms Ltd, Duramed Pharms Barr, Glenmark Generics, 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, Genus, Fresenius Kabi Usa, Cosette, Hikma, Recordati Rare, Hospira, Navinta Llc, and West-ward Pharms Int, and is included in seventy 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-one suppliers are listed for this compound.

Summary for indomethacin

International Patents:	37
US Patents:	3
Tradenames:	6
Applicants:	41
NDAs:	70
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	167
Patent Applications:	6,948
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

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
Mayo Clinic	Early Phase 1
Azienda Unità Sanitaria Locale Reggio Emilia	Phase 3
Johns Hopkins University	Phase 3

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
Superpharm	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070487-001	Oct 10, 1986		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Teva	INDOMETHACIN	indomethacin	CAPSULE;ORAL	071343-001	Apr 18, 1988		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Chartwell Molecules	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070651-001	Mar 5, 1986		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Glenmark Pharms Ltd	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	203501-001	Jun 22, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Egalet	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982	See Plans and Pricing	See Plans and Pricing
Egalet	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	See Plans and Pricing	See Plans and Pricing
Egalet	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	See Plans and Pricing	See Plans and Pricing
>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
Japan	2017019848	インドメタシンの新規製剤 (NOVEL FORMULATION OF INDOMETHACIN)	See Plans and Pricing
Australia	2016200397	A Novel Formulation of Indomethacin	See Plans and Pricing
Morocco	33296	صيغة جديدة لإندوميثاسين	See Plans and Pricing
Tunisia	2011000544	A NOVEL FORMUALTION OF INDOMETHACIN	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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