INDOMETHACIN - Generic Drug Details

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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, 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

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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
Zydus Lifesciences	INDOMETHACIN	indomethacin	SUPPOSITORY;RECTAL	216184-001	Aug 2, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Recordati Rare	INDOCIN	indomethacin sodium	INJECTABLE;INJECTION	018878-001	Jan 30, 1985		DISCN	Yes	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
Mylan	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	202139-001	Mar 20, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mutual Pharm	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070068-001	Oct 3, 1986		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
South Africa	201108646	A NOVEL FORMULATION OF INDOMETHACIN	⤷ Sign Up
New Zealand	595986	A novel formulation of indomethacin	⤷ Sign Up
Japan	6239709		⤷ Sign Up
Japan	6043329		⤷ Sign Up
Japan	6027890		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.