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Last Updated: February 27, 2021

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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 Ltd, 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, Ani Pharms Inc, Cadila, Chartwell Molecules, Cycle Pharms Ltd, Duramed Pharms Barr, Glenmark Generics, Halsey, Heritage, Heritage Pharma, 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 Inc, 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 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
Suppliers / Packagers:	30
Bulk Api Vendors:	143
Clinical Trials:	147
Patent Applications:	6,947
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for indomethacin
Drug Sales Revenues:	Drug sales revenues for indomethacin
DailyMed Link:	indomethacin at DailyMed

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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
Laval University	Phase 3
CHU de Quebec-Universite Laval	Phase 3
Woman's	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

Paragraph IV (Patent) Challenges for INDOMETHACIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
INDOCIN SR	CAPSULE, EXTENDED RELEASE;ORAL	indomethacin	018185

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
Egalet	INDOCIN	indomethacin	SUSPENSION;ORAL	018332-001	Oct 10, 1985		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Hetero Labs Ltd Iii	INDOMETHACIN	indomethacin	CAPSULE;ORAL	091240-001	Apr 12, 2011	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Mylan	INDOMETHACIN	indomethacin	CAPSULE;ORAL	018858-001	Apr 20, 1984		DISCN	No	No	Start Trial	Start Trial				Start Trial
Superpharm	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070488-001	Oct 10, 1986		DISCN	No	No	Start Trial	Start Trial				Start Trial
Watson Labs	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070785-001	Aug 20, 1986		DISCN	No	No	Start Trial	Start Trial				Start Trial
Teva	INDO-LEMMON	indomethacin	CAPSULE;ORAL	070266-001	Nov 7, 1985		DISCN	No	No	Start Trial	Start Trial				Start Trial
>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	Start Trial	Start Trial
Egalet	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	Start Trial	Start Trial
Egalet	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for indomethacin

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Country	Patent Number	Estimated Expiration
Singapore	10201401695V	Start Trial
Denmark	2421513	Start Trial
China	102438594	Start Trial
Israel	215872	Start Trial
New Zealand	595986	Start Trial
Japan	2012524724	Start Trial
>Country	>Patent Number	>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.

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