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Last Updated: November 27, 2022

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.

Drug Prices for indomethacin

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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

SponsorPhase
Mayo ClinicEarly Phase 1
Azienda Unità Sanitaria Locale Reggio EmiliaPhase 3
Johns Hopkins UniversityPhase 3

See all indomethacin clinical trials

Pharmacology for indomethacin

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
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

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

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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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
McKinsey
Harvard Business School
Boehringer Ingelheim
AstraZeneca

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.