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Last Updated: March 18, 2024

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 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, 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, 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.

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
Moti Lal Nehru Medical CollegeN/A
Changhai HospitalN/A
Ciusss de L'Est de l'Île de MontréalN/A

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
Sun Pharm Inds Inc INDOMETHACIN indomethacin CAPSULE;ORAL 091401-001 Mar 28, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva INDO-LEMMON indomethacin CAPSULE;ORAL 070267-001 Nov 7, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz INDOMETHACIN indomethacin CAPSULE;ORAL 070673-001 Apr 29, 1987 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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 ⤷  Try a Trial ⤷  Try a Trial
Zyla Life Sciences INDOCIN indomethacin SUPPOSITORY;RECTAL 017814-001 Aug 13, 1984 ⤷  Try a Trial ⤷  Try a Trial
Zyla Life Sciences INDOCIN indomethacin SUPPOSITORY;RECTAL 017814-001 Aug 13, 1984 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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