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Last Updated: August 8, 2020

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Indomethacin - Generic Drug Details

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What are the generic 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, Acp Nimble, 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-three 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
Hadassah Medical OrganizationPhase 2/Phase 3
Sheba Medical CenterPhase 2/Phase 3
Soroka University Medical CenterPhase 2/Phase 3

See all indomethacin clinical trials

Pharmacology for indomethacin
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs INDOMETHACIN indomethacin CAPSULE, EXTENDED RELEASE;ORAL 204853-001 May 8, 2017 AB RX 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
Zydus Pharms INDOMETHACIN indomethacin CAPSULE, EXTENDED RELEASE;ORAL 202711-001 Sep 25, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa INDOMETHACIN indomethacin INJECTABLE;INJECTION 022536-001 Mar 17, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms INDOMETHACIN indomethacin CAPSULE;ORAL 018730-001 May 4, 1984 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

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

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Mallinckrodt
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