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Last Updated: November 2, 2024

INDOMETHACIN Drug Patent Profile


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Which patents cover Indomethacin, and when can generic versions of Indomethacin launch?

Indomethacin is a drug marketed by 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, 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, Teva, Watson Labs, Zydus Lifesciences, Fresenius Kabi Usa, Cosette, Hikma, Novitium Pharma, Hospira, Navinta Llc, and West-ward Pharms Int. and is included in sixty-four NDAs.

The generic ingredient in INDOMETHACIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the indomethacin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Indomethacin

A generic version of INDOMETHACIN was approved as indomethacin sodium by WEST-WARD PHARMS INT on July 16th, 2008.

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Drug patent expirations by year for INDOMETHACIN
Drug Prices for INDOMETHACIN

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Drug Sales Revenue Trends for INDOMETHACIN

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Recent Clinical Trials for INDOMETHACIN

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SponsorPhase
University of MostarPhase 2/Phase 3
GlaxoSmithKlinePhase 1
Moti Lal Nehru Medical CollegeN/A

See all INDOMETHACIN clinical trials

Pharmacology for INDOMETHACIN

US Patents and Regulatory Information for INDOMETHACIN

INDOMETHACIN is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting INDOMETHACIN

COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

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
Mutual Pharm INDOMETHACIN indomethacin CAPSULE;ORAL 070068-001 Oct 3, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Heritage Pharma INDOMETHACIN indomethacin CAPSULE;ORAL 070719-001 Feb 12, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz INDOMETHACIN indomethacin CAPSULE;ORAL 070673-001 Apr 29, 1987 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs INDOMETHACIN indomethacin CAPSULE;ORAL 070784-001 Aug 20, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pioneer Pharms INDOMETHACIN indomethacin CAPSULE;ORAL 070592-001 Aug 11, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz INDOMETHACIN indomethacin CAPSULE;ORAL 070674-001 Apr 29, 1987 AB RX 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

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