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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

INDOMETHACIN Drug 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 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, 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, Teva, Watson Labs, Fresenius Kabi Usa, Acp Nimble, Hikma, Hospira Inc, Navinta Llc, and West-ward Pharms Int. and is included in sixty-two NDAs.

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

US ANDA 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
Sheba Medical CenterPhase 2/Phase 3
Soroka University Medical CenterPhase 2/Phase 3
Hadassah Medical OrganizationPhase 2/Phase 3

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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
Hikma INDOMETHACIN indomethacin SUSPENSION;ORAL 071412-001 Mar 18, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Jubilant Generics INDOMETHACIN indomethacin CAPSULE;ORAL 205215-002 Aug 25, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage INDOMETHACIN indomethacin CAPSULE;ORAL 018851-001 May 18, 1984 AB RX No No   Start Trial   Start Trial   Start Trial
Pioneer Pharms INDOMETHACIN indomethacin CAPSULE;ORAL 070813-001 Aug 11, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Teva INDOMETHACIN indomethacin CAPSULE;ORAL 071343-001 Apr 18, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan INDOMETHACIN indomethacin CAPSULE;ORAL 070624-001 Sep 4, 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

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Serving leading biopharmaceutical companies globally:

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McKesson

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