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Last Updated: August 11, 2020

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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

Identify potential brand extensions & 505(b)(2) entrants

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

See all INDOMETHACIN clinical trials

Pharmacology for INDOMETHACIN
Paragraph IV (Patent) Challenges for INDOMETHACIN
Tradename Dosage Ingredient NDA Submissiondate

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:

Boehringer Ingelheim
Johnson and Johnson
Express Scripts

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.