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Serving leading biopharmaceutical companies globally:

Argus Health
Express Scripts
Covington
Fuji
QuintilesIMS
Colorcon
Farmers Insurance
Teva
McKesson
Boehringer Ingelheim

Generated: February 25, 2018

DrugPatentWatch Database Preview

Indomethacin - Generic Drug Details

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What are the generic drug sources for indomethacin and what is the scope of indomethacin patent protection?

Indomethacin
is the generic ingredient in six branded drugs marketed by Iroko Pharms, Able, Amneal Pharms, Aurobindo Pharma Ltd, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Mylan Pharms Inc, Novast Labs Ltd, Sandoz, Watson Labs Inc, Zydus Pharms Usa Inc, Teva, Iroko Pharms Llc, Chartwell Molecules, Cycle Pharms Ltd, Duramed Pharms Barr, Glenmark Generics, Halsey, Heritage Pharms Inc, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Parke Davis, Pioneer Pharms, Pliva, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs, Fresenius Kabi Usa, G And W Labs, 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-four patent family members in twenty countries.

There are fifteen drug master file entries for indomethacin. Fifty-four suppliers are listed for this compound.

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
Watson Labs INDOMETHACIN indomethacin CAPSULE;ORAL 071635-001 May 18, 1987 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc INDOMETHACIN indomethacin CAPSULE, EXTENDED RELEASE;ORAL 202139-001 Mar 20, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hetero Labs Ltd Iii INDOMETHACIN indomethacin CAPSULE, EXTENDED RELEASE;ORAL 201807-001 Sep 28, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Iroko Pharms Llc TIVORBEX indomethacin CAPSULE;ORAL 204768-002 Feb 24, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Chartwell Molecules INDOMETHACIN indomethacin CAPSULE;ORAL 018829-001 Aug 6, 1984 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira Inc INDOMETHACIN SODIUM indomethacin sodium INJECTABLE;INJECTION 204118-001 Apr 19, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Iroko Pharms Llc INDOCIN indomethacin CAPSULE;ORAL 016059-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Heritage Pharms Inc INDOMETHACIN indomethacin CAPSULE;ORAL 018851-001 May 18, 1984 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Chartwell Molecules INDOMETHACIN indomethacin CAPSULE;ORAL 070651-001 Mar 5, 1986 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Duramed Pharms Barr INDOMETHACIN indomethacin CAPSULE;ORAL 070326-001 Oct 18, 1985 DISCN 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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Expired US Patents for indomethacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Iroko Pharms INDOCIN SR indomethacin CAPSULE, EXTENDED RELEASE;ORAL 018185-001 Feb 23, 1982 ➤ Sign Up ➤ Sign Up
Iroko Pharms INDOCIN indomethacin SUPPOSITORY;RECTAL 017814-001 Aug 13, 1984 ➤ Sign Up ➤ Sign Up
Iroko Pharms INDOCIN indomethacin SUPPOSITORY;RECTAL 017814-001 Aug 13, 1984 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for indomethacin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,095,496 Formulation of indomethacin ➤ Sign Up
9,849,111 Formulation of indomethacin ➤ Sign Up
9,522,135 Formulation of indomethacin ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for indomethacin

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
McKesson
Covington
Healthtrust
Fuji
Teva
AstraZeneca
Chubb
Medtronic

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 verifification 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.

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