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Chinese Patent Office
Covington
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Generated: December 11, 2017

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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-three patent family members in twenty countries.

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

Pharmacology for indomethacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AbleINDOMETHACINindomethacinCAPSULE;ORAL076666-001Dec 17, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Iroko PharmsINDOCINindomethacinSUSPENSION;ORAL018332-001Oct 10, 1985RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd IiiINDOMETHACINindomethacinCAPSULE;ORAL091240-001Apr 12, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsINDOMETHACINindomethacinCAPSULE;ORAL070785-001Aug 20, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Glenmark GenericsINDOMETHACINindomethacinCAPSULE;ORAL091276-002Dec 22, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Iroko Pharms LlcTIVORBEXindomethacinCAPSULE;ORAL204768-002Feb 24, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Parke DavisINDOMETHACINindomethacinCAPSULE;ORAL018806-002Nov 23, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncINDOMETHACINindomethacinCAPSULE;ORAL090403-002Nov 15, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaINDO-LEMMONindomethacinCAPSULE;ORAL070267-001Nov 7, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Iroko Pharms LlcTIVORBEXindomethacinCAPSULE;ORAL204768-001Feb 24, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: indomethacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Iroko PharmsINDOCIN SRindomethacinCAPSULE, EXTENDED RELEASE;ORAL018185-001Feb 23, 1982► Subscribe► Subscribe
Iroko PharmsINDOCINindomethacinSUPPOSITORY;RECTAL017814-001Aug 13, 1984► Subscribe► Subscribe
Iroko PharmsINDOCINindomethacinSUPPOSITORY;RECTAL017814-001Aug 13, 1984► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,095,496Formulation of indomethacin► Subscribe
9,522,135Formulation of indomethacin► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: indomethacin

Country Document Number Estimated Expiration
Japan2012524724► Subscribe
Singapore10201401695V► Subscribe
Mexico2011011226► Subscribe
South Korea20120101285► Subscribe
African Regional IP Organization (ARIPO)3628► Subscribe
South Korea20150030782► Subscribe
Canada2759125► Subscribe
South Korea101743847► Subscribe
Malaysia159208► Subscribe
Morocco33296► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Healthtrust
Covington
Colorcon
Mallinckrodt
Daiichi Sankyo
Harvard Business School
Cerilliant
Medtronic
Julphar
Cantor Fitzgerald

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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