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Indomethacin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for indomethacin?

Indomethacin is the generic ingredient in six branded drugs marketed by Sun Pharm Inds, Sun Pharm Inds Inc, Zydus Pharms Usa Inc, Jubilant Generics, Parke Davis, Hetero Labs Ltd Iii, Inwood Labs, Cycle Pharms Ltd, Pioneer Pharms, Able, Iroko Pharms, G And W Labs, Ivax Sub Teva Pharms, Mylan, Duramed Pharms Barr, Paddock Llc, Chartwell Molecules, Watson Labs, Halsey, Fresenius Kabi Usa, Mylan Pharms Inc, Teva, Aurobindo Pharma Ltd, Pliva, Amneal Pharms, Heritage Pharms Inc, Vintage, Iroko Pharms Llc, Sandoz, Mutual Pharm, Watson Labs Inc, Avanthi Inc, Glenmark Generics, Superpharm, West-ward Pharms Int, Hospira Inc, and Recordati Rare, and is included in sixty-five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-one patent family members in eighteen countries.

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

Summary for Generic Name: indomethacin

Tradenames:6
Patents:4
Applicants:37
NDAs:65
Drug Master File Entries: see list15
Suppliers / Packagers: see list54
Bulk Api Vendors: see list90
Clinical Trials: see list38
Patent Applications: see list8,970
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:indomethacin at DailyMed

Pharmacology for Ingredient: indomethacin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Duramed Pharms Barr
INDOMETHACIN
indomethacin
CAPSULE;ORAL070326-001Oct 18, 1985DISCNNoNo► Subscribe► Subscribe
Teva
INDOMETHACIN
indomethacin
CAPSULE;ORAL071343-001Apr 18, 1988DISCNNoNo► Subscribe► Subscribe
Iroko Pharms Llc
TIVORBEX
indomethacin
CAPSULE;ORAL204768-001Feb 24, 2014RXYesNo► Subscribe► Subscribe
Watson Labs
INDOMETHACIN
indomethacin
CAPSULE;ORAL018690-002Jul 31, 1984DISCNNoNo► Subscribe► Subscribe
Hospira Inc
INDOMETHACIN SODIUM
indomethacin sodium
INJECTABLE;INJECTION204118-001Apr 19, 2016RXNoNo► 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 Pharms
INDOCIN
indomethacin
SUPPOSITORY;RECTAL017814-001Aug 13, 19843,644,630► Subscribe
Iroko Pharms
INDOCIN
indomethacin
SUPPOSITORY;RECTAL017814-001Aug 13, 19843,849,549► Subscribe
Iroko Pharms
INDOCIN SR
indomethacin
CAPSULE, EXTENDED RELEASE;ORAL018185-001Feb 23, 19824,173,626► 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
Israel215872► Subscribe
Australia2010239081► Subscribe
Singapore10201401695V► Subscribe
Japan6043329► Subscribe
African Regional IP Organization (ARIPO)3628► 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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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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