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Generated: August 19, 2017
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 Sun Pharm Inds, Glenmark Pharms Ltd, 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, Chartwell Rx, Chartwell Molecules, Watson Labs, Halsey, Fresenius Kabi Usa, Mylan Pharms Inc, Teva, Aurobindo Pharma Ltd, Pliva, Amneal Pharms, Heritage Pharms Inc, Novast Labs Ltd, 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-seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 6 |
| Patents: | 3 |
| Applicants: | 38 |
| NDAs: | 67 |
| Drug Master File Entries: see list | 15 |
| Suppliers / Packagers: see list | 52 |
| Bulk Api Vendors: see list | 100 |
| Clinical Trials: see list | 116 |
| Patent Applications: see list | 8,887 |
| Therapeutic Class: | Anti-inflammatory Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | indomethacin at DailyMed |
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Iroko Pharms Llc | INDOCIN | indomethacin | CAPSULE;ORAL | 016059-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sandoz | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070674-001 | Apr 29, 1987 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Watson Labs | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070784-001 | Aug 20, 1986 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Able | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 076666-001 | Dec 17, 2003 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Heritage Pharms Inc | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 018851-001 | May 18, 1984 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Iroko Pharms | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Iroko Pharms | INDOCIN SR | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 018185-001 | Feb 23, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Iroko Pharms | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | ► Subscribe | |||||||||||||||||||||||||||
| 9,522,135 | Formulation 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Morocco | 33296 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2017019848 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2759125 | ► Subscribe | |||||||||||||||||||||||||||
| China | 103932988 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 710384 | ► 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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