INDOCIN Drug Patent Profile
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Which patents cover Indocin, and what generic alternatives are available?
Indocin is a drug marketed by Zyla Life Sciences, Recordati Rare, and Zyla. and is included in five NDAs.
The generic ingredient in INDOCIN is indomethacin sodium. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indomethacin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Indocin
A generic version of INDOCIN was approved as indomethacin sodium by WEST-WARD PHARMS INT on July 16th, 2008.
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Summary for INDOCIN
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 22 |
| Patent Applications: | 6,063 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for INDOCIN |
| What excipients (inactive ingredients) are in INDOCIN? | INDOCIN excipients list |
| DailyMed Link: | INDOCIN at DailyMed |
Recent Clinical Trials for INDOCIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johns Hopkins University | Phase 3 |
| MetroHealth Medical Center | Early Phase 1 |
| Janssen Scientific Affairs, LLC | Phase 2 |
Pharmacology for INDOCIN
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for INDOCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zyla Life Sciences | INDOCIN | indomethacin | CAPSULE;ORAL | 016059-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zyla Life Sciences | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zyla Life Sciences | INDOCIN | indomethacin | CAPSULE;ORAL | 016059-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
Expired US Patents for INDOCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Zyla Life Sciences | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Zyla Life Sciences | 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 |
International Patents for INDOCIN
See the table below for patents covering INDOCIN around the world.
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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 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.
ISSN: 2162-2639
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