INDOMETHACIN Drug Patent Profile
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Which patents cover Indomethacin, and when can generic versions of Indomethacin launch?
Indomethacin is a drug marketed by Able, Amneal Pharms, Aurobindo Pharma, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Novast Labs, Rising, Sandoz, Watson Labs Inc, Zydus Pharms, Ani Pharms, Chartwell Molecules, Cycle, Duramed Pharms Barr, Glenmark Generics, Halsey, Heritage Pharma, Heritage Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Zydus Lifesciences, Fresenius Kabi Usa, Cosette, Zydus, Hikma, Novitium Pharma, Hospira, Navinta Llc, and West-ward Pharms Int. and is included in sixty-four NDAs.
The generic ingredient in INDOMETHACIN 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 Indomethacin
A generic version of INDOMETHACIN was approved as indomethacin sodium by WEST-WARD PHARMS INT on July 16th, 2008.
Summary for INDOMETHACIN
US Patents: | 0 |
Applicants: | 40 |
NDAs: | 64 |
Finished Product Suppliers / Packagers: | 32 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 174 |
Patent Applications: | 4,415 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for INDOMETHACIN |
Drug Sales Revenues: | Drug sales revenues for INDOMETHACIN |
What excipients (inactive ingredients) are in INDOMETHACIN? | INDOMETHACIN excipients list |
DailyMed Link: | INDOMETHACIN at DailyMed |
Recent Clinical Trials for INDOMETHACIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Moti Lal Nehru Medical College | N/A |
Changhai Hospital | N/A |
Ciusss de L'Est de l'Île de Montréal | N/A |
Pharmacology for INDOMETHACIN
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for INDOMETHACIN
US Patents and Regulatory Information for INDOMETHACIN
INDOMETHACIN is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting INDOMETHACIN
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Try a Trial
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus | INDOMETHACIN | indomethacin | SUPPOSITORY;RECTAL | 216184-001 | Aug 2, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mutual Pharm | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070068-001 | Oct 3, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Heritage Pharms | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 018851-001 | May 18, 1984 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070673-001 | Apr 29, 1987 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Watson Labs | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070784-001 | Aug 20, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |