INDOMETHACIN SODIUM - Generic Drug Details
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What are the generic drug sources for indomethacin sodium and what is the scope of patent protection?
Indomethacin sodium
is the generic ingredient in two branded drugs marketed by Recordati Rare, Hospira, Navinta Llc, and West-ward Pharms Int, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for indomethacin sodium. One supplier is listed for this compound.
Summary for INDOMETHACIN SODIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 33 |
Clinical Trials: | 10 |
Patent Applications: | 5,245 |
Formulation / Manufacturing: | see details |
DailyMed Link: | INDOMETHACIN SODIUM at DailyMed |
Recent Clinical Trials for INDOMETHACIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ciusss de L'Est de l'Île de Montréal | N/A |
Second Affiliated Hospital, School of Medicine, Zhejiang University | N/A |
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Pharmacology for INDOMETHACIN SODIUM
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for INDOMETHACIN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | INDOMETHACIN SODIUM | indomethacin sodium | INJECTABLE;INJECTION | 204118-001 | Apr 19, 2016 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Recordati Rare | INDOCIN | indomethacin sodium | INJECTABLE;INJECTION | 018878-001 | Jan 30, 1985 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
West-ward Pharms Int | INDOMETHACIN SODIUM | indomethacin sodium | INJECTABLE;INJECTION | 078713-001 | Jul 16, 2008 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Navinta Llc | INDOMETHACIN SODIUM | indomethacin sodium | INJECTABLE;INJECTION | 206561-001 | Jul 19, 2017 | AP | RX | No | Yes | ⤷ 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 |
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