Indomethacin sodium - Generic Drug Details
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What are the generic drug sources for indomethacin sodium and what is the scope of freedom to operate?
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.
Summary for indomethacin sodium
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 33 |
| Clinical Trials: | 10 |
| Patent Applications: | 5,245 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Navinta Llc | INDOMETHACIN SODIUM | indomethacin sodium | INJECTABLE;INJECTION | 206561-001 | Jul 19, 2017 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Recordati Rare | INDOCIN | indomethacin sodium | INJECTABLE;INJECTION | 018878-001 | Jan 30, 1985 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| West-ward Pharms Int | INDOMETHACIN SODIUM | indomethacin sodium | INJECTABLE;INJECTION | 078713-001 | Jul 16, 2008 | AP | RX | No | 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 |
