Ethotoin - Generic Drug Details
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What are the generic sources for ethotoin and what is the scope of patent protection?
Ethotoin
is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for ethotoin.
Summary for ethotoin
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Clinical Trials: | 1 |
| Patent Applications: | 3,909 |
| What excipients (inactive ingredients) are in ethotoin? | ethotoin excipients list |
| DailyMed Link: | ethotoin at DailyMed |
Recent Clinical Trials for ethotoin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| Federal University of São Paulo | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ethotoin
US Patents and Regulatory Information for ethotoin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | PEGANONE | ethotoin | TABLET;ORAL | 010841-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Recordati Rare | PEGANONE | ethotoin | TABLET;ORAL | 010841-003 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
