BRETYLIUM TOSYLATE - Generic Drug Details
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What are the generic sources for bretylium tosylate and what is the scope of patent protection?
Bretylium tosylate
is the generic ingredient in four branded drugs marketed by Abraxis Pharm, Astrazeneca, Breckenridge, Hikma, Hospira, Intl Medication, Luitpold, Abbott, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for bretylium tosylate.
Summary for BRETYLIUM TOSYLATE
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 11 |
| NDAs: | 17 |
| Drug Master File Entries: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Patent Applications: | 1,975 |
| What excipients (inactive ingredients) are in BRETYLIUM TOSYLATE? | BRETYLIUM TOSYLATE excipients list |
| DailyMed Link: | BRETYLIUM TOSYLATE at DailyMed |
Medical Subject Heading (MeSH) Categories for BRETYLIUM TOSYLATE
US Patents and Regulatory Information for BRETYLIUM TOSYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | BRETYLIUM TOSYLATE | bretylium tosylate | INJECTABLE;INJECTION | 019033-001 | Apr 29, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | BRETYLIUM TOSYLATE | bretylium tosylate | INJECTABLE;INJECTION | 019030-001 | Apr 29, 1986 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Breckenridge | BRETYLIUM TOSYLATE | bretylium tosylate | INJECTABLE;INJECTION | 204386-001 | Dec 21, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | BRETYLIUM TOSYLATE | bretylium tosylate | INJECTABLE;INJECTION | 070546-001 | May 14, 1986 | 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 |
Expired US Patents for BRETYLIUM TOSYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hospira | BRETYLOL | bretylium tosylate | INJECTABLE;INJECTION | 017954-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
