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PROTAMINE SULFATE Drug Profile
When do Protamine Sulfate patents expire, and what generic alternatives are available?
The generic ingredient in PROTAMINE SULFATE is protamine sulfate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the protamine sulfate profile page.
Summary for PROTAMINE SULFATE
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 5 |
Suppliers / Packagers: | 1 |
Clinical Trials: | 729 |
Formulation / Manufacturing: | see details |
Drug Prices: | see details |
DailyMed Link: | PROTAMINE SULFATE at DailyMed |

Pharmacology for PROTAMINE SULFATE
Drug Class | Heparin Reversal Agent |
Mechanism of Action | Heparin Binding Activity |
Physiological Effect | Reversed Anticoagulation Activity |
US Patents and Regulatory Information for PROTAMINE SULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 089454-001 | Apr 7, 1987 | RX | No | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Pharmacia And Upjohn | PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 007413-002 | Aug 2, 1984 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Lilly | PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 006460-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Pharmacia And Upjohn | PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 007413-001 | 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 |