PROTAMINE SULFATE Drug Patent Profile
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When do Protamine Sulfate patents expire, and when can generic versions of Protamine Sulfate launch?
Protamine Sulfate is a drug marketed by Fresenius Kabi Usa, Hikma, Lilly, and Pharmacia And Upjohn. and is included in five NDAs.
The generic ingredient in PROTAMINE SULFATE is protamine sulfate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the protamine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Protamine Sulfate
A generic version of PROTAMINE SULFATE was approved as protamine sulfate by FRESENIUS KABI USA on April 7th, 1987.
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Questions you can ask:
- What is the 5 year forecast for PROTAMINE SULFATE?
- What are the global sales for PROTAMINE SULFATE?
- What is Average Wholesale Price for PROTAMINE SULFATE?
Summary for PROTAMINE SULFATE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 17 |
| DailyMed Link: | PROTAMINE SULFATE at DailyMed |
Recent Clinical Trials for PROTAMINE SULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. Antonius Research Fund | Phase 4 |
| St. Antonius Hospital | Phase 4 |
| National Institute of Cardiovascular Diseases, Karachi | Phase 2/Phase 3 |
Pharmacology for PROTAMINE SULFATE
| Drug Class | Heparin Reversal Agent |
| Mechanism of Action | Heparin Binding Activity |
| Physiological Effect | Reversed Anticoagulation Activity |
Anatomical Therapeutic Chemical (ATC) Classes for PROTAMINE SULFATE
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 | ||||
| Lilly | PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 006460-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 089474-001 | Nov 5, 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 |
