Protamine sulfate - Generic Drug Details
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What are the generic drug sources for protamine sulfate and what is the scope of freedom to operate?
Protamine sulfate
is the generic ingredient in one branded drug marketed by Fresenius Kabi Usa, Hikma, Lilly, and Pharmacia And Upjohn, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for protamine sulfate. Two suppliers are listed for this compound.
Summary for protamine sulfate
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 9 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 17 |
| What excipients (inactive ingredients) are in protamine sulfate? | protamine sulfate excipients list |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 007413-002 | Aug 2, 1984 | DISCN | No | 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 | ||||
| Hikma | PROTAMINE SULFATE | protamine sulfate | INJECTABLE;INJECTION | 089475-001 | Nov 5, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | 007413-001 | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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