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Last Updated: April 16, 2024

Protamine sulfate - Generic Drug Details


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What are the generic drug sources for protamine sulfate and what is the scope of patent protection?

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
Formulation / Manufacturing:see details
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

SponsorPhase
St. Antonius Research FundPhase 4
St. Antonius HospitalPhase 4
National Institute of Cardiovascular Diseases, KarachiPhase 2/Phase 3

See all protamine sulfate clinical trials

Pharmacology for protamine sulfate
Drug ClassHeparin Reversal Agent
Mechanism of ActionHeparin Binding Activity
Physiological EffectReversed 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
Hikma PROTAMINE SULFATE protamine sulfate INJECTABLE;INJECTION 089474-001 Nov 5, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lilly PROTAMINE SULFATE protamine sulfate INJECTABLE;INJECTION 006460-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pharmacia And Upjohn PROTAMINE SULFATE protamine sulfate INJECTABLE;INJECTION 007413-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa PROTAMINE SULFATE protamine sulfate INJECTABLE;INJECTION 089454-001 Apr 7, 1987 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pharmacia And Upjohn PROTAMINE SULFATE protamine sulfate INJECTABLE;INJECTION 007413-002 Aug 2, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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