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Last Updated: March 29, 2024

PROTAMINE SULFATE Drug Patent Profile


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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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Summary for PROTAMINE SULFATE
Drug patent expirations by year for PROTAMINE SULFATE
Recent Clinical Trials for PROTAMINE SULFATE

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

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Pharmacology for PROTAMINE SULFATE
Drug ClassHeparin Reversal Agent
Mechanism of ActionHeparin Binding Activity
Physiological EffectReversed 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 ⤷  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
Hikma PROTAMINE SULFATE protamine sulfate INJECTABLE;INJECTION 089474-001 Nov 5, 1986 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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