PROTAMINE SULFATE - Generic Drug Details

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What are the generic 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

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Sponsor	Phase
St. Antonius Hospital	Phase 4
St. Antonius Research Fund	Phase 4
National Institute of Cardiovascular Diseases, Karachi	Phase 2/Phase 3

See all PROTAMINE SULFATE clinical trials

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

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for PROTAMINE SULFATE

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Glossary

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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
>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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