Protamine Sulfate

Sold as Protamine Sulfate. Every FDA application for this active ingredient: 2 branded and 5 generic.

As of Nov 14, 2026, FDA lists 7 applications for Protamine Sulfate (sold as Protamine Sulfate), first approved Aug 13, 1969, with 0 new uses approved and 0 published complete response letters.

First approved: Aug 13, 1969
Applications: 7
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $3K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Protamine Sulfate	Part B	$3K	-16%	480

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Dose for Reversal of Heparin After Cardiopulmonary BypassOpen Heart Surgery · Sohag University	Not applicable	Recruiting	Mar 17, 2026
Antagonization of Heparin With Protamine Sulfate After TAVIAortic Valve Stenosis, Heart Valve Diseases · Assistance Publique - Hôpitaux de Paris	Phase 3	Recruiting	Jan 22, 2024
Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail PatientsFrail Elderly, Coronary Artery Disease · University of Sao Paulo General Hospital	Not applicable	Active, not recruiting	Jan 15, 2015

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 13, 1969	Protamine SulfateNDA 6460 · New formulation or manufacturer	Lilly	22	Discontinued
Nov 5, 1986	Protamine SulfateANDA 89474	Hikma	11	Discontinued
Nov 5, 1986	Protamine SulfateANDA 89475	Hikma	13	Discontinued
Apr 7, 1987	Protamine SulfateANDA 89454	Fresenius Kabi USA	8	Marketed
—	Protamine SulfateANDA 89306	Quad Pharms	0	Discontinued
—	Protamine SulfateANDA 89307	Quad Pharms	0	Discontinued
—	Protamine SulfateNDA 7413	Pharmacia And Upjohn	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA