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PROTAMINE SULFATE

NDA

PROTAMINE SULFATE | N007413 | PHARMACIA AND UPJOHN CO

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Protamine Sulfate (2023)

Total Spending

$2K

Total Claims

828

Beneficiaries

670

ASP Price

—

HCPCS: J2720 — Injection, protamine sulfate, per 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

YUKI GOSEI KOGYO CO LTDPROTAMINE SULFATE

DMF 154212000

ALPS PHARMACEUTICAL IND CO LTDPROTAMINE SULFATE

DMF 205382007

AMPHASTAR NANJING PHARMACEUTICALS INC (ANP) AN AMPHASTAR COPROTAMINE SULFATE USP

DMF 304292016

GLAND PHARMA LTDPROTAMINE SULFATE

DMF 365682021

BEIJING SCRIANEN PHARMACEUTICAL CO LTDPROTAMINE SULFATE

DMF 419322025

YUKI GOSEI KOGYO CO LTDInactivePROTAMINE SULFATE

DMF 46261982

RELIABLE CHEMICAL COInactivePROTAMINE SULFATE (BULK)

DMF 66361986

MARINE BIO CO LTDInactivePROTAMINE SULFATE (BULK)

DMF 89981991

BIOCHEM CORPInactivePROTAMINE SULFATE

DMF 149732000

RELIABLE BIOPHARMACEUTICAL LLCInactivePROTAMINE SULFATE USP

DMF 190082005

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 50MG/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 250MG/VIAL

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Aug 2, 1984