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CYSTEINE HYDROCHLORIDE

NDA

CYSTEINE HYDROCHLORIDE | N019523 | HOSPIRA INC

1 strength0 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Exela Pharma Sciences, LLC v. Hikma Pharmaceuticals USA Inc. 1:2023cv00137 2 patentsANDA 213073L-cysteine hydrochloride	D. Del.	2023-02-06	Terminated 2023-06-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Atorvastatin Combined With NAC Plus Romiplostim for Management of ITP NCT07662525	N/A	Not Yet Recruiting	Peking University People's Hospital	50	2026-06-01 → 2028-12-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

NIPPON RIKAGAKUYAKUHIN CO LTDInactiveCYSTEINE HYDROCHLORIDE

DMF 107411994

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

Products (1)

#001 — 7.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 22, 1986

No patent or exclusivity listings for this strength.