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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

2 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc FDA-2018-P-1808 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Cysteine Hydrochloride Injection 5% containing 34.6 mg/mL of Cysteine base suitable for submission as an ANDA under Section 505(j)(2)(C), with the reference-listed drug being Cysteine Hydrochl	Other	2018-05-09	Open	Lachman Consultant Services, Inc
Regulus Pharmaceutical Consulting, Inc. - Citizen Petition FDA-2008-P-0278 · 5 docket documents Regulus Pharmaceutical Consulting, Inc. filed this citizen petition on behalf of a client requesting that the FDA determine whether Hospira's Cysteine Hydrochloride Injection USP 7.25% (NDA 19-523) was withdrawn from the market for safety or effectiveness reasons, and if not, to accept an ANDA for a	505(q)	2008-05-02	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

98 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 64 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention NCT01878669	Phase 3	Active	Suleyman Demirel University	390	2013-01 → 2026-12
PET-MRI in Chronic Traumatic Brain Injury (CTBI)NCT03241732	N/A	By Invitation	Thomas Jefferson University	150	2017-06-07 → 2027-07-08
Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis NCT03032601	N/A	By Invitation	Thomas Jefferson University	55	2017-01-05 → 2027-07-08
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease NCT02445651	N/A	Completed	Thomas Jefferson University	51	2014-03 → 2022-08-04
L-cysteine Prevents Stomach Exposure to Carcinogenic Acetaldehyde NCT02524262	Phase 2	Completed	Per Hellström	8	2012-12 → 2015-09
The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels NCT01251315	Phase 1	Completed	Charles Drew University of Medicine and Science	24	2010-12 → 2011-06
Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria NCT00004831	N/A	Completed	FDA Office of Orphan Products Development	20	1996-10 → 1998-07
N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence NCT00332605	Phase 2	Completed	University of Chicago	45	2006-06 → 2010-01
Glutamate-Glutamine Cycling (VCYC) During Cocaine Abstinence Using 1H-MRS NCT02124941	Phase 1	Completed	Yale University	6	2014-02 → 2022-08-14
Role of HIV on Glutathione Synthesis and Oxidative Stress NCT01355198	Phase 1	Completed	Baylor College of Medicine	10	2010-08 → 2011-09

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

API Supply Chain1 active DMF1 inactive

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

MIANYANG SHENGSHI HEALTH TECHNOLOGY CO LTDCYSTEINE HYDROCHLORIDE

DMF 433382026

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.