Cysteine hydrochloride - Generic Drug Details

What are the generic sources for cysteine hydrochloride and what is the scope of freedom to operate?

Cysteine hydrochloride is the generic ingredient in three branded drugs marketed by Hospira, Dr Reddys Labs Sa, Exela Pharma, and Baxter Hlthcare Corp, and is included in four NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteine hydrochloride has one patent family member in one country.

There are two drug master file entries for cysteine hydrochloride. Two suppliers are listed for this compound.

Summary for cysteine hydrochloride

International Patents:	1
US Patents:	14
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	210
Clinical Trials:	237
Patent Applications:	3,158
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cysteine hydrochloride
What excipients (inactive ingredients) are in cysteine hydrochloride?	cysteine hydrochloride excipients list
DailyMed Link:	cysteine hydrochloride at DailyMed

Recent Clinical Trials for cysteine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 2
The First Affiliated Hospital of Soochow University	Phase 3
Chinese PLA General Hospital	Phase 1/Phase 2

See all cysteine hydrochloride clinical trials

Paragraph IV (Patent) Challenges for CYSTEINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELCYS	Injection	cysteine hydrochloride	500 mg/10 mL	210660	1	2019-12-10

US Patents and Regulatory Information for cysteine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y
Hospira	CYSTEINE HYDROCHLORIDE	cysteine hydrochloride	INJECTABLE;INJECTION	019523-001	Oct 22, 1986		DISCN	Yes	No

International Patents for cysteine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	3070798	COMPOSITION DE CYSTEINE ET INJECTION (CYSTEINE COMPOSITION AND INJECTION)

Supplementary Protection Certificates for cysteine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0107734	93C0042	Belgium		PROD. NAME TETRAKIS (2-METHOXY-ISOBUTYL-ISONITRILE). CUIVRE (I) TETRAFLUOROBORATE, DIHYDRATE DE CHLORURE STANNEUX, CHLORHYDRATE DE L-CYSTEINE (MONOHYDRATE); REG NO/DATE 923 IS 3 F 12/ 19900924 ; FIRST REG CC NO DATE IE PA 200/9/1 19900817