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Cysteine hydrochloride - Generic Drug Details

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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, Exela Pharma, and Baxter Hlthcare Corp, and is included in three NDAs. There are twelve 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 fourteen drug master file entries for cysteine hydrochloride. One supplier is listed for this compound.

Summary for cysteine hydrochloride

International Patents:	1
US Patents:	12
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	192
Clinical Trials:	222
Patent Applications:	44
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
Uniformed Services University of the Health Sciences	Phase 2
Boston University	Phase 2
Weill Medical College of Cornell University	Phase 2

See all cysteine hydrochloride clinical trials

Paragraph IV (Patent) Challenges for CYSTEINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ELCYS	SOLUTION;INTRAVENOUS	cysteine hydrochloride	210660	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
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
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y

International Patents for cysteine hydrochloride

Country	Patent Number	Estimated Expiration
Canada	3070798

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