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Last Updated: January 28, 2022

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CYSTEINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug 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.

Recent Clinical Trials for CYSTEINE HYDROCHLORIDE

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

SponsorPhase
Hospital de Clinicas de Porto AlegrePhase 1/Phase 2
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, BrazilPhase 1/Phase 2
University of California, IrvinePhase 1/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 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CYSTEINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0107734 93C0042 Belgium ⤷  Sign up for a Free Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Express Scripts
AstraZeneca
Mallinckrodt
McKinsey

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