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Last Updated: February 3, 2023

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, 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.

Recent Clinical Trials for cysteine hydrochloride

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

SponsorPhase
Case Comprehensive Cancer CenterPhase 2
The First Affiliated Hospital of Soochow UniversityPhase 3
Chinese PLA General HospitalPhase 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hospira CYSTEINE HYDROCHLORIDE cysteine hydrochloride INJECTABLE;INJECTION 019523-001 Oct 22, 1986 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing 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:

Merck
Harvard Business School
Baxter
Boehringer Ingelheim
Express Scripts
Dow

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