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.
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 |
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
International Patents for cysteine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 3070798 | COMPOSITION DE CYSTEINE ET INJECTION (CYSTEINE COMPOSITION AND INJECTION) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated 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 |