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 twenty 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. There is one tentative approval for this compound.
Summary for CYSTEINE HYDROCHLORIDE
| International Patents: | 1 |
| US Patents: | 20 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 214 |
| Clinical Trials: | 250 |
| Patent Applications: | 1,932 |
| 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 |
|---|---|
| University of California, San Francisco | Phase 4 |
| National Institute on Aging (NIA) | Phase 4 |
| Vanderbilt University Medical Center | Phase 4 |
Generic filers with tentative approvals for CYSTEINE HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Baxter Hlthcare Corp | NOURESS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 212535-001 | Dec 13, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for CYSTEINE HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 3070798 | COMPOSITION DE CYSTEINE ET INJECTION (CYSTEINE COMPOSITION AND INJECTION) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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 |
