cysteine hydrochloride - Profile
✉ Email this page to a colleague
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 twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.There is one tentative approval for this compound.
Summary for cysteine hydrochloride
| International Patents: | 1 |
| US Patents: | 21 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 3 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for cysteine hydrochloride |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cysteine hydrochloride
Generic Entry Dates for cysteine hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
Generic Entry Dates for cysteine hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Generic filers with tentative approvals for CYSTEINE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 500MG/10ML (50MG/ML) | SOLUTION;INTRAVENOUS |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | CYSTEINE HYDROCHLORIDE | cysteine hydrochloride | INJECTABLE;INJECTION | 019523-001 | Oct 22, 1986 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 11,510,942 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 11,969,439 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 10,478,453 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 10,583,155 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 10,653,719 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >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) | ⤷ Start Trial |
| Canada | 3070798 | ⤷ Start Trial | |
| >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 | ⤷ Start 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 |
Cysteine Hydrochloride: Investment Scenario, Market Dynamics, and Financial Trajectory
More… ↓
