zinc sulfate - Profile
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What are the generic sources for zinc sulfate and what is the scope of patent protection?
Zinc sulfate
is the generic ingredient in one branded drug marketed by Abraxis Pharm, Am Regent, Apotex, Aspiro, Fresenius Kabi Usa, Gland, Nivagen Pharms Inc, Somerset Theraps Llc, Stira, and Zydus Pharms, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There is one tentative approval for this compound.
Summary for zinc sulfate
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 10 |
| NDAs: | 10 |
Generic filers with tentative approvals for ZINC SULFATE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 1000UG/1ML | INJECTION |
| ⤷ Start Trial | ⤷ Start Trial | 3MG/1ML | INJECTION |
| ⤷ Start Trial | ⤷ Start Trial | 60UG/1ML | INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for zinc sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abraxis Pharm | ZINC SULFATE | zinc sulfate | INJECTABLE;INJECTION | 019229-002 | May 5, 1987 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Am Regent | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 209377-003 | Apr 15, 2020 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Am Regent | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 209377-002 | Jul 18, 2019 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Am Regent | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 209377-001 | Jul 18, 2019 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Apotex | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 218059-002 | Oct 28, 2024 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Apotex | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 218059-001 | Jun 10, 2024 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
