FOSPHENYTOIN SODIUM Drug Patent Profile
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Which patents cover Fosphenytoin Sodium, and when can generic versions of Fosphenytoin Sodium launch?
Fosphenytoin Sodium is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Norvium Bioscience, Sun Pharm, and Wockhardt. and is included in fourteen NDAs.
The generic ingredient in FOSPHENYTOIN SODIUM is fosphenytoin sodium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fosphenytoin Sodium
A generic version of FOSPHENYTOIN SODIUM was approved as fosphenytoin sodium by FRESENIUS KABI USA on August 6th, 2007.
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Questions you can ask:
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Summary for FOSPHENYTOIN SODIUM
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 3 |
| Patent Applications: | 830 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOSPHENYTOIN SODIUM |
| DailyMed Link: | FOSPHENYTOIN SODIUM at DailyMed |
Recent Clinical Trials for FOSPHENYTOIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nobelpharma | Phase 3 |
| Shaheed Zulfiqar Ali Bhutto Medical University | N/A |
| Institute of Medical Sciences of the Banaras Hindu University (BHU),India | Phase 2 |
Pharmacology for FOSPHENYTOIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for FOSPHENYTOIN SODIUM
US Patents and Regulatory Information for FOSPHENYTOIN SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078277-001 | Aug 6, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gland Pharma Ltd | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 214926-001 | Oct 13, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex Inc | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078126-001 | Aug 6, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078736-001 | Jun 8, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 077481-001 | Aug 6, 2007 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Wockhardt | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078137-001 | Aug 6, 2007 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Am Regent | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 090099-001 | May 13, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
