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, Mylan Labs Ltd, 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. Eight 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.
Summary for FOSPHENYTOIN SODIUM
Recent Clinical Trials for FOSPHENYTOIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nobelpharma | Phase 3 |
| Banaras Hindu University | Phase 2 |
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gland Pharma Ltd | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 214926-001 | Oct 13, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex Inc | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078126-001 | Aug 6, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
