Fosphenytoin sodium - Generic Drug Details
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What are the generic drug sources for fosphenytoin sodium and what is the scope of freedom to operate?
Fosphenytoin sodium
is the generic ingredient in three branded drugs marketed by Parke Davis, Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Norvium Bioscience, Sun Pharm, Wockhardt, and Lupin, and is included in sixteen NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fosphenytoin sodium has fifty-one patent family members in fourteen countries.
There are eight drug master file entries for fosphenytoin sodium. Seven suppliers are listed for this compound.
Summary for fosphenytoin sodium
International Patents: | 51 |
US Patents: | 5 |
Tradenames: | 3 |
Applicants: | 14 |
NDAs: | 16 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 3 |
Patent Applications: | 1,312 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fosphenytoin sodium |
What excipients (inactive ingredients) are in fosphenytoin sodium? | fosphenytoin sodium excipients list |
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 |
Banaras Hindu University | Phase 2 |
Pharmacology 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078417-001 | Mar 18, 2008 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin | SESQUIENT | fosphenytoin sodium | SOLUTION;INTRAVENOUS | 210864-001 | Nov 5, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Lupin | SESQUIENT | fosphenytoin sodium | SOLUTION;INTRAVENOUS | 210864-002 | Nov 5, 2020 | 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 |
Expired US Patents for fosphenytoin sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Parke Davis | CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450-001 | Aug 5, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Parke Davis | CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450-001 | Aug 5, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fosphenytoin sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20150004797 | ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME | ⤷ Sign Up |
Russian Federation | 2014136206 | КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ | ⤷ Sign Up |
European Patent Office | 2268269 | COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fosphenytoin sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0473687 | SPC/GB98/030 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
0473687 | 99C0008 | Belgium | ⤷ Sign Up | PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204 |
0145340 | 99C0005 | Belgium | ⤷ Sign Up | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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