PHENYTOIN SODIUM Drug Patent Profile
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Which patents cover Phenytoin Sodium, and what generic alternatives are available?
Phenytoin Sodium is a drug marketed by Aurobindo Pharma, Pharmeral, Watson Labs, Acella, Am Regent, Fresenius Kabi Usa, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, Warner Chilcott, and West-ward Pharms Int. and is included in sixteen NDAs.
The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Phenytoin Sodium
A generic version of PHENYTOIN SODIUM was approved as phenytoin sodium by WEST-WARD PHARMS INT on December 31st, 1969.
Summary for PHENYTOIN SODIUM
US Patents: | 0 |
Applicants: | 12 |
NDAs: | 16 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 248 |
Clinical Trials: | 19 |
Patent Applications: | 3,509 |
Formulation / Manufacturing: | see details |
DailyMed Link: | PHENYTOIN SODIUM at DailyMed |
Recent Clinical Trials for PHENYTOIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hospital Israelita Albert Einstein | Phase 4 |
Industria FarmacĂȘutica Health Meds | Phase 4 |
University of Cambridge | Phase 3 |
Pharmacology for PHENYTOIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for PHENYTOIN SODIUM
US Patents and Regulatory Information for PHENYTOIN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma | PHENYTOIN SODIUM | phenytoin sodium | CAPSULE;ORAL | 204309-001 | Jun 10, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hospira | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 089521-001 | Mar 17, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Acella | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 040573-001 | Sep 13, 2006 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Smith And Nephew | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 088521-001 | Dec 18, 1984 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hospira | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 089744-001 | Dec 18, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
West-ward Pharms Int | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 084307-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ 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 |