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, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott. 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 HIKMA on December 31st, 1969.
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Summary for PHENYTOIN SODIUM
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 193 |
| Clinical Trials: | 20 |
| Patent Applications: | 3,527 |
| DailyMed Link: | PHENYTOIN SODIUM at DailyMed |
Recent Clinical Trials for PHENYTOIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shaheed Zulfiqar Ali Bhutto Medical University | N/A |
| Hospital Israelita Albert Einstein | Phase 4 |
| Industria Farmacêutica Health Meds | Phase 4 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 084307-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Acella | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 040573-001 | Sep 13, 2006 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Smith And Nephew | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 088519-001 | Dec 19, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 089521-001 | Mar 17, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 085434-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Solopak | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 088520-001 | Dec 17, 1984 | 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 |
