PHENYTOIN Drug Patent Profile
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Which patents cover Phenytoin, and what generic alternatives are available?
Phenytoin is a drug marketed by Actavis Mid Atlantic, Pai Holdings Pharm, Taro, Vistapharm, Epic Pharma Llc, Rising, 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 twenty-three NDAs.
The generic ingredient in PHENYTOIN 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
A generic version of PHENYTOIN was approved as phenytoin sodium by WEST-WARD PHARMS INT on December 31st, 1969.
Summary for PHENYTOIN
| US Patents: | 0 |
| Applicants: | 18 |
| NDAs: | 23 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 155 |
| Clinical Trials: | 127 |
| Patent Applications: | 4,038 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PHENYTOIN |
| Drug Sales Revenues: | Drug sales revenues for PHENYTOIN |
| What excipients (inactive ingredients) are in PHENYTOIN? | PHENYTOIN excipients list |
| DailyMed Link: | PHENYTOIN at DailyMed |
Recent Clinical Trials for PHENYTOIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sohag University | Phase 2/Phase 3 |
| Dr Cipto Mangunkusumo General Hospital | Phase 4 |
| Wayne State University | Phase 4 |
Pharmacology for PHENYTOIN
Medical Subject Heading (MeSH) Categories for PHENYTOIN
Anatomical Therapeutic Chemical (ATC) Classes for PHENYTOIN
US Patents and Regulatory Information for PHENYTOIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Mid Atlantic | PHENYTOIN | phenytoin | SUSPENSION;ORAL | 089892-001 | Sep 25, 1992 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Marsam Pharms Llc | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 089779-001 | Nov 27, 1992 | 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 | |||
| Rising | PHENYTOIN | phenytoin | TABLET, CHEWABLE;ORAL | 200691-001 | Dec 26, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Vistapharm | PHENYTOIN | phenytoin | SUSPENSION;ORAL | 040342-001 | Jan 31, 2001 | AB | RX | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
