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, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott. 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 HIKMA on December 31st, 1969.
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Questions you can ask:
- What is the 5 year forecast for PHENYTOIN?
- What are the global sales for PHENYTOIN?
- What is Average Wholesale Price for PHENYTOIN?
Summary for PHENYTOIN
| US Patents: | 0 |
| Applicants: | 18 |
| NDAs: | 23 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 155 |
| Clinical Trials: | 129 |
| Patent Applications: | 1,606 |
| 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 |
|---|---|
| Takeda | Phase 1 |
| Sohag University | Phase 2/Phase 3 |
| Dr Cipto Mangunkusumo General Hospital | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Marsam Pharms Llc | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 089501-001 | Oct 13, 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 | ||||
| Rising | PHENYTOIN | phenytoin | TABLET, CHEWABLE;ORAL | 200691-001 | Dec 26, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Vistapharm | PHENYTOIN | phenytoin | SUSPENSION;ORAL | 040342-001 | Jan 31, 2001 | DISCN | No | No | ⤷ 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
