Phenytoin sodium - Generic Drug Details
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What are the generic drug sources for phenytoin sodium and what is the scope of patent protection?
Phenytoin sodium
is the generic ingredient in seven branded drugs marketed by Viatris, Chartwell Molecular, Amneal Pharms Ny, Ani Pharms, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Unichem, Wockhardt, Wockhardt Usa, Watson Labs, Aurobindo Pharma, Pharmeral, Parke Davis, 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 thirty-three NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for phenytoin sodium. Twenty-four suppliers are listed for this compound.
Summary for phenytoin sodium
US Patents: | 0 |
Tradenames: | 7 |
Applicants: | 25 |
NDAs: | 33 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 248 |
Clinical Trials: | 19 |
Patent Applications: | 6,620 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in phenytoin sodium? | phenytoin sodium excipients list |
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 |
Cambridge University Hospitals NHS Foundation Trust | Phase 3 |
Pharmacology 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 089744-001 | Dec 18, 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 | |||
Fresenius Kabi Usa | PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 089003-001 | May 31, 1985 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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 | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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