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, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott, 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.

Sponsor	Phase
Shaheed Zulfiqar Ali Bhutto Medical University	N/A
Hospital Israelita Albert Einstein	Phase 4
Industria Farmacêutica Health Meds	Phase 4

Sponsor

Phase

Shaheed Zulfiqar Ali Bhutto Medical University

N/A

Hospital Israelita Albert Einstein

Phase 4

Industria Farmacêutica Health Meds

Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040731-001	Jun 30, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040298-001	Dec 28, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040435-001	Jun 20, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	211633-001	Sep 30, 2019		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

US Patents:	0
Tradenames:	7
Applicants:	25
NDAs:	33
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	193
Clinical Trials:	20
Patent Applications:	6,664
What excipients (inactive ingredients) are in phenytoin sodium?	phenytoin sodium excipients list
DailyMed Link:	phenytoin sodium at DailyMed

Drug Class	Anti-epileptic Agent
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inducers Cytochrome P450 3A Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity