Primidone - Generic Drug Details

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What are the generic sources for primidone and what is the scope of freedom to operate?

Primidone is the generic ingredient in two branded drugs marketed by Fhta, Valeant, Amneal Pharm, Anda Repository, Carnegie, Dr Reddys Labs Ltd, Hikma Intl Pharms, Impax Labs, Lannett, Oxford Pharms, Rubicon, and Watson Labs, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for primidone. Twenty-one suppliers are listed for this compound.

Summary for primidone

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	24
Patent Applications:	6,442
Drug Prices:	Drug price trends for primidone
Drug Sales Revenues:	Drug sales revenues for primidone
What excipients (inactive ingredients) are in primidone?	primidone excipients list
DailyMed Link:	primidone at DailyMed

See drug prices for primidone

See drug sales revenues for primidone

Recent Clinical Trials for primidone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
KABS laboratories	Phase 2
Dr. Jurjan Aman	Phase 2
Exvastat Ltd.	Phase 2

See all primidone clinical trials

Pharmacology for primidone

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for primidone

Anticonvulsants

Anatomical Therapeutic Chemical (ATC) Classes for primidone

N03AA	Barbiturates and derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for primidone

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Glossary

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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
Dr Reddys Labs Ltd	PRIMIDONE	primidone	TABLET;ORAL	040862-002	Oct 3, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett	PRIMIDONE	primidone	TABLET;ORAL	084903-001	Approved Prior to Jan 1, 1982	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Oxford Pharms	PRIMIDONE	primidone	TABLET;ORAL	040586-001	Feb 24, 2005	AB	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

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