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Last Updated: October 31, 2024

PRIMIDONE - Generic Drug Details


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What are the generic drug sources for primidone and what is the scope of patent protection?

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.

Drug Prices for PRIMIDONE

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Drug Sales Revenue Trends for PRIMIDONE

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Recent Clinical Trials for PRIMIDONE

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

SponsorPhase
Dr. Jurjan AmanPhase 2
Exvastat Ltd.Phase 2
Simbec OrionPhase 2

See all PRIMIDONE clinical trials

Pharmacology for PRIMIDONE
Medical Subject Heading (MeSH) Categories for PRIMIDONE
Anatomical Therapeutic Chemical (ATC) Classes for PRIMIDONE

US Patents and Regulatory Information for PRIMIDONE

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
Oxford Pharms PRIMIDONE primidone TABLET;ORAL 040586-001 Feb 24, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma Intl Pharms PRIMIDONE primidone TABLET;ORAL 040667-001 Jul 27, 2006 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

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