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Last Updated: March 28, 2024

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 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

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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
Rubicon PRIMIDONE primidone TABLET;ORAL 214896-001 Jun 28, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs PRIMIDONE primidone TABLET;ORAL 083551-001 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Anda Repository PRIMIDONE primidone TABLET;ORAL 040626-001 Sep 29, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon PRIMIDONE primidone TABLET;ORAL 214896-003 Dec 28, 2022 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant MYSOLINE primidone TABLET;ORAL 009170-002 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant MYSOLINE primidone TABLET;ORAL 009170-003 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharm PRIMIDONE primidone TABLET;ORAL 040866-002 Apr 23, 2008 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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