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.
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 |
Recent Clinical Trials for PRIMIDONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dr. Jurjan Aman | Phase 2 |
Exvastat Ltd. | Phase 2 |
Simbec Orion | Phase 2 |
Pharmacology for PRIMIDONE
Drug Class | Anti-epileptic Agent |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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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