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Generated: June 23, 2017
What are the generic drug sources for primidone and what is the scope of primidone patent protection?
Primidone is the generic ingredient in two branded drugs marketed by Nuro Pharma, Lannett, Impax Labs, Frontida Biopharm, Watson Labs, Dr Reddys Labs Ltd, Amneal Pharm, Hikma Intl Pharms, Valeant, and Vintage Pharms, and is included in eleven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 1 |
| Applicants: | 10 |
| NDAs: | 11 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packagers: see list | 17 |
| Bulk Api Vendors: see list | 61 |
| Clinical Trials: see list | 20 |
| Patent Applications: see list | 4,873 |
| Therapeutic Class: | Anticonvulsants |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | primidone at DailyMed |
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant | MYSOLINE | primidone | TABLET;ORAL | 009170-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Amneal Pharm | PRIMIDONE | primidone | TABLET;ORAL | 040866-002 | Apr 23, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Valeant | MYSOLINE | primidone | TABLET;ORAL | 009170-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Impax Labs | PRIMIDONE | primidone | TABLET;ORAL | 040717-001 | Feb 12, 2008 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Hikma Intl Pharms | PRIMIDONE | primidone | TABLET;ORAL | 040667-001 | Jul 27, 2006 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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