PRIMIDONE Drug Patent Profile
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When do Primidone patents expire, and what generic alternatives are available?
Primidone is a drug marketed by 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 eleven NDAs.
The generic ingredient in PRIMIDONE is primidone. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the primidone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Primidone
A generic version of PRIMIDONE was approved as primidone by WATSON LABS on December 31st, 1969.
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Questions you can ask:
- What is the 5 year forecast for PRIMIDONE?
- What are the global sales for PRIMIDONE?
- What is Average Wholesale Price for PRIMIDONE?
Summary for PRIMIDONE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 24 |
| Patent Applications: | 3,962 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Simbec Orion | Phase 2 |
| KABS laboratories | Phase 2 |
| Dr. Jurjan Aman | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharm | PRIMIDONE | primidone | TABLET;ORAL | 040866-001 | Apr 23, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rubicon | PRIMIDONE | primidone | TABLET;ORAL | 214896-003 | Dec 28, 2022 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Ltd | PRIMIDONE | primidone | TABLET;ORAL | 040862-001 | Oct 3, 2008 | 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 |
