MYSOLINE Drug Patent Profile
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When do Mysoline patents expire, and when can generic versions of Mysoline launch?
Mysoline is a drug marketed by Fhta and Valeant and is included in two NDAs.
The generic ingredient in MYSOLINE 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 Mysoline
A generic version of MYSOLINE was approved as primidone by WATSON LABS on December 31st, 1969.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MYSOLINE?
- What are the global sales for MYSOLINE?
- What is Average Wholesale Price for MYSOLINE?
Summary for MYSOLINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,958 |
| Drug Prices: | Drug price information for MYSOLINE |
| What excipients (inactive ingredients) are in MYSOLINE? | MYSOLINE excipients list |
| DailyMed Link: | MYSOLINE at DailyMed |
Recent Clinical Trials for MYSOLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Jiao Tong University School of Medicine | Phase 2 |
| Dr. Reddy's Laboratories Limited | Phase 1 |
| Mutual Pharmaceutical Company, Inc. | Phase 1 |
Pharmacology for MYSOLINE
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
US Patents and Regulatory Information for MYSOLINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fhta | MYSOLINE | primidone | SUSPENSION;ORAL | 010401-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant | MYSOLINE | primidone | TABLET;ORAL | 009170-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Valeant | MYSOLINE | primidone | TABLET;ORAL | 009170-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | 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 |
