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 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.
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: | 4,018 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for MYSOLINE
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 | ⤷ 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 | |||
| 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
