PRONESTYL-SR Drug Patent Profile
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Which patents cover Pronestyl-sr, and what generic alternatives are available?
Pronestyl-sr is a drug marketed by Apothecon and is included in one NDA.
The generic ingredient in PRONESTYL-SR is procainamide hydrochloride. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pronestyl-sr
A generic version of PRONESTYL-SR was approved as procainamide hydrochloride by INTL MEDICATION on July 31st, 1984.
Summary for PRONESTYL-SR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,256 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PRONESTYL-SR at DailyMed |
Recent Clinical Trials for PRONESTYL-SR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jeffrey Moak | Phase 4 |
| Mayo Clinic | Phase 3 |
| Medtronic | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for PRONESTYL-SR
US Patents and Regulatory Information for PRONESTYL-SR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apothecon | PRONESTYL-SR | procainamide hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 087361-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 |
