BETAPACE AF Drug Patent Profile
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When do Betapace Af patents expire, and when can generic versions of Betapace Af launch?
Betapace Af is a drug marketed by Legacy Pharma and is included in one NDA.
The generic ingredient in BETAPACE AF is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Betapace Af
A generic version of BETAPACE AF was approved as sotalol hydrochloride by TEVA on May 1st, 2000.
Summary for BETAPACE AF
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,311 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BETAPACE AF |
| DailyMed Link: | BETAPACE AF at DailyMed |
Recent Clinical Trials for BETAPACE AF
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beijing CTSmed Co. Ltd | Phase 4 |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Phase 4 |
| Medtronic (Shanghai) Management Co. Ltd. | Phase 4 |
Pharmacology for BETAPACE AF
| Drug Class | Antiarrhythmic |
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
Anatomical Therapeutic Chemical (ATC) Classes for BETAPACE AF
US Patents and Regulatory Information for BETAPACE AF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Legacy Pharma | BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151-006 | Apr 2, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Legacy Pharma | BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151-005 | Mar 14, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Legacy Pharma | BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151-007 | Apr 2, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Legacy Pharma | BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151-001 | Feb 22, 2000 | 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 |
