BETAPACE Drug Patent Profile
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Which patents cover Betapace, and when can generic versions of Betapace launch?
Betapace is a drug marketed by Legacy Pharma and is included in two NDAs.
The generic ingredient in BETAPACE 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
A generic version of BETAPACE was approved as sotalol hydrochloride by TEVA on May 1st, 2000.
Summary for BETAPACE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,311 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BETAPACE |
| What excipients (inactive ingredients) are in BETAPACE? | BETAPACE excipients list |
| DailyMed Link: | BETAPACE at DailyMed |
Recent Clinical Trials for BETAPACE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medtronic (Shanghai) Management Co. Ltd. | Phase 4 |
| Beijing CTSmed Co. Ltd | Phase 4 |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Phase 4 |
Pharmacology for BETAPACE
| Drug Class | Antiarrhythmic |
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
Anatomical Therapeutic Chemical (ATC) Classes for BETAPACE
US Patents and Regulatory Information for BETAPACE
| 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 | sotalol hydrochloride | TABLET;ORAL | 019865-001 | Oct 30, 1992 | AB | RX | Yes | 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 | sotalol hydrochloride | TABLET;ORAL | 019865-003 | Oct 30, 1992 | AB | RX | Yes | 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 | |||
| Legacy Pharma | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865-005 | Apr 20, 1994 | 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 |
