BETAPACE Drug Patent Profile
When do Betapace patents expire, and what generic alternatives are available?
Betapace is a drug marketed by Legacy and is included in two NDAs.
The generic ingredient in BETAPACE is sotalol hydrochloride. There is one drug master file entry for this compound. Twenty-one 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.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for BETAPACE?
- What are the global sales for BETAPACE?
- What is Average Wholesale Price for BETAPACE?
Summary for BETAPACE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,269 |
| 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 |
|---|---|
| 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
| Drug Class | Antiarrhythmic |
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
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 | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865-001 | Oct 30, 1992 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Legacy | BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151-007 | Apr 2, 2003 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Legacy | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865-003 | Oct 30, 1992 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Legacy | BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151-001 | Feb 22, 2000 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Legacy | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865-005 | Apr 20, 1994 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Legacy | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865-002 | Oct 30, 1992 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Legacy | BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151-006 | Apr 2, 2003 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
