sotalol hydrochloride Drug Patent Profile
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When do Sotalol Hydrochloride patents expire, and what generic alternatives are available?
Sotalol Hydrochloride is a drug marketed by Altathera Pharms Llc, Apotex, Aurobindo Pharma Usa, Beximco Pharms Usa, Epic Pharma Llc, Impax Pharms, Natco Pharma Usa, Oxford Pharms, Rising, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs. and is included in seventeen NDAs. There are four patents protecting this drug.
The generic ingredient in SOTALOL HYDROCHLORIDE 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 Sotalol Hydrochloride
A generic version of sotalol hydrochloride was approved as sotalol hydrochloride by TEVA on May 1st, 2000.
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Summary for sotalol hydrochloride
| US Patents: | 4 |
| Applicants: | 13 |
| NDAs: | 17 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 44 |
| Patent Applications: | 2,999 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sotalol hydrochloride |
| What excipients (inactive ingredients) are in sotalol hydrochloride? | sotalol hydrochloride excipients list |
| DailyMed Link: | sotalol hydrochloride at DailyMed |
Recent Clinical Trials for sotalol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rush University Medical Center | N/A |
| HagaZiekenhuis | Phase 2/Phase 3 |
| Abant Izzet Baysal University | N/A |
Pharmacology for sotalol hydrochloride
| Drug Class | Antiarrhythmic |
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for sotalol hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for sotalol hydrochloride
US Patents and Regulatory Information for sotalol hydrochloride
sotalol hydrochloride is protected by six US patents.
Patents protecting sotalol hydrochloride
Method of initiating and escalating sotalol hydrochloride dosing
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
Method of initiating and escalating sotalol hydrochloride dosing
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Patented Use: INTRAVENOUS SOTALOL DOSING REGIMEN FOR ACHIEVING STEADY STATE EXPOSURE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
Method of administering sotalol IV/switch
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Patented Use: INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
Method of administering sotalol IV/switch
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Patent Expiration: ⤷ Sign Up
Patented Use: USE FOR LOADING DOSE IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM OR FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYCARDIA
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Patented Use: INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 075725-004 | Dec 19, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Natco Pharma Usa | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 075237-003 | May 1, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 075429-001 | May 1, 2000 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 075238-001 | Jul 13, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Industries | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 076576-002 | Apr 8, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 076883-001 | Jul 26, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 075429-004 | May 1, 2000 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
