You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Express Scripts
McKesson
Moodys
Dow

Last Updated: March 6, 2021

DrugPatentWatch Database Preview

Sotalol hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic sources for sotalol hydrochloride and what is the scope of patent protection?

Sotalol hydrochloride is the generic ingredient in five branded drugs marketed by Altathera Pharms Llc, Arbor Pharms Llc, Covis, Upsher Smith Labs, Apotex, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford Pharms, Sun Pharm Industries, Teva, and Watson Labs, and is included in twenty-one NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sotalol hydrochloride has one patent family member in one country.

There are ten drug master file entries for sotalol hydrochloride. Nineteen suppliers are listed for this compound.

Summary for sotalol hydrochloride
International Patents:1
US Patents:3
Tradenames:5
Applicants:13
NDAs:21
Drug Master File Entries: 10
Suppliers / Packagers: 19
Bulk Api Vendors: 93
Clinical Trials: 37
Patent Applications: 1,450
Formulation / Manufacturing:see details
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

SponsorPhase
National Institute on Aging (NIA)Phase 4
Weill Medical College of Cornell UniversityPhase 4
Kansas City Heart Rhythm Research FoundationPhase 4

See all sotalol hydrochloride clinical trials

Pharmacology for sotalol hydrochloride
Drug ClassAntiarrhythmic
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories for sotalol hydrochloride

US Patents and Regulatory Information for sotalol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076576-003 Apr 8, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076140-004 Sep 26, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Oxford Pharms SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075563-004 Nov 7, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Teva SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075429-001 May 1, 2000 AB RX 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
Baxter
Mallinckrodt
Express Scripts
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.