SOTALOL HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for sotalol hydrochloride and what is the scope of freedom to operate?

Sotalol hydrochloride is the generic ingredient in five branded drugs marketed by Altathera Pharms Llc, Azurity, Legacy Pharma, Aiping Pharm Inc, 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 twenty-one NDAs. There are eight 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 seven drug master file entries for sotalol hydrochloride. Twenty-three suppliers are listed for this compound.

Summary for SOTALOL HYDROCHLORIDE

International Patents:	1
US Patents:	8
Tradenames:	5
Applicants:	16
NDAs:	21
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	44
Patent Applications:	5,021
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

See all SOTALOL HYDROCHLORIDE clinical trials

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

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for SOTALOL HYDROCHLORIDE

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for SOTALOL HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075238-004	Jul 13, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075366-001	May 1, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	077070-003	Nov 4, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Beximco Pharms Usa	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	207428-001	Oct 21, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	076576-003	Apr 8, 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

International Patents for SOTALOL HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015153762		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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