Sotalol hydrochloride - Generic Drug Details

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What are the generic drug 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.

Sponsor	Phase
Rush University Medical Center	N/A
HagaZiekenhuis	Phase 2/Phase 3
Abant Izzet Baysal University	N/A

Sponsor

Phase

Rush University Medical Center

N/A

HagaZiekenhuis

Phase 2/Phase 3

Abant Izzet Baysal University

N/A

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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
Epic Pharma Llc	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	077070-002	Nov 4, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Legacy Pharma	BETAPACE AF	sotalol hydrochloride	TABLET;ORAL	021151-002	Feb 22, 2000	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Legacy Pharma	BETAPACE AF	sotalol hydrochloride	TABLET;ORAL	021151-006	Apr 2, 2003		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Oxford Pharms	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075563-001	Nov 7, 2003	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Beximco Pharms Usa	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	207428-001	Oct 21, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	076883-001	Jul 26, 2004		DISCN	No	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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015153762		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Country

Patent Number

Title

Estimated Expiration

World Intellectual Property Organization (WIPO)

2015153762

>Country

>Patent Number

>Title

>Estimated Expiration

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:	5,425
Formulation / Manufacturing:	see details
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

Drug Class	Antiarrhythmic
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Cardiac Rhythm Alteration