Verapamil hydrochloride - Generic Drug Details

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

Verapamil hydrochloride is the generic ingredient in seven branded drugs marketed by Mylan, Societal Cdmo, Gd Searle Llc, Mt Adams, Abraxis Pharm, Acic Pharms, Bedford, Eugia Pharma, Gland Pharma Ltd, Hospira, Intl Medication, Luitpold, Mankind Pharma, Marsam Pharms Llc, Smith And Nephew, Solopak, Zydus Pharms, Amneal, Areva Pharms, Caplin, Exela Pharma, Micro Labs, Somerset, Somerset Theraps Llc, Pfizer, Apotex Corp, Cadila Pharms Ltd, Glenmark Generics, Ivax Sub Teva Pharms, Pliva, Rising, Strides Pharma, Sun Pharm Inds Inc, Actavis Elizabeth, Chartwell Rx, Heritage Pharms, Mutual Pharm, Sun Pharm Industries, Warner Chilcott, and Watson Labs, and is included in seventy-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for verapamil hydrochloride. Forty-six suppliers are listed for this compound.

Summary for verapamil hydrochloride

US Patents:	0
Tradenames:	7
Applicants:	40
NDAs:	72
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	141
Patent Applications:	4,269
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for verapamil hydrochloride
What excipients (inactive ingredients) are in verapamil hydrochloride?	verapamil hydrochloride excipients list
DailyMed Link:	verapamil hydrochloride at DailyMed

Recent Clinical Trials for verapamil hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Radboud University Medical Center	Phase 2
Canisius-Wilhelmina Hospital	Phase 2
Leiden University Medical Center	Phase 2

See all verapamil hydrochloride clinical trials

Pharmacology for verapamil hydrochloride

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for verapamil hydrochloride

Anti-Arrhythmia Agents

Calcium Channel Blockers

Vasodilator Agents

Paragraph IV (Patent) Challenges for VERAPAMIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VERELAN PM	Extended-release Capsules	verapamil hydrochloride	100 mg and 200 mg	020943	1	2006-07-20
VERELAN PM	Extended-release Capsules	verapamil hydrochloride	300 mg	020943	1	2006-05-19

US Patents and Regulatory Information for verapamil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cadila Pharms Ltd	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206173-002	May 5, 2017	AB	RX	No	No
Societal Cdmo	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-002	Nov 25, 1998		RX	Yes	No
Pfizer	CALAN	verapamil hydrochloride	TABLET;ORAL	018817-001	Sep 10, 1984		DISCN	Yes	No
Mt Adams	ISOPTIN	verapamil hydrochloride	INJECTABLE;INJECTION	018485-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	CALAN	verapamil hydrochloride	TABLET;ORAL	018817-003	Feb 23, 1988		DISCN	No	No

Expired US Patents for verapamil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996
Societal Cdmo	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-003	Nov 25, 1998
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996