Verapamil hydrochloride - Generic Drug Details

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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, Recro Gainesville, Gd Searle Llc, Mt Adams, Abraxis Pharm, Aurobindo Pharma Ltd, Bedford, Gland Pharma Ltd, Hospira, Intl Medication, Luitpold, 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, Par Pharm, Pliva, Sun Pharm Inds Inc, Actavis Elizabeth, Heritage Pharms Inc, Mutual Pharm, Sun Pharm Industries, Warner Chilcott, Watson Labs, and Yaopharma Co Ltd, and is included in seventy NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for verapamil hydrochloride

US Patents:	0
Tradenames:	7
Applicants:	37
NDAs:	70
Drug Master File Entries:	17
Suppliers / Packagers:	42
Bulk Api Vendors:	118
Clinical Trials:	132
Patent Applications:	4,026
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
National Cancer Institute, Egypt	Early Phase 1
Pr. Semir Nouira	Phase 3
Medical University of Graz	Phase 2

See all verapamil hydrochloride clinical trials

Pharmacology for verapamil hydrochloride

Drug Class	Calcium Channel Blocker
Mechanism of Action	P-Glycoprotein Inhibitors Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A 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	NDA	Submissiondate
VERELAN PM	CAPSULE, EXTENDED RELEASE;ORAL	verapamil hydrochloride	020943	2006-07-20
VERELAN PM	CAPSULE, EXTENDED RELEASE;ORAL	verapamil hydrochloride	020943	2006-05-19
COVERA-HS	TABLET, EXTENDED RELEASE;ORAL	verapamil hydrochloride	020552

US Patents and Regulatory Information for verapamil 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	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	072923-001	Jun 29, 1993		DISCN	No	No	Start Trial	Start Trial				Start Trial
Mylan	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078306-003	Aug 9, 2007		DISCN	No	No	Start Trial	Start Trial				Start Trial
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996		DISCN	No	No	Start Trial	Start Trial				Start Trial
Caplin	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	SOLUTION;INTRAVENOUS	213232-002	Mar 25, 2020	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Intl Medication	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	INJECTABLE;INJECTION	070451-001	Dec 16, 1985		DISCN	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

Expired US Patents for verapamil hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	Start Trial	Start Trial
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996	Start Trial	Start Trial
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	Start Trial	Start Trial
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	Start Trial	Start Trial
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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