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, Rising, Azurity, Gd Searle Llc, Mt Adams, Abraxis Pharm, Acic Pharms, Bedford, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Intl Medication, Luitpold, Mankind Pharma, Marsam Pharms Llc, Smith And Nephew, Solopak, Zydus Pharms, Amneal, Caplin, Exela Pharma, Micro Labs, Nephron, Somerset, Somerset Theraps Llc, Pfizer, Apotex Corp, Cadila Pharms Ltd, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Pliva, 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-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for VERAPAMIL HYDROCHLORIDE

US Patents:	0
Tradenames:	7
Applicants:	41
NDAs:	73
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	150
Patent Applications:	4,483
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
EpiEndo Pharmaceuticals	Phase 1
CTC Clinical Trial Consultants AB	Phase 1
Guangdong Raynovent Biotech Co., Ltd	Phase 1

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

Anatomical Therapeutic Chemical (ATC) Classes for VERAPAMIL HYDROCHLORIDE

C08DA	Phenylalkylamine derivatives
C08D	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

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

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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
Sun Pharm Inds Inc	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090529-003	Dec 30, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gd Searle Llc	CALAN	verapamil hydrochloride	INJECTABLE;INJECTION	019038-001	Mar 30, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	INJECTABLE;INJECTION	070348-001	May 1, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solopak	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	INJECTABLE;INJECTION	070695-001	Jul 31, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Caplin	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	SOLUTION;INTRAVENOUS	213232-001	Mar 25, 2020	AP	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

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	020552-002	Feb 26, 1996	⤷ Sign Up	⤷ Sign Up
Azurity	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-004	May 10, 1996	⤷ Sign Up	⤷ Sign Up
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996	⤷ Sign Up	⤷ Sign Up
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996	⤷ Sign Up	⤷ Sign Up
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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