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Last Updated: March 4, 2021

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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.

Recent Clinical Trials for verapamil hydrochloride

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

SponsorPhase
National Cancer Institute, EgyptEarly Phase 1
Pr. Semir NouiraPhase 3
Medical University of GrazPhase 2

See all verapamil hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for verapamil hydrochloride
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

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

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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