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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.
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 |
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
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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