Verapamil hydrochloride - Generic Drug Details
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What are the generic drug sources for verapamil hydrochloride and what is the scope of patent protection?
Verapamil hydrochloride
is the generic ingredient in seven branded drugs marketed by Mylan, Rising, Azurity, Gd Searle Llc, Mt Adams, Abraxis Pharm, Bedford, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Heritage, 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, 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: | 40 |
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 |
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
Anatomical Therapeutic Chemical (ATC) Classes for verapamil hydrochloride
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Azurity | VERELAN | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019614-004 | May 10, 1996 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm Inds Inc | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090529-001 | Dec 30, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hospira | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | SOLUTION;INTRAVENOUS | 070737-001 | May 6, 1987 | AP | RX | No | Yes | ⤷ 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
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 |
Pfizer | COVERA-HS | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020552-001 | Feb 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | COVERA-HS | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020552-001 | Feb 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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