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, Societal Cdmo, 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-four 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: | 44 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 150 |
| Patent Applications: | 4,483 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| CTC Clinical Trial Consultants AB | Phase 1 |
| EpiEndo Pharmaceuticals | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex Corp | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200878-003 | Apr 20, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | TABLET;ORAL | 071483-002 | Feb 15, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Societal Cdmo | VERELAN | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019614-004 | May 10, 1996 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Strides Pharma | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075072-003 | May 25, 1999 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | CALAN | verapamil hydrochloride | TABLET;ORAL | 018817-002 | Sep 10, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | CALAN SR | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 019152-002 | Dec 15, 1989 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Societal Cdmo | VERELAN PM | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020943-001 | Nov 25, 1998 | RX | Yes | 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
| 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 | 020552-002 | Feb 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Societal Cdmo | VERELAN PM | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020943-002 | Nov 25, 1998 | ⤷ 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 |
| 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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DrugPatentWatch Alternatives
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