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Generated: June 26, 2017
What are the generic sources for verapamil hydrochloride and what is the scope of verapamil hydrochloride freedom to operate?
Verapamil hydrochloride is the generic ingredient in seven branded drugs marketed by Glenmark Generics, Mylan, Recro Gainesville, Luitpold, Gd Searle Llc, Actavis Elizabeth, Pliva, Sandoz, Watson Labs, Exela Pharma Scs Llc, Sun Pharm Inds Inc, Ivax Sub Teva Pharms, Marsam Pharms Llc, Hospira, Warner Chilcott, Abraxis Pharm, Intl Medication, Pfizer, Par Pharm, Cadila Pharms Ltd, Apotex Corp, Heritage Pharms Inc, Mutual Pharm, Mt Adams, Bedford, Sun Pharm Inds, Solopak, and Smith And Nephew, and is included in sixty-two NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 2 |
| Applicants: | 28 |
| NDAs: | 62 |
| Drug Master File Entries: see list | 16 |
| Suppliers / Packagers: see list | 38 |
| Bulk Api Vendors: see list | 71 |
| Clinical Trials: see list | 2,332 |
| Patent Applications: see list | 3,449 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | verapamil hydrochloride at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | TABLET;ORAL | 071483-001 | Feb 15, 1989 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hospira | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | INJECTABLE;INJECTION | 070739-001 | May 6, 1987 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Pfizer | CALAN SR | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 019152-002 | Dec 15, 1989 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Mylan | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 075138-003 | Apr 20, 1999 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mutual Pharm | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | TABLET;ORAL | 070483-001 | Sep 24, 1986 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gd Searle Llc | COVERA-HS | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020552-001 | Feb 26, 1996 | 5,082,668 | ► Subscribe | ||||||||||||||||||||||
Gd Searle Llc | COVERA-HS | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020552-001 | Feb 26, 1996 | 5,141,752 | ► Subscribe | ||||||||||||||||||||||
Gd Searle Llc | COVERA-HS | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020552-002 | Feb 26, 1996 | 4,327,725 | ► Subscribe | ||||||||||||||||||||||
Recro Gainesville | VERELAN | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019614-004 | May 10, 1996 | 4,863,742 | ► Subscribe | ||||||||||||||||||||||
Gd Searle Llc | COVERA-HS | verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020552-001 | Feb 26, 1996 | 4,783,337 | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,534,089 | Uniform drug delivery therapy | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2249637 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 0907358 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2337897 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2000508313 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2586473 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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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 verifification 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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