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Serving leading biopharmaceutical companies globally:

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Generated: December 11, 2017

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Verapamil hydrochloride - Generic Drug Details

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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 Mylan, Recro Gainesville, Gd Searle Llc, Mt Adams, Abraxis Pharm, Bedford, Hospira, Intl Medication, Luitpold, Marsam Pharms Llc, Smith And Nephew, Solopak, Exela Pharma Scs 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, Sandoz, Sun Pharm Industries, Warner Chilcott, and Watson Labs, and is included in sixty-two NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Verapamil hydrochloride has nineteen patent family members in sixteen countries.

There are sixteen drug master file entries for verapamil hydrochloride. Thirty-nine suppliers are listed for this compound.

Medical Subject Heading (MeSH) Categories for verapamil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
HospiraVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideINJECTABLE;INJECTION070740-001May 6, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideTABLET;ORAL072923-001Jun 29, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PfizerCALAN SRverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL019152-002Dec 15, 1989DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Heritage Pharms IncVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideTABLET;ORAL071880-001Apr 5, 1988ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
HospiraVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideSOLUTION;INTRAVENOUS070738-001May 6, 1987APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm IndustriesVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideTABLET;ORAL071489-002Jan 13, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ivax Sub Teva PharmsVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL073568-001Jul 31, 1992ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideTABLET;ORAL071483-001Feb 15, 1989ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
BedfordVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideINJECTABLE;INJECTION072888-001Jul 28, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozVERAPAMIL HYDROCHLORIDEverapamil hydrochlorideTABLET;ORAL073168-001Jul 31, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: verapamil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-001Feb 26, 1996► Subscribe► Subscribe
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-001Feb 26, 1996► Subscribe► Subscribe
Recro GainesvilleVERELAN PMverapamil hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020943-003Nov 25, 1998► Subscribe► Subscribe
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-001Feb 26, 1996► Subscribe► Subscribe
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-002Feb 26, 1996► Subscribe► Subscribe
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-002Feb 26, 1996► Subscribe► Subscribe
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-001Feb 26, 1996► Subscribe► Subscribe
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-002Feb 26, 1996► Subscribe► Subscribe
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-002Feb 26, 1996► Subscribe► Subscribe
Gd Searle LlcCOVERA-HSverapamil hydrochlorideTABLET, EXTENDED RELEASE;ORAL020552-001Feb 26, 1996► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: verapamil hydrochloride

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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International Patent Family for Ingredient: verapamil hydrochloride

Country Document Number Estimated Expiration
Australia2337897► Subscribe
World Intellectual Property Organization (WIPO)9737640► Subscribe
Brazil9708528► Subscribe
Australia710389► Subscribe
Hong Kong1020523► Subscribe
Canada2249637► Subscribe
Germany69709101► Subscribe
South Korea20000005230► Subscribe
Canada2586473► Subscribe
Denmark0907358► 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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Serving leading biopharmaceutical companies globally:

Julphar
Accenture
Moodys
Chinese Patent Office
QuintilesIMS
Federal Trade Commission
US Department of Justice
Harvard Business School
Argus Health
Dow

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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