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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fuji
Merck
Boehringer Ingelheim
Medtronic
McKinsey
Julphar
Citi
Cantor Fitzgerald
Argus Health

Generated: December 15, 2017

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Enalapril maleate - Generic Drug Details

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What are the generic drug sources for enalapril maleate and what is the scope of enalapril maleate freedom to operate?

Enalapril maleate
is the generic ingredient in seven branded drugs marketed by Silvergate Pharms, Apotex, Apothecon, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Teva, Watson Labs, Wockhardt Usa, Valeant Pharms North, Astrazeneca, Apotex Inc, Dr Reddys Labs Ltd, G And W Labs Inc, Taro Pharm Inds, Upsher-smith Labs, and Valeant Intl, and is included in twenty-eight NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Enalapril maleate has four patent family members in three countries.

There are twenty-seven drug master file entries for enalapril maleate. Forty suppliers are listed for this compound.

Pharmacology for enalapril maleate

Medical Subject Heading (MeSH) Categories for enalapril maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Wockhardt UsaENALAPRIL MALEATEenalapril maleateTABLET;ORAL075483-003Aug 22, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsENALAPRIL MALEATEenalapril maleateTABLET;ORAL075501-004Aug 22, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ApotheconENALAPRIL MALEATEenalapril maleateTABLET;ORAL075583-002Aug 22, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsENALAPRIL MALEATEenalapril maleateTABLET;ORAL075501-001Aug 22, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ApotheconENALAPRIL MALEATEenalapril maleateTABLET;ORAL075583-004Aug 22, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEenalapril maleate; hydrochlorothiazideTABLET;ORAL076486-001Oct 27, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanENALAPRIL MALEATEenalapril maleateTABLET;ORAL075472-001Aug 22, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ApotexENALAPRIL MALEATEenalapril maleateTABLET;ORAL075178-004Mar 23, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Upsher-smith LabsENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEenalapril maleate; hydrochlorothiazideTABLET;ORAL076116-002Sep 19, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TaroENALAPRIL MALEATEenalapril maleateTABLET;ORAL075657-003Jan 23, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: enalapril maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-005Jul 26, 1988► Subscribe► Subscribe
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-003Dec 24, 1985► Subscribe► Subscribe
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-002Dec 24, 1985► Subscribe► Subscribe
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-001Dec 24, 1985► Subscribe► Subscribe
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International Patent Family for Ingredient: enalapril maleate

Country Document Number Estimated Expiration
Canada2887379► Subscribe
World Intellectual Property Organization (WIPO)2017161339► Subscribe
European Patent Office2903690► Subscribe
World Intellectual Property Organization (WIPO)2014055667► 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:

Chinese Patent Office
Merck
Citi
Cipla
McKesson
Julphar
Mallinckrodt
Baxter
Farmers Insurance
McKinsey

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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