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Enalapril maleate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for enalapril maleate?

Enalapril maleate is the generic ingredient in seven branded drugs marketed by Watson Labs, Silvergate Pharms, Sandoz Inc, Sandoz, Sun Pharm Inds Ltd, Taro, Krka Dd Novo Mesto, Mylan, Apotex, Teva, Ivax Sub Teva Pharms, Apothecon, Wockhardt Usa, Valeant Pharms North, Astrazeneca, Dr Reddys Labs Ltd, Upsher-smith Labs, Valeant Intl, G And W Labs Inc, Apotex Inc, and Taro Pharm Inds, 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 three patent family members in three countries.

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

Summary for Generic Name: enalapril maleate

Tradenames:7
Patents:3
Applicants:21
NDAs:28
Drug Master File Entries: see list27
Suppliers / Packagers: see list41
Bulk Api Vendors: see list68
Clinical Trials: see list100
Patent Applications: see list6,521
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:enalapril maleate at DailyMed

Pharmacology for Ingredient: enalapril maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
enalapril maleate; hydrochlorothiazide
TABLET;ORAL075624-002Sep 18, 2001RXNoNo► Subscribe► Subscribe
Taro
ENALAPRIL MALEATE
enalapril maleate
TABLET;ORAL075657-002Jan 23, 2001RXNoNo► Subscribe► Subscribe
Valeant Pharms North
VASOTEC
enalapril maleate
TABLET;ORAL018998-005Jul 26, 1988RXYesNo► Subscribe► Subscribe
Sandoz Inc
ENALAPRIL MALEATE
enalapril maleate
TABLET;ORAL075621-003Aug 22, 2000DISCNNoNo► Subscribe► Subscribe
Mylan
ENALAPRIL MALEATE
enalapril maleate
TABLET;ORAL075480-002Aug 22, 2000RXNoNo► 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 North
VASOTEC
enalapril maleate
TABLET;ORAL018998-005Jul 26, 19884,374,829*PED► Subscribe
Valeant Pharms North
VASOTEC
enalapril maleate
TABLET;ORAL018998-001Dec 24, 19854,374,829*PED► Subscribe
Valeant Pharms North
VASOTEC
enalapril maleate
TABLET;ORAL018998-003Dec 24, 19854,374,829*PED► Subscribe
Valeant Pharms North
VASOTEC
enalapril maleate
TABLET;ORAL018998-002Dec 24, 19854,374,829*PED► Subscribe
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International Patent Family for Ingredient: enalapril maleate

Country Document Number Estimated Expiration
European Patent Office2903690► Subscribe
Canada2887379► 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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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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