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Last Updated: October 26, 2021

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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 patent protection?

Enalapril maleate is the generic ingredient in seven branded drugs marketed by Silvergate Pharms, Bionpharma Inc, Azurity, Apothecon, Beximco Pharms Usa, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Nostrum Labs Inc, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Watson Labs, Wockhardt Ltd, Bausch, Astrazeneca, Cosette, Dr Reddys Labs Ltd, Taro Pharm Inds, and Upsher Smith Labs, and is included in twenty-nine NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Enalapril maleate has eight patent family members in five countries.

There are twenty-seven drug master file entries for enalapril maleate. Thirty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for enalapril maleate

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Drug Sales Revenue Trends for enalapril maleate

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Recent Clinical Trials for enalapril maleate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Manchester University NHS Foundation TrustPhase 2
South Tees Hospitals NHS Foundation TrustPhase 3
Newcastle-upon-Tyne Hospitals NHS TrustPhase 3

See all enalapril maleate clinical trials

Generic filers with tentative approvals for ENALAPRIL MALEATE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial1MG/MLSOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for enalapril maleate
Medical Subject Heading (MeSH) Categories for enalapril maleate
Paragraph IV (Patent) Challenges for ENALAPRIL MALEATE
Tradename Dosage Ingredient NDA Submissiondate
EPANED SOLUTION;ORAL enalapril maleate 208686 2018-08-31
EPANED KIT FOR SOLUTION;ORAL enalapril maleate 204308 2016-06-21
VASOTEC TABLET;ORAL enalapril maleate 018998

US Patents and Regulatory Information for enalapril maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075583-003 Aug 22, 2000 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Wockhardt Ltd ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075483-003 Aug 22, 2000 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca LEXXEL enalapril maleate; felodipine TABLET, EXTENDED RELEASE;ORAL 020668-002 Oct 28, 1998 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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 enalapril maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-005 Jul 26, 1988 ⤷  Free Forever Trial ⤷  Free Forever Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-002 Dec 24, 1985 ⤷  Free Forever Trial ⤷  Free Forever Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-001 Dec 24, 1985 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Baxter
AstraZeneca
McKesson
Merck

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.