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Last Updated: August 3, 2021

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Enalapril maleate - Generic Drug Details

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What are the generic 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, 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-eight NDAs. There are ten 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-two 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
University of DurhamPhase 3
Newcastle UniversityPhase 3

See all enalapril maleate clinical trials

Generic filers with tentative approvals for ENALAPRIL MALEATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free1MG/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
Beximco Pharms Usa ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075621-001 Aug 22, 2000 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Wockhardt Ltd ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075483-004 Aug 22, 2000 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nostrum Labs Inc ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075178-002 Mar 23, 2001 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taro Pharm Inds ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075788-002 Sep 18, 2001 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Cosette ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075727-001 Sep 18, 2001 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bausch VASERETIC enalapril maleate; hydrochlorothiazide TABLET;ORAL 019221-001 Oct 31, 1986 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-002 Dec 24, 1985 ⤷  Try it Free ⤷  Try it Free
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-003 Dec 24, 1985 ⤷  Try it Free ⤷  Try it Free
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-001 Dec 24, 1985 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for enalapril maleate

Country Patent Number Estimated Expiration
Spain 2770403 ⤷  Try it Free
Canada 2887379 ⤷  Try it Free
Brazil 112015007592 ⤷  Try it Free
European Patent Office 2903690 ⤷  Try it Free
European Patent Office 3429581 ⤷  Try it Free
World Intellectual Property Organization (WIPO) 2017161339 ⤷  Try it Free
Brazil 112018068960 ⤷  Try it Free
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Dow
McKinsey
Express Scripts
Boehringer Ingelheim

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.