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Last Updated: January 27, 2023

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, Alkem Labs Ltd, Amneal, Annora Pharma, Bionpharma Inc, Azurity, Aiping Pharm Inc, Apothecon, Aurobindo Pharma Usa, Beximco Pharms Usa, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Watson Labs, Wockhardt Ltd, Bausch, Astrazeneca, Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds, and is included in thirty-three NDAs. There are thirteen 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 eighteen drug master file entries for enalapril maleate. Thirty-one suppliers are listed 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
Newcastle-upon-Tyne Hospitals NHS TrustPhase 3
South Tees Hospitals NHS Foundation TrustPhase 3

See all enalapril maleate clinical trials

Pharmacology for enalapril maleate
Medical Subject Heading (MeSH) Categories for enalapril maleate
Paragraph IV (Patent) Challenges for ENALAPRIL MALEATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPANED Oral Solution enalapril maleate 1 mg/mL 208686 1 2018-08-31
EPANED KIT Powder for Oral Solution enalapril maleate 1 mg/mL 204308 1 2016-06-21

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
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Krka Dd Novo Mesto ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075370-001 Aug 22, 2000 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 076116-001 Sep 19, 2001 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ivax Sub Teva Pharms ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075736-002 Mar 25, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Beximco Pharms Usa ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075621-004 Aug 22, 2000 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ivax Sub Teva Pharms ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075482-003 Aug 22, 2000 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-001 Dec 24, 1985 See Plans and Pricing See Plans and Pricing
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-002 Dec 24, 1985 See Plans and Pricing See Plans and Pricing
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-003 Dec 24, 1985 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for enalapril maleate

Country Patent Number Title Estimated Expiration
European Patent Office 3429581 FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017161339 See Plans and Pricing
Brazil 112015007592 composições de enalapril See Plans and Pricing
European Patent Office 2903690 COMPOSITIONS D'ÉNALAPRIL (ENALAPRIL COMPOSITIONS) See Plans and Pricing
Spain 2770403 See Plans and Pricing
Brazil 112018068960 formulações de enalapril See Plans and Pricing
World Intellectual Property Organization (WIPO) 2014055667 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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 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.