Last Updated: August 2, 2026

lisinopril - Profile


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What are the generic sources for lisinopril and what is the scope of freedom to operate?

Lisinopril is the generic ingredient in four branded drugs marketed by Azurity, Accord Hlthcare, Annora Pharma, Aurobindo, Chartwell Rx, Corepharma, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Prinston Inc, Rising, Sciegen Pharms, Strides Pharma, Sun Pharm Inds Ltd, Teva, Watson Labs, Wockhardt Bio Ag, Merck, and Twi Pharms, and is included in twenty-two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lisinopril has ten patent family members in eight countries.

Summary for lisinopril
International Patents:10
US Patents:12
Tradenames:4
Applicants:20
NDAs:22
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for lisinopril
Paragraph IV (Patent) Challenges for LISINOPRIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
QBRELIS Oral Solution lisinopril 1 mg/mL 208401 1 2019-10-24

US Patents and Regulatory Information for lisinopril

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes 9,616,096 ⤷  Start Trial ⤷  Start Trial
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes 10,039,800 ⤷  Start Trial ⤷  Start Trial
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes 10,406,199 ⤷  Start Trial ⤷  Start Trial
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes 12,433,931 ⤷  Start Trial ⤷  Start Trial
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes 10,265,370 ⤷  Start Trial Y ⤷  Start Trial
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes 9,463,183 ⤷  Start Trial Y ⤷  Start Trial
Azurity QBRELIS lisinopril SOLUTION;ORAL 208401-001 Jul 29, 2016 RX Yes Yes 11,179,434 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for lisinopril

Country Patent Number Title Estimated Expiration
Canada 3003274 FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS) ⤷  Start Trial
China 108472252 赖诺普利制剂 (LISINOPRIL FORMULATIONS) ⤷  Start Trial
China 112972370 赖诺普利制剂 (LISINOPRIL FORMULATIONS) ⤷  Start Trial
European Patent Office 3368012 FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS) ⤷  Start Trial
European Patent Office 3960156 FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS) ⤷  Start Trial
Spain 2886869 ⤷  Start Trial
Hong Kong 1258803 賴諾普利製劑 (LISINOPRIL FORMULATIONS) ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

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