Lisinopril Patent History and Generic Timeline: From Brand-Name Zestril to Universal Generic Access

What the FDA approval records show

Prinivil was approved under NDA 019558 on 29 December 1987, classified as a Type 1 new molecular entity, and every listed strength (2.5, 5, 10, 20 and 40 mg tablets) now carries a marketing status of discontinued [2].

Zestril's record reads differently. NDA 019777 has an original approval date of 19 May 1988 and a submission classification of Type 5, new formulation or new manufacturer [1]. Drugs@FDA lists TWI Pharms as the NDA holder for Zestril, and six tablet strengths (2.5, 5, 10, 20, 30 and 40 mg) are all listed as prescription products [1].

The liquid version arrived much later: Qbrelis, a 1 mg/mL lisinopril oral solution from Azurity, was approved on 29 July 2016 as a Type 3 new dosage form under NDA 208401 [3].

Where patent numbers and expiration dates fit

Drugs@FDA records approval dates, application types, products and marketing status. The Orange Book is the FDA database of approved drug products with therapeutic-equivalence evaluations [4]. The patent numbers behind lisinopril, the date its compound patent expired, and the date the first generic lisinopril was approved do not appear in the approval records for Prinivil, Zestril or Qbrelis [1][2][3].

Generic lisinopril today: tablets and oral solution

Generic lisinopril tablets are very widely available [1][2][3]. In the Zestril record, Zestril is flagged as the reference listed drug for lisinopril tablets [1]. For the oral solution, the FDA record lists a generic 1 mg/mL product (application 218419, Annora Pharma) as therapeutically equivalent to Qbrelis, with the same TE code of AA [3].

The lisinopril tablets label covers high blood pressure in adults and children 6 years and older, systolic heart failure, and reduction of mortality in hemodynamically stable patients within 24 hours of an acute myocardial infarction [5].