FDA Orange Book · active-ingredient family
Lisinopril
Lisinopril: 3 brands, 20 generics; first approved Dec 29, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
20
Listed patents
12
Next patent expiry
Nov 06, 2035
in 9 yr 3 mo
Brand (NDA) products
Originator applications
- AZURITYNDA 2084012016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ZESTRILRLDTWI PHARMSNDA 01977719936 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - MERCKNDA 01955819945 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 2.5MG TABLET ORAL Discontinued —
Generic (ANDA) products (20)
Abbreviated applications
- LISINOPRILANNORA PHARMAANDA 2184192026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - LISINOPRILSCIEGEN PHARMSANDA 20892020213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILSCIEGEN PHARMSANDA 21204120203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - LISINOPRILINVAGEN PHARMSANDA 20350820136 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILACCORD HLTHCAREANDA 20255420136 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - LISINOPRILWOCKHARDT BIO AGANDA 07840220076 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILAUROBINDOANDA 07762220066 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILLUPINANDA 07732120056 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILCOREPHARMAANDA 07610220026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILANNORA PHARMAANDA 07590320026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILCHARTWELL RXANDA 07599420026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILHERITAGE PHARMAANDA 07575220026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - LISINOPRILHIKMA INTL PHARMSANDA 07606320026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - LISINOPRILPRINSTON INCANDA 07574320026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - LISINOPRILPRINSTON INCANDA 07616420026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - LISINOPRILRISINGANDA 07599920026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - LISINOPRILSTRIDES PHARMAANDA 07607120026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - LISINOPRILSUN PHARM INDS LTDANDA 07594420026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - LISINOPRILTEVAANDA 07578320026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - LISINOPRILWATSON LABSANDA 07605920026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9616096 | in 9 yr 3 mo | U-3 | |
| 10039800 | in 9 yr 3 mo | U-8 | |
| 10406199 | in 9 yr 3 mo | U-1864 | |
| 12433931 | in 9 yr 3 mo | U-1723 | |
| 10265370 | in 9 yr 3 mo | Product | |
| 9463183 | in 9 yr 3 mo | Product | |
| 11179434 | in 9 yr 3 mo | Product | |
| 9814751 | in 9 yr 3 mo | Product | |
| 10940177 | in 9 yr 3 mo | Product | |
| 11771733 | in 9 yr 3 mo | Product | |
| 12186360 | in 9 yr 3 mo | Product | |
| 12128083 | in 9 yr 3 mo | Product |
Approval history
FDA approval span
First approval
39 yr 4 mo ago
Most recent approval
1 mo ago
Approvals span 1987–2026 across 23 FDA applications.
Brand (NDA) 313%
Generic (ANDA) 2087%
Lisinopril: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
