FDA Orange Book · active-ingredient family
Lisinopril
Lisinopril is approved as 3 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:QBRELIS · NDA 208401
3
Brand (NDA)
19
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QBRELISRLD | AZURITY | NDA 208401 | — | Jul 29, 2016 | |
| ZESTRILRLD×6 | TWI PHARMS | NDA 019777 | AB | Apr 29, 1993 | |
| PRINIVIL×5 | MERCK | NDA 019558 | — | Jan 28, 1994 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LISINOPRIL×3 | SCIEGEN PHARMS | ANDA 208920 | AB | Mar 04, 2021 | |
| LISINOPRIL×3 | SCIEGEN PHARMS | ANDA 212041 | AB | Sep 15, 2020 | |
| LISINOPRIL×6 | INVAGEN PHARMS | ANDA 203508 | AB | Oct 29, 2013 | |
| LISINOPRIL×6 | ACCORD HLTHCARE | ANDA 202554 | — | Jul 30, 2013 | |
| LISINOPRIL×6 | WOCKHARDT BIO AG | ANDA 078402 | AB | Apr 19, 2007 | |
| LISINOPRIL×6 | AUROBINDO | ANDA 077622 | AB | Feb 22, 2006 | |
| LISINOPRIL×6 | LUPIN | ANDA 077321 | AB | Sep 09, 2005 | |
| LISINOPRIL×6 | COREPHARMA | ANDA 076102 | AB | Sep 30, 2002 | |
| LISINOPRIL×6 | ANNORA PHARMA | ANDA 075903 | AB | Jul 01, 2002 | |
| LISINOPRIL×6 | CHARTWELL RX | ANDA 075994 | AB | Jul 01, 2002 | |
| LISINOPRIL×6 | HERITAGE PHARMA | ANDA 075752 | — | Jul 01, 2002 | |
| LISINOPRIL×6 | HIKMA INTL PHARMS | ANDA 076063 | — | Jul 01, 2002 | |
| LISINOPRIL×6 | PRINSTON INC | ANDA 075743 | AB | Jul 01, 2002 | |
| LISINOPRIL×6 | PRINSTON INC | ANDA 076164 | AB | Jul 01, 2002 | |
| LISINOPRIL×6 | RISING | ANDA 075999 | — | Jul 01, 2002 | |
| LISINOPRIL×6 | STRIDES PHARMA | ANDA 076071 | — | Jul 01, 2002 | |
| LISINOPRIL×6 | SUN PHARM INDS LTD | ANDA 075944 | AB | Jul 01, 2002 | |
| LISINOPRIL×6 | TEVA | ANDA 075783 | — | Jul 01, 2002 | |
| LISINOPRIL×6 | WATSON LABS | ANDA 076059 | AB | Jul 01, 2002 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9616096 | Nov 06, 2035 | in 9 yr 6 mo | U-3 |
| 10039800 | Nov 06, 2035 | in 9 yr 6 mo | U-8 |
| 10406199 | Nov 06, 2035 | in 9 yr 6 mo | U-1864 |
| 12433931 | Nov 06, 2035 | in 9 yr 6 mo | U-1723 |
| 10265370 | Nov 06, 2035 | in 9 yr 6 mo | Product |
| 9463183 | Nov 06, 2035 | in 9 yr 6 mo | Product |
| 11179434 | Nov 06, 2035 | in 9 yr 6 mo | Product |
| 9814751 | Nov 06, 2035 | in 9 yr 6 mo | Product |
| 10940177 | Nov 06, 2035 | in 9 yr 6 mo | Product |
| 11771733 | Nov 06, 2035 | in 9 yr 6 mo | Product |
| 12186360 | Nov 06, 2035 | in 9 yr 6 mo | Product |
| 12128083 | Nov 06, 2035 | in 9 yr 6 mo | Product |
Lisinopril — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
