FDA Orange Book · active-ingredient family
Enalapril maleate
Enalapril maleate is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EPANED · NDA 208686
3
Brand (NDA)
23
Generics (ANDA)
13
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPANEDRLD | AZURITY | NDA 208686 | AB | Sep 20, 2016 | |
| EPANED KITRLD | AZURITY | NDA 204308 | — | Aug 13, 2013 | |
| VASOTECRLD×4 | BAUSCH | NDA 018998 | AB | Jul 26, 1988 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENALAPRIL MALEATE×4 | UNIQUE PHARM | ANDA 218531 | AB | Sep 19, 2024 | |
| ENALAPRIL MALEATE | AUROBINDO PHARMA | ANDA 216458 | AB | Jan 08, 2024 | |
| ENALAPRIL MALEATE×4 | PRINSTON INC | ANDA 213273 | AB | Jul 07, 2022 | |
| ENALAPRIL MALEATE | AMNEAL | ANDA 212894 | AB | Jun 29, 2022 | |
| ENALAPRIL MALEATE | ALKEM LABS LTD | ANDA 213714 | AB | Mar 30, 2022 | |
| ENALAPRIL MALEATE | ANNORA PHARMA | ANDA 214467 | AB | Feb 24, 2022 | |
| ENALAPRIL MALEATE | BIONPHARMA | ANDA 212408 | AB | Aug 10, 2021 | |
| ENALAPRIL MALEATE×4 | AIPING PHARM INC | ANDA 075178 | AB | Mar 23, 2001 | |
| ENALAPRIL MALEATE×4 | TARO | ANDA 075657 | AB | Jan 23, 2001 | |
| ENALAPRIL MALEATE×4 | APOTHECON | ANDA 075583 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | AUROBINDO PHARMA USA | ANDA 075480 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | CHARTWELL RX | ANDA 075048 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | HERITAGE PHARMA | ANDA 075479 | AB | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | IVAX SUB TEVA PHARMS | ANDA 075482 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×2 | KRKA DD NOVO MESTO | ANDA 075370 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×2 | KRKA DD NOVO MESTO | ANDA 075369 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | MYLAN | ANDA 075472 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | REGCON HOLDINGS | ANDA 075621 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×2 | SANDOZ INC | ANDA 075496 | AB | Aug 22, 2000 | |
| ENALAPRIL MALEATE×2 | SANDOZ INC | ANDA 075459 | AB | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | SENORES PHARMS | ANDA 075483 | AB | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | SUN PHARM INDS LTD | ANDA 075556 | — | Aug 22, 2000 | |
| ENALAPRIL MALEATE×4 | WATSON LABS | ANDA 075501 | — | Aug 22, 2000 |
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8778366 | Nov 06, 2032 | in 6 yr 6 mo | U-3 |
| 9968553 | Nov 06, 2032 | in 6 yr 6 mo | U-71 |
| 8568747 | Nov 06, 2032 | in 6 yr 6 mo | Product |
| 9855214 | Nov 06, 2032 | in 6 yr 6 mo | Product |
| 9808442 | Mar 25, 2036 | in 9 yr 11 mo | U-71 |
| 10154987 | Mar 25, 2036 | in 9 yr 11 mo | U-3 |
| 11040023 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 9669008 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 10772868 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 10786482 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 10039745 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 11173141 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 11141405 | Mar 25, 2036 | in 9 yr 11 mo | Product |
Enalapril maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
