Orange Book product · Brand (NDA)
EPANED
ENALAPRIL MALEATE
At a glance
Sep 20, 2016
Approved
Brand (NDA)
Application
AB
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 20, 2016
9 yr 11 mo ago
Today
Patent 10039745 expires
Listed drug product patent expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 10154987 expires
Listed method-of-use patent (U-3) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 10154987 expires
Listed method-of-use patent (U-1892) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 10154987 expires
Listed method-of-use patent (U-185) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 10154987 expires
Listed method-of-use patent (U-71) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 10154987 expires
Listed method-of-use patent (U-1723) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 10772868 expires
Listed drug product patent expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 10786482 expires
Listed drug product patent expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 11040023 expires
Listed drug product patent expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 11141405 expires
Listed drug product patent expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 11173141 expires
Listed drug product patent expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 9669008 expires
Listed drug product patent expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 9808442 expires
Listed method-of-use patent (U-71) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 9808442 expires
Listed method-of-use patent (U-1723) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 9808442 expires
Listed method-of-use patent (U-185) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 9808442 expires
Listed method-of-use patent (U-1892) expiration.
Mar 25, 2036
in 9 yr 11 mo
Patent 9808442 expires
Listed method-of-use patent (U-3) expiration.
Mar 25, 2036
in 9 yr 11 mo
Pharmaceutical detail
Active ingredient
ENALAPRIL MALEATE
Strength
1MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AB
Application
NDA 208686
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2013EPANED KITBrand (NDA)
NDA 204308 · AZURITY
- 1988VASOTECBrand (NDA)
NDA 018998 · BAUSCH
- 2024ENALAPRIL MALEATEGeneric (ANDA)
ANDA 218531 · UNIQUE PHARM
- 2024ENALAPRIL MALEATEGeneric (ANDA)
ANDA 216458 · AUROBINDO PHARMA
- 2022ENALAPRIL MALEATEGeneric (ANDA)
ANDA 213273 · PRINSTON INC
- 2022ENALAPRIL MALEATEGeneric (ANDA)
ANDA 212894 · AMNEAL
- 2022ENALAPRIL MALEATEGeneric (ANDA)
ANDA 213714 · ALKEM LABS LTD
- 2022ENALAPRIL MALEATEGeneric (ANDA)
ANDA 214467 · ANNORA PHARMA
- 2021ENALAPRIL MALEATEGeneric (ANDA)
ANDA 212408 · BIONPHARMA
- 2001ENALAPRIL MALEATEGeneric (ANDA)
ANDA 075178 · AIPING PHARM INC
- 2001ENALAPRIL MALEATEGeneric (ANDA)
ANDA 075657 · TARO
- 2000ENALAPRIL MALEATEGeneric (ANDA)
ANDA 075583 · APOTHECON
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10039745 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 10154987 | Mar 25, 2036 | in 9 yr 11 mo | U-3 |
| 10154987 | Mar 25, 2036 | in 9 yr 11 mo | U-1892 |
| 10154987 | Mar 25, 2036 | in 9 yr 11 mo | U-185 |
| 10154987 | Mar 25, 2036 | in 9 yr 11 mo | U-71 |
| 10154987 | Mar 25, 2036 | in 9 yr 11 mo | U-1723 |
| 10772868 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 10786482 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 11040023 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 11141405 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 11173141 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 9669008 | Mar 25, 2036 | in 9 yr 11 mo | Product |
| 9808442 | Mar 25, 2036 | in 9 yr 11 mo | U-71 |
| 9808442 | Mar 25, 2036 | in 9 yr 11 mo | U-1723 |
| 9808442 | Mar 25, 2036 | in 9 yr 11 mo | U-185 |
| 9808442 | Mar 25, 2036 | in 9 yr 11 mo | U-1892 |
| 9808442 | Mar 25, 2036 | in 9 yr 11 mo | U-3 |

