Orange Book product · Brand (NDA)
EPANED KIT
ENALAPRIL MALEATE
At a glance
Aug 13, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 13, 2013
13 yr ago
Today
Patent 8568747 expires
Listed drug product patent expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 8778366 expires
Listed method-of-use patent (U-3) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 8778366 expires
Listed method-of-use patent (U-71) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 8778366 expires
Listed method-of-use patent (U-185) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 8778366 expires
Listed method-of-use patent (U-1723) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 8778366 expires
Listed method-of-use patent (U-1892) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 9855214 expires
Listed drug product patent expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 9968553 expires
Listed method-of-use patent (U-71) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 9968553 expires
Listed method-of-use patent (U-3) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 9968553 expires
Listed method-of-use patent (U-1892) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 9968553 expires
Listed method-of-use patent (U-185) expiration.
Nov 06, 2032
in 6 yr 6 mo
Patent 9968553 expires
Listed method-of-use patent (U-1723) expiration.
Nov 06, 2032
in 6 yr 6 mo
Pharmaceutical detail
Active ingredient
ENALAPRIL MALEATE
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 204308
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2016EPANEDBrand (NDA)
NDA 208686 · 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 (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8568747 | Nov 06, 2032 | in 6 yr 6 mo | Product |
| 8778366 | Nov 06, 2032 | in 6 yr 6 mo | U-3 |
| 8778366 | Nov 06, 2032 | in 6 yr 6 mo | U-71 |
| 8778366 | Nov 06, 2032 | in 6 yr 6 mo | U-185 |
| 8778366 | Nov 06, 2032 | in 6 yr 6 mo | U-1723 |
| 8778366 | Nov 06, 2032 | in 6 yr 6 mo | U-1892 |
| 9855214 | Nov 06, 2032 | in 6 yr 6 mo | Product |
| 9968553 | Nov 06, 2032 | in 6 yr 6 mo | U-71 |
| 9968553 | Nov 06, 2032 | in 6 yr 6 mo | U-3 |
| 9968553 | Nov 06, 2032 | in 6 yr 6 mo | U-1892 |
| 9968553 | Nov 06, 2032 | in 6 yr 6 mo | U-185 |
| 9968553 | Nov 06, 2032 | in 6 yr 6 mo | U-1723 |
