Orange Book product · Brand (NDA)
NEFFY
EPINEPHRINE
At a glance
Mar 05, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 05, 2025
1 yr 4 mo ago
Today
Patent 10576156 expires
Listed drug product patent expiration.
Feb 06, 2038
in 11 yr 10 mo
Patent 11173209 expires
Listed method-of-use patent (U-3979) expiration.
Feb 06, 2038
in 11 yr 10 mo
Patent 10682414 expires
Listed method-of-use patent (U-3979) expiration.
Feb 06, 2039
in 12 yr 10 mo
Patent 11191838 expires
Listed drug product patent expiration.
Feb 06, 2039
in 12 yr 10 mo
Patent 11717571 expires
Listed method-of-use patent (U-3979) expiration.
Feb 06, 2039
in 12 yr 10 mo
Patent 11744895 expires
Listed method-of-use patent (U-3979) expiration.
Feb 06, 2039
in 12 yr 10 mo
Patent 11918655 expires
Listed method-of-use patent (U-3979) expiration.
Feb 06, 2039
in 12 yr 10 mo
Patent 12324838 expires
Listed drug product patent expiration.
Feb 06, 2039
in 12 yr 10 mo
Pharmaceutical detail
Active ingredient
EPINEPHRINE
Strength
1MG/SPRAY
Dosage form
SPRAY
Route
NASAL
TE code
Not listed
Application
NDA 214697
Product number
002
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.
- 2026EPINEPHRINEBrand (NDA)
NDA 220626 · BAXTER HLTHCARE CORP
- 2025EPINEPHRINEBrand (NDA)
NDA 215425 · FRESENIUS KABI USA
- 2024EPINEPHRINEBrand (NDA)
NDA 205029 · BPI LABS
- 2023ADRENALINBrand (NDA)
NDA 215875 · PH HEALTH
- 2022EPINEPHRINEBrand (NDA)
NDA 211363 · INTL MEDICATION SYS
- 2019EPINEPHRINEBrand (NDA)
NDA 209359 · HOSPIRA
- 2018PRIMATENE MISTBrand (NDA)
NDA 205920 · ARMSTRONG PHARMS
- 2018SYMJEPIBrand (NDA)
NDA 207534 · ADAMIS PHARMS CORP
- 2017AUVI-QBrand (NDA)
NDA 201739 · KALEO INC
- 2013ADRENALINBrand (NDA)
NDA 204640 · PH HEALTH
- 2012ADRENALINBrand (NDA)
NDA 204200 · PH HEALTH
- 2009ADRENACLICKBrand (NDA)
NDA 020800 · IMPAX
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10576156 | Feb 06, 2038 | in 11 yr 10 mo | Product |
| 11173209 | Feb 06, 2038 | in 11 yr 10 mo | U-3979 |
| 10682414 | Feb 06, 2039 | in 12 yr 10 mo | U-3979 |
| 11191838 | Feb 06, 2039 | in 12 yr 10 mo | ProductU-3979 |
| 11717571 | Feb 06, 2039 | in 12 yr 10 mo | U-3979 |
| 11744895 | Feb 06, 2039 | in 12 yr 10 mo | U-3979 |
| 11918655 | Feb 06, 2039 | in 12 yr 10 mo | U-3979 |
| 12324838 | Feb 06, 2039 | in 12 yr 10 mo | Product |
