FDA Orange Book · active-ingredient family
Ephedrine sulfate
Ephedrine sulfate is approved as 5 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EMERPHED · NDA 213407
5
Brand (NDA)
17
Generics (ANDA)
7
Listed patents
2
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EMERPHEDRLD×2 | NEXUS | NDA 213407 | — | Feb 28, 2023 | |
| EPHEDRINE SULFATERLD×2 | PH HEALTH | NDA 213994 | AP2 | Apr 22, 2022 | |
| AKOVAZRLD×2 | EXELA PHARMA | NDA 208289 | AP3 | Aug 02, 2021 | |
| EPHEDRINE SULFATE | RENEW PHARMS | NDA 208609 | — | Mar 01, 2017 | |
| CORPHEDRA | PH HEALTH | NDA 208943 | AP | Jan 27, 2017 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPHEDRINE SULFATE | FRESENIUS KABI USA | ANDA 219991 | AP2 | Mar 19, 2026 | |
| EPHEDRINE SULFATE | CIVICA | ANDA 215593 | AP | Dec 23, 2025 | |
| EPHEDRINE SULFATE×2 | FRESENIUS KABI USA | ANDA 218271 | AP2 | Mar 11, 2025 | |
| EPHEDRINE SULFATE | GLAND | ANDA 218211 | AP1 | Jan 16, 2025 | |
| EPHEDRINE SULFATE | HIKMA | ANDA 217721 | AP3 | Oct 11, 2024 | |
| EPHEDRINE SULFATE | CAPLIN | ANDA 219050 | AP | Jul 18, 2024 | |
| EPHEDRINE SULFATE | ZYDUS PHARMS | ANDA 217276 | — | May 16, 2023 | |
| EPHEDRINE SULFATE | SAGENT PHARMS INC | ANDA 214528 | AP | Mar 09, 2023 | |
| EPHEDRINE SULFATE | XIROMED | ANDA 215825 | AP | Apr 21, 2022 | |
| EPHEDRINE SULFATE | MANKIND PHARMA | ANDA 216129 | AP | Apr 14, 2022 | |
| EPHEDRINE SULFATE | GLAND | ANDA 216146 | AP | Feb 25, 2022 | |
| EPHEDRINE SULFATE | EUGIA PHARMA | ANDA 214579 | AP | Jun 14, 2021 | |
| EPHEDRINE SULFATE | HIKMA | ANDA 214334 | AP | Dec 15, 2020 | |
| EPHEDRINE SULFATE | DR REDDYS | ANDA 212649 | AP | Oct 03, 2020 | |
| EPHEDRINE SULFATE | FRESENIUS KABI USA | ANDA 209646 | AP | Aug 04, 2020 | |
| EPHEDRINE SULFATE | AMNEAL | ANDA 212932 | AP | Oct 23, 2019 | |
| EPHEDRINE SULFATE | SANDOZ | ANDA 209784 | AP | Aug 23, 2017 |
Marketing exclusivity (2)
- PCPatent-challenge (180-day generic) exclusivity
Feb 21, 2026
4 mo ago
- PCPatent-challenge (180-day generic) exclusivity
Feb 21, 2026
4 mo ago
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12029710 | Jan 22, 2040 | in 13 yr 10 mo | U-3963 |
| 10869845 | Jan 22, 2040 | in 13 yr 10 mo | Product |
| 11571398 | May 16, 2040 | in 14 yr 1 mo | U-3183 |
| 11464752 | May 16, 2040 | in 14 yr 1 mo | Product |
| 11478436 | May 16, 2040 | in 14 yr 1 mo | U-3183 |
| 11090278 | May 16, 2040 | in 14 yr 1 mo | U-3183 |
| 11241400 | May 16, 2040 | in 14 yr 1 mo | U-3183 |
Ephedrine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
