FDA Orange Book · active-ingredient family
Phenylephrine hydrochloride
Phenylephrine hydrochloride is approved as 6 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE · NDA 216830
6
Brand (NDA)
26
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDERLD | DR REDDYS LABS SA | NDA 216830 | — | May 30, 2025 | |
| IMMPHENTIVRLD×5 | HIKMA | NDA 203826 | — | Mar 09, 2023 | |
| BIORPHENRLD×2 | DR REDDYS LABS SA | NDA 212909 | AP | Oct 21, 2019 | |
| PHENYLEPHRINE HYDROCHLORIDERLD×2 | ALCON | NDA 207926 | AT | Jan 15, 2015 | |
| VAZCULEPRLD×3 | EXELA PHARMA | NDA 204300 | — | Jun 27, 2014 | |
| PHENYLEPHRINE HYDROCHLORIDERLD×2 | PARAGON BIOTECK | NDA 203510 | AT | Mar 21, 2013 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE×3 | BAXTER HLTHCARE CORP | ANDA 217032 | AP1 | Apr 03, 2026 | |
| PHENYLEPHRINE HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 215617 | AP | Feb 14, 2025 | |
| PHENYLEPHRINE HYDROCHLORIDE×2 | GLAND | ANDA 218129 | AT | Dec 18, 2024 | |
| PHENYLEPHRINE HYDROCHLORIDE×2 | CAPLIN | ANDA 215183 | AT | May 23, 2024 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | ASPIRO | ANDA 218110 | AP1 | May 10, 2024 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | HAINAN POLY | ANDA 218412 | AP1 | Mar 14, 2024 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | BE PHARMS | ANDA 217521 | AP2 | Jun 26, 2023 | |
| PHENYLEPHRINE HYDROCHLORIDE | AVET LIFESCIENCES | ANDA 209968 | AP2 | Feb 28, 2023 | |
| PHENYLEPHRINE HYDROCHLORIDE | MANKIND PHARMA | ANDA 216496 | AT | Jan 11, 2023 | |
| PHENYLEPHRINE HYDROCHLORIDE | MANKIND PHARMA | ANDA 216859 | AT | Sep 29, 2022 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | MANKIND PHARMA | ANDA 217069 | AP1 | Aug 30, 2022 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | GLAND | ANDA 211920 | AP1 | Apr 08, 2021 | |
| PHENYLEPHRINE HYDROCHLORIDE | EUGIA PHARMA | ANDA 210696 | AP2 | Jan 07, 2021 | |
| PHENYLEPHRINE HYDROCHLORIDE×2 | EUGIA PHARMA | ANDA 210697 | AP1 | Nov 13, 2020 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | MILLA PHARMS | ANDA 211081 | AP1 | Jul 17, 2020 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | ACCORD HLTHCARE | ANDA 213237 | — | Jul 01, 2020 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | CAPLIN | ANDA 213318 | AP1 | Jun 11, 2020 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | SAGENT PHARMS INC | ANDA 209967 | AP1 | Jan 16, 2020 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | SANDOZ | ANDA 208905 | AP1 | Jan 31, 2019 | |
| PHENYLEPHRINE HYDROCHLORIDE×2 | FRESENIUS KABI USA | ANDA 210666 | AP1 | Jan 30, 2019 | |
| PHENYLEPHRINE HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 210665 | AP2 | Jan 29, 2019 | |
| PHENYLEPHRINE HYDROCHLORIDE×3 | PH HEALTH | ANDA 210025 | — | Dec 21, 2018 | |
| PHENYLEPHRINE HYDROCHLORIDE×2 | AMNEAL | ANDA 211078 | AP1 | Jul 19, 2018 | |
| PHENYLEPHRINE HYDROCHLORIDE | AMNEAL | ANDA 211079 | AP1 | Jul 05, 2018 | |
| PHENYLEPHRINE HYDROCHLORIDE | MEITHEAL | ANDA 210334 | AP2 | Apr 27, 2018 | |
| PHENYLEPHRINE HYDROCHLORIDE×2 | MEITHEAL | ANDA 210333 | AP1 | Apr 27, 2018 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8859623 | Nov 14, 2033 | in 7 yr 6 mo | U-1594 |
| 11471400 | Aug 05, 2036 | in 10 yr 3 mo | Product |
| 11213480 | Sep 26, 2036 | in 10 yr 5 mo | Product |
| 12257342 | Sep 26, 2036 | in 10 yr 5 mo | Product |
| 12564561 | Aug 08, 2044 | in 18 yr 5 mo | Product |
Phenylephrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
