FDA Orange Book · active-ingredient family
Eletriptan hydrobromide
Eletriptan hydrobromide is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RELPAX · NDA 021016
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RELPAXRLD×2 | UPJOHN | NDA 021016 | AB | Dec 26, 2002 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ELETRIPTAN HYDROBROMIDE×2 | ANNORA PHARMA | ANDA 219143 | AB | Jul 07, 2025 | |
| ELETRIPTAN HYDROBROMIDE×2 | REGCON HOLDINGS | ANDA 215467 | AB | Jul 13, 2022 | |
| ELETRIPTAN HYDROBROMIDE×2 | CARLSBAD | ANDA 209680 | — | Jul 13, 2020 | |
| ELETRIPTAN HYDROBROMIDE×2 | AUROBINDO PHARMA | ANDA 210708 | AB | Jan 15, 2019 | |
| ELETRIPTAN HYDROBROMIDE×2 | STEVENS J | ANDA 206787 | — | May 25, 2018 | |
| ELETRIPTAN HYDROBROMIDE×2 | CHARTWELL RX | ANDA 205186 | AB | Aug 29, 2017 | |
| ELETRIPTAN HYDROBROMIDE×2 | MYLAN | ANDA 205152 | AB | Aug 11, 2017 | |
| ELETRIPTAN HYDROBROMIDE×2 | TEVA PHARMS USA | ANDA 202040 | AB | Jun 27, 2017 | |
| ELETRIPTAN HYDROBROMIDE×2 | ZYDUS PHARMS | ANDA 206409 | AB | Jun 16, 2017 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Eletriptan hydrobromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
