FDA Orange Book · active-ingredient family
Eletriptan hydrobromide
Eletriptan hydrobromide: 1 brand, 9 generics; first approved Dec 26, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- RELPAXRLDUPJOHNNDA 02101620022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (9)
Abbreviated applications
- ELETRIPTAN HYDROBROMIDEANNORA PHARMAANDA 21914320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - ELETRIPTAN HYDROBROMIDEREGCON HOLDINGSANDA 21546720222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - ELETRIPTAN HYDROBROMIDECARLSBADANDA 20968020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - ELETRIPTAN HYDROBROMIDEAUROBINDO PHARMAANDA 21070820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - ELETRIPTAN HYDROBROMIDESTEVENS JANDA 20678720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - ELETRIPTAN HYDROBROMIDECHARTWELL RXANDA 20518620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - ELETRIPTAN HYDROBROMIDEMYLANANDA 20515220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - ELETRIPTAN HYDROBROMIDETEVA PHARMS USAANDA 20204020172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - ELETRIPTAN HYDROBROMIDEZYDUS PHARMSANDA 20640920172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
24 yr ago
Most recent approval
1 yr 2 mo ago
Approvals span 2002–2025 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Eletriptan hydrobromide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
