FDA Orange Book · active-ingredient family
Epinastine hydrochloride
Epinastine hydrochloride: 1 brand, 6 generics; first approved Oct 16, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- ELESTATRLDALLERGANNDA 0215652003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- EPINASTINE HYDROCHLORIDEEPIC PHARMA LLCANDA 2040552017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued — - EPINASTINE HYDROCHLORIDECHARTWELL RXANDA 2033842016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued — - EPINASTINE HYDROCHLORIDEAPOTEXANDA 0909192011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued — - EPINASTINE HYDROCHLORIDERSSOMERSET THERAPS LLCANDA 0909512011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Rx — - EPINASTINE HYDROCHLORIDESUN PHARM INDSANDA 0916262011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued — - EPINASTINE HYDROCHLORIDEPHARMOBEDIENTANDA 0908702011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% SOLUTION/DROPS OPHTHALMIC Discontinued —
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
23 yr 2 mo ago
Most recent approval
9 yr 5 mo ago
Approvals span 2003–2017 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Epinastine hydrochloride: 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.
