FDA Orange Book · active-ingredient family
Fexofenadine hydrochloride
Fexofenadine hydrochloride: 5 brands, 19 generics; first approved Jul 25, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
19
Listed patents
1
Next patent expiry
Aug 02, 2030
in 4 yr
Brand (NDA) products
Originator applications
- CHATTEM SANOFINDA 20137320112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML SUSPENSION ORAL OTC — 30MG/5ML SUSPENSION ORAL Discontinued — - CHATTEM SANOFINDA 02190920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - CHATTEM SANOFINDA 02087220116 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL OTC — 60MG TABLET ORAL Discontinued — 180MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - ALLEGRARLDCHATTEM SANOFINDA 0219632006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML SUSPENSION ORAL Discontinued — - CHATTEM SANOFINDA 0206251996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (19)
Abbreviated applications
- FEXOFENADINE HYDROCHLORIDECONTRACT PHARMACALANDA 21903220252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - FEXOFENADINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2134662023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML SUSPENSION ORAL OTC — - FEXOFENADINE HYDROCHLORIDEL PERRIGO COANDA 21297120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - GRANULESANDA 21107520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - UNIQUEANDA 2101372018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 180MG TABLET ORAL OTC — - TAROANDA 20812320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML SUSPENSION ORAL OTC — 30MG/5ML SUSPENSION ORAL OTC — - HETERO LABS LTD VANDA 20409720163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL OTC — 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - SCIEGEN PHARMSANDA 20450720154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - AUROBINDO PHARMA LTDANDA 20203920143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL OTC — 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - P AND LANDA 20333020142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML SUSPENSION ORAL OTC — 30MG/5ML SUSPENSION ORAL OTC — - DR REDDYS LABS LTDANDA 20297820132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - FEXOFENADINE HYDROCHLORIDEP AND LANDA 2013112012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML SUSPENSION ORAL Discontinued — - TIME CAP LABSANDA 07911220126 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL OTC — 30MG TABLET ORAL OTC — 60MG TABLET ORAL OTC — 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - SUN PHARM INDSANDA 09156720126 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 180MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - RISINGANDA 07708120119 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 180MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — - TEVAANDA 07644720118 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — - DR REDDYS LABS LTDANDA 07650220119 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — 30MG TABLET ORAL OTC — 30MG TABLET ORAL OTC — 60MG TABLET ORAL OTC — 60MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — 180MG TABLET ORAL OTC — - FEXOFENADINE HYDROCHLORIDEBARRANDA 07619120053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — - FEXOFENADINE HYDROCHLORIDEBARRANDA 0761692005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8933097 | in 4 yr | Product |
Approval history
FDA approval span
First approval
30 yr 6 mo ago
Most recent approval
1 yr 6 mo ago
Approvals span 1996–2025 across 24 FDA applications.
Brand (NDA) 521%
Generic (ANDA) 1979%
Fexofenadine 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.
