FDA Orange Book · active-ingredient family
Alcaftadine
Alcaftadine: 1 brand, 3 generics; first approved Jul 28, 2010; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
2
Next patent expiry
Mar 19, 2027
in 7 mo
Brand (NDA) products
Originator applications
- ABBVIENDA 0221342010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION/DROPS OPHTHALMIC OTC —
Generic (ANDA) products (3)
Abbreviated applications
- ALCAFTADINEALEMBICANDA 2092902024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION/DROPS OPHTHALMIC OTC — - ALCAFTADINEGLANDANDA 2097062024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION/DROPS OPHTHALMIC OTC — - ALCAFTADINEEUGIA PHARMAANDA 2106592023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION/DROPS OPHTHALMIC Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10617695 | in 7 mo | ProductU-3267 | |
| 8664215 | in 1 yr 5 mo | U-3267 |
Approval history
FDA approval span
First approval
16 yr 3 mo ago
Most recent approval
1 yr 11 mo ago
Approvals span 2010–2024 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Alcaftadine: 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.
