FDA Orange Book · active-ingredient family
Alcaftadine
Alcaftadine is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LASTACAFT · NDA 022134
1
Brand (NDA)
3
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LASTACAFTRLD | ABBVIE | NDA 022134 | — | Jul 28, 2010 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALCAFTADINE | ALEMBIC | ANDA 209290 | — | Oct 02, 2024 | |
| ALCAFTADINE | GLAND | ANDA 209706 | — | Mar 01, 2024 | |
| ALCAFTADINE | EUGIA PHARMA | ANDA 210659 | — | Jun 23, 2023 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10617695 | Mar 19, 2027 | in 9 mo | ProductU-3267 |
| 8664215 | Dec 23, 2027 | in 1 yr 6 mo | U-3267 |
Alcaftadine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
