FDA Orange Book · active-ingredient family
Ketotifen fumarate
Ketotifen fumarate is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACUVUE THERAVISION WITH KETOTIFEN · NDA 022388
3
Brand (NDA)
5
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · drug-eluting contact lens, solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACUVUE THERAVISION WITH KETOTIFENRLD | JOHNSON JOHNSON VISN | NDA 022388 | — | Feb 25, 2022 | |
| ALAWAYRLD×2 | BAUSCH AND LOMB | NDA 021996 | — | Dec 01, 2006 | |
| ZADITORRLD | ALCON PHARMA | NDA 021066 | — | Oct 19, 2006 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALAWAY | BAUSCH AND LOMB INC | ANDA 208158 | — | Sep 24, 2020 | |
| KETOTIFEN FUMARATE | UNICHEM | ANDA 204059 | — | Jun 01, 2020 | |
| ZADITOR | ALCON PHARMS LTD | ANDA 077200 | — | Sep 02, 2008 | |
| KETOTIFEN FUMARATE | SENTISS | ANDA 077958 | — | Jul 26, 2007 | |
| KETOTIFEN FUMARATE | APOTEX INC | ANDA 077354 | — | May 09, 2006 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9474746 | Mar 27, 2028 | in 1 yr 10 mo | Product |
| 9962376 | Jun 27, 2030 | in 4 yr 1 mo | Product |
Ketotifen fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
