FDA Orange Book · active-ingredient family
Latanoprost
Latanoprost is approved as 3 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IYUZEH · NDA 216472
3
Brand (NDA)
12
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · emulsion, solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IYUZEHRLD | THEA PHARMA | NDA 216472 | — | Dec 13, 2022 | |
| XELPROSRLD | SUN PHARM | NDA 206185 | — | Sep 12, 2018 | |
| XALATANRLD | UPJOHN | NDA 020597 | AT | Jun 05, 1996 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LATANOPROST | MANKIND PHARMA | ANDA 220360 | AT | Dec 17, 2025 | |
| LATANOPROST | MICRO LABS | ANDA 219306 | AT | Apr 14, 2025 | |
| LATANOPROST | GLAND | ANDA 218257 | AT | Nov 26, 2024 | |
| LATANOPROST | EUGIA PHARMA | ANDA 206519 | — | Sep 03, 2019 | |
| LATANOPROST | FDC LTD | ANDA 202442 | AT | Apr 22, 2016 | |
| LATANOPROST | CARNEGIE | ANDA 202077 | — | Feb 11, 2013 | |
| LATANOPROST | EPIC PHARMA LLC | ANDA 090887 | — | Jul 19, 2011 | |
| LATANOPROST | AMRING PHARMS | ANDA 200925 | AT | Mar 22, 2011 | |
| LATANOPROST | APOTEX INC | ANDA 077697 | — | Mar 22, 2011 | |
| LATANOPROST | BAUSCH AND LOMB | ANDA 201006 | AT | Mar 22, 2011 | |
| LATANOPROST | SANDOZ | ANDA 091449 | AT | Mar 22, 2011 | |
| LATANOPROST | SOMERSET | ANDA 201786 | AT | Mar 22, 2011 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9539262 | Oct 15, 2028 | in 2 yr 4 mo | U-2400 |
| 9629852 | Sep 12, 2029 | in 3 yr 3 mo | Product |
| 8637054 | Jul 08, 2031 | in 5 yr 2 mo | ProductU-446 |
Latanoprost — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
