FDA Orange Book · active-ingredient family
Latanoprost
Latanoprost: 3 brands, 12 generics; first approved Jun 05, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
12
Listed patents
3
Next patent expiry
Oct 15, 2028
in 2 yr 1 mo
Brand (NDA) products
Originator applications
- THEA PHARMANDA 2164722022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx — - XELPROSRLDSUN PHARMNDA 2061852018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% EMULSION OPHTHALMIC Discontinued — - UPJOHNNDA 0205971996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx AT
Generic (ANDA) products (12)
Abbreviated applications
- LATANOPROSTMANKIND PHARMAANDA 2203602025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Discontinued — - LATANOPROSTMICRO LABSANDA 2193062025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx AT - LATANOPROSTGLANDANDA 2182572024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx AT - LATANOPROSTEUGIA PHARMAANDA 2065192019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Discontinued — - LATANOPROSTFDC LTDANDA 2024422016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx AT - LATANOPROSTCARNEGIEANDA 2020772013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Discontinued — - LATANOPROSTEPIC PHARMA LLCANDA 0908872011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Discontinued — - LATANOPROSTAPOTEX INCANDA 0776972011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Discontinued — - LATANOPROSTBAUSCH AND LOMBANDA 2010062011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx AT - LATANOPROSTJ MOLNERANDA 2009252011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx AT - LATANOPROSTSANDOZANDA 0914492011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx AT - LATANOPROSTSOMERSETANDA 2017862011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION/DROPS OPHTHALMIC Rx AT
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9539262 | in 2 yr 1 mo | U-2400 | |
| 9629852 | in 3 yr | Product | |
| 8637054 | in 4 yr 10 mo | ProductU-446 |
Approval history
FDA approval span
First approval
30 yr 9 mo ago
Most recent approval
10 mo ago
Approvals span 1996–2025 across 15 FDA applications.
Brand (NDA) 320%
Generic (ANDA) 1280%
Latanoprost: 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.
