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FDA Orange Book · active-ingredient family

Latanoprost; netarsudil dimesylate

Latanoprost; netarsudil dimesylate: 1 brand, 0 generics; first approved Mar 12, 2019; on patent until Jul 11, 2026.

On patent
Generic status & protection

Protected until Jul 11, 2026 (earliest listed patent expiry).

Earliest patent expiry Jul 11, 2026
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
17
Next patent expiry
Jul 11, 2026
2 d ago
Originator applications

Brand (NDA) products

ROCKLATANRLDRS
NDA 2082592019
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.005%;EQ 0.02% BASESOLUTION/DROPSOPHTHALMICRx—
Protection horizon

Patent & exclusivity timeline

2026202720282029203020312032203320342035TodayPatent 9096569 — 2026-07-11Patent 9096569Patent 8450344 — 2026-07-11Patent 8450344Patent 10882840 — 2026-07-11Patent 10882840Patent 10532993 — 2026-07-11Patent 10532993Patent 11021456 — 2026-07-11Patent 11021456Patent 10174017 — 2030-01-27Patent 10174017Patent 11618748 — 2030-01-27Patent 11618748Patent 10654844 — 2030-01-27Patent 10654844Patent 11028081 — 2030-01-27Patent 11028081Patent 8394826 — 2030-11-10Patent 8394826Patent 9993470 — 2034-03-14Patent 9993470Patent 9931336 — 2034-03-14Patent 9931336Patent 10588901 — 2034-03-14Patent 10588901Patent 11020385 — 2034-03-14Patent 11020385Patent 11185538 — 2034-03-14Patent 11185538Patent 11197853 — 2034-03-14Patent 11197853Patent 9415043 — 2034-03-14Patent 9415043
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (17)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9096569Jul 11, 20262 d ago
SubstanceProductU-1524
8450344Jul 11, 20262 d ago
SubstanceProductU-1524
10882840Jul 11, 20262 d ago
U-1524
10532993Jul 11, 20262 d ago
U-1524
11021456Jul 11, 20262 d ago
U-1524
10174017Jan 27, 2030in 3 yr 7 mo
SubstanceProductU-1524
11618748Jan 27, 2030in 3 yr 7 mo
U-1524
10654844Jan 27, 2030in 3 yr 7 mo
SubstanceProductU-1524
11028081Jan 27, 2030in 3 yr 7 mo
U-1524
8394826Nov 10, 2030in 4 yr 5 mo
SubstanceProductU-1524
9993470Mar 14, 2034in 7 yr 9 mo
SubstanceProductU-1524
9931336Mar 14, 2034in 7 yr 9 mo
SubstanceProductU-1524
10588901Mar 14, 2034in 7 yr 9 mo
SubstanceProductU-1524
11020385Mar 14, 2034in 7 yr 9 mo
U-1524
11185538Mar 14, 2034in 7 yr 9 mo
Product
11197853Mar 14, 2034in 7 yr 9 mo
Product
9415043Mar 14, 2034in 7 yr 9 mo
Substance
FDA approval span

Approval history

First approval
Mar 12, 2019
7 yr 5 mo ago
Most recent approval
Mar 12, 2019
7 yr 5 mo ago

All 1 application were approved in 2019.

Brand (NDA) 1100%
Generic (ANDA) 00%

Latanoprost; netarsudil dimesylate — 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.

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