Orange Book product · Brand (NDA)

IDOSE TR

TRAVOPROST

Brand (NDA)NDA 218010RX GLAUKOS

Dec 13, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 13, 2023
2 yr 7 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Dec 13, 2026
in 6 mo
Patent 12201557 expires
Listed drug substance patent expiration.
Jun 18, 2030
in 4 yr 1 mo
Patent 10206813 expires
Listed drug product patent expiration.
Oct 17, 2030
in 4 yr 5 mo
Patent 11426306 expires
Listed drug product patent expiration.
Oct 17, 2030
in 4 yr 5 mo
Patent 12201555 expires
Listed drug substance patent expiration.
Feb 14, 2031
in 4 yr 9 mo

Active ingredient

TRAVOPROST

Strength

75MCG

Dosage form

IMPLANT

Route

INTRACAMERAL

TE code

Not listed

Application

NDA 218010

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12201557	Jun 18, 2030	in 4 yr 1 mo	SubstanceProductU-4129
10206813	Oct 17, 2030	in 4 yr 5 mo	Product
11426306	Oct 17, 2030	in 4 yr 5 mo	Product
12201555	Feb 14, 2031	in 4 yr 9 mo	SubstanceProduct