Orange Book product · Brand (NDA)

QLOSI

PILOCARPINE HYDROCHLORIDE

Brand (NDA)NDA 217836RX ORASIS PHARMS

Oct 17, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 17, 2023
2 yr 9 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 17, 2026
in 4 mo
Patent 10639297 expires
Listed drug product patent expiration.
Aug 18, 2037
in 11 yr 4 mo
Patent 11129812 expires
Listed method-of-use patent (U-3741) expiration.
Aug 18, 2037
in 11 yr 4 mo
Patent 11974986 expires
Listed method-of-use patent (U-3741) expiration.
Aug 18, 2037
in 11 yr 4 mo
Patent 9867810 expires
Listed drug product patent expiration.
Aug 18, 2037
in 11 yr 4 mo

Active ingredient

PILOCARPINE HYDROCHLORIDE

Strength

0.4%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 217836

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
10639297	Aug 18, 2037	in 11 yr 4 mo	ProductU-3741
11129812	Aug 18, 2037	in 11 yr 4 mo	U-3741
11974986	Aug 18, 2037	in 11 yr 4 mo	U-3741
9867810	Aug 18, 2037	in 11 yr 4 mo	ProductU-3741