Question 1

Is there a generic for Pilocarpine hydrochloride?

Accepted Answer

Yes. The FDA Orange Book lists 10 approved generic (ANDA) applications for Pilocarpine hydrochloride, referencing the brand QLOSI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Pilocarpine hydrochloride?

Accepted Answer

QLOSI (NDA 217836, ORASIS PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Pilocarpine hydrochloride?

Accepted Answer

The Orange Book lists 6 patents against Pilocarpine hydrochloride products, with the earliest listed expiry in 2037. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Pilocarpine hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Pilocarpine hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Pilocarpine hydrochloride are approved?

Accepted Answer

Pilocarpine hydrochloride is approved in the following dosage forms: gel, solution/drops, tablet.

Product	Applicant	Application	TE	Approved
QLOSIRLD	ORASIS PHARMS	NDA 217836	—	Oct 17, 2023
VUITYRLD	ABBVIE	NDA 214028	—	Oct 28, 2021
ISOPTO CARPINERLD×3	SANDOZ	NDA 200890	AT	Jun 22, 2010
SALAGENRLD×2	ADVANZ PHARMA	NDA 020237	AB	Mar 22, 1994
PILOPINE HS	ALCON	NDA 018796	—	Oct 01, 1984

Product	Applicant	Application	TE	Approved
PILOCARPINE HYDROCHLORIDE×3	FDC LTD	ANDA 217052	—	Oct 02, 2025
PILOCARPINE HYDROCHLORIDE	AMNEAL	ANDA 217733	—	Apr 28, 2025
PILOCARPINE HYDROCHLORIDE×3	AMNEAL	ANDA 214193	AT	Sep 21, 2020
PILOCARPINE HYDROCHLORIDE×3	SOMERSET THERAPS LLC	ANDA 210384	AT	Nov 25, 2019
PILOCARPINE HYDROCHLORIDE×2	AUROBINDO PHARMA USA	ANDA 212377	AB	Aug 13, 2019
PILOCARPINE HYDROCHLORIDE×3	RISING	ANDA 204398	AT	Sep 27, 2017
PILOCARPINE HYDROCHLORIDE×2	IMPAX LABS	ANDA 077248	AB	Mar 31, 2006
PILOCARPINE HYDROCHLORIDE×2	LANNETT CO INC	ANDA 077220	AB	Oct 14, 2005
PILOCARPINE HYDROCHLORIDE×2	INNOGENIX	ANDA 076963	AB	Dec 22, 2004
PILOCARPINE HYDROCHLORIDE	PADAGIS US	ANDA 076746	—	Nov 16, 2004

Patent	Expires	In	Type
11129812	Aug 18, 2037	in 11 yr 4 mo	U-3741
10639297	Aug 18, 2037	in 11 yr 4 mo	ProductU-3741
11974986	Aug 18, 2037	in 11 yr 4 mo	U-3741
9867810	Aug 18, 2037	in 11 yr 4 mo	ProductU-3741
10610518	Apr 24, 2039	in 13 yr	U-3562
11285134	Apr 24, 2039	in 13 yr	U-3561

Pilocarpine hydrochloride

Brand (NDA) products · gel, solution/drops, tablet

Generic (ANDA) products (10)

Marketing exclusivity (2)

Listed patents (6)

Pilocarpine hydrochloride — frequently asked questions

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