Is there a generic for Glycopyrronium tosylate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Glycopyrronium tosylate, referencing the brand QBREXZA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Glycopyrronium tosylate?

QBREXZA (NDA 210361, JOURNEY) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Glycopyrronium tosylate?

The Orange Book lists 8 patents against Glycopyrronium tosylate products, with the earliest listed expiry in 2028. 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.

What dosage forms of Glycopyrronium tosylate are approved?

Glycopyrronium tosylate is approved in the following dosage form: cloth.

FDA Orange Book · active-ingredient family

Glycopyrronium tosylate

Glycopyrronium tosylate: 1 brand, 1 generic; first approved Jun 28, 2018; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Oct 17, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 17, 2028

in 2 yr 1 mo

Brand (NDA) products

Originator applications

QBREXZARLDRS
JOURNEYNDA 2103612018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.4% BASE CLOTH TOPICAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.4% BASE	CLOTH	TOPICAL	Rx	—

Generic (ANDA) products (1)

Abbreviated applications

GLYCOPYRRONIUM TOSYLATE
PADAGIS USANDA 2144482026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.4% BASE CLOTH TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.4% BASE	CLOTH	TOPICAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10052267	Oct 17, 2028	in 2 yr 1 mo	ProductU-2398
8618160	Dec 10, 2029	in 3 yr 3 mo	ProductU-2398
9744105	Jul 18, 2030	in 3 yr 10 mo	ProductU-2398
8859610	Feb 28, 2033	in 6 yr 6 mo	ProductU-2398
9259414	Feb 28, 2033	in 6 yr 6 mo	U-2398
10004717	Feb 28, 2033	in 6 yr 6 mo	ProductU-2398
10548875	Feb 28, 2033	in 6 yr 6 mo	SubstanceProductU-2398
10543192	Feb 28, 2033	in 6 yr 6 mo	Product

Approval history

FDA approval span

First approval

Jun 28, 2018

8 yr 5 mo ago

Most recent approval

Apr 03, 2026

6 mo ago

Approvals span 2018–2026 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Glycopyrronium tosylate: 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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