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

Brand (NDA) products

Originator applications

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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

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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

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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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	ProductU-2398
8618160	Dec 10, 2029	in 3 yr 2 mo	ProductU-2398
9744105	Jul 18, 2030	in 3 yr 9 mo	ProductU-2398
8859610	Feb 28, 2033	in 6 yr 5 mo	ProductU-2398
9259414	Feb 28, 2033	in 6 yr 5 mo	U-2398
10004717	Feb 28, 2033	in 6 yr 5 mo	ProductU-2398
10548875	Feb 28, 2033	in 6 yr 5 mo	SubstanceProductU-2398
10543192	Feb 28, 2033	in 6 yr 5 mo	Product

Approval history

FDA approval span

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First approval

Jun 28, 2018

8 yr 5 mo ago

Most recent approval

Apr 03, 2026

7 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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