Question 1

Is there a generic for Glycopyrronium tosylate?

Accepted Answer

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.

Question 2

What is the reference-listed drug for Glycopyrronium tosylate?

Accepted Answer

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

Question 3

What patents protect Glycopyrronium tosylate?

Accepted Answer

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.

Question 4

What dosage forms of Glycopyrronium tosylate are approved?

Accepted Answer

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

Patent	Expires	In	Type
10052267	Oct 17, 2028	in 2 yr 4 mo	ProductU-2398
8618160	Dec 10, 2029	in 3 yr 6 mo	ProductU-2398
9744105	Jul 18, 2030	in 4 yr 2 mo	ProductU-2398
8859610	Feb 28, 2033	in 6 yr 10 mo	ProductU-2398
9259414	Feb 28, 2033	in 6 yr 10 mo	U-2398
10004717	Feb 28, 2033	in 6 yr 10 mo	ProductU-2398
10548875	Feb 28, 2033	in 6 yr 10 mo	SubstanceProductU-2398
10543192	Feb 28, 2033	in 6 yr 10 mo	Product

Glycopyrronium tosylate

Brand (NDA) products · cloth

Generic (ANDA) products (1)

Listed patents (8)

Glycopyrronium tosylate — frequently asked questions

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