Details for New Drug Application (NDA): 210361

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NDA 210361 describes QBREXZA, which is a drug marketed by Journey and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the QBREXZA profile page.

The generic ingredient in QBREXZA is glycopyrronium tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrronium tosylate profile page.

Summary for 210361

Tradename:	QBREXZA
Applicant:	Journey
Ingredient:	glycopyrronium tosylate
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210361

Generic Entry Date for 210361^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,859,610 Dosage: CLOTH;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 210361

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 210361

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361	NDA	Journey Medical Corporation	69489-411	69489-411-05	5 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51)
QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361	NDA	Journey Medical Corporation	69489-411	69489-411-30	30 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CLOTH;TOPICAL			Strength	EQ 2.4% BASE
Approval Date:	Jun 28, 2018	TE:		RLD:	Yes
Patent:	10,004,717	Patent Expiration:	Feb 28, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Patent:	10,052,267	Patent Expiration:	Oct 17, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Patent:	10,543,192	Patent Expiration:	Feb 28, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 210361

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018	6,433,003	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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