Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Dow
McKinsey
Colorcon
Boehringer Ingelheim

Last Updated: May 21, 2022

Details for New Drug Application (NDA): 210361


✉ Email this page to a colleague

« Back to Dashboard

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 Generic Entry Opportunity Date for 210361
Generic Entry Date for 210361*:
Constraining patent/regulatory exclusivity:
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
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 69489-411-30 30 POUCH in 1 CARTON (69489-411-30) > 2.8 g in 1 POUCH (69489-411-01)
QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361 NDA Journey Medical Corporation 70428-011 70428-011-12 30 POUCH in 1 CARTON (70428-011-12) > 2.8 g in 1 POUCH (70428-011-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CLOTH;TOPICALStrengthEQ 2.4% BASE
Approval Date:Jun 28, 2018TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Feb 28, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Patent:See Plans and PricingPatent Expiration:Oct 17, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Patent:See Plans and PricingPatent Expiration:Feb 28, 2033Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Harvard Business School
Dow
McKinsey
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.