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Last Updated: January 25, 2020

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QBREXZA Drug Profile

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Which patents cover Qbrexza, and what generic alternatives are available?

Qbrexza is a drug marketed by Dermira Inc and is included in one NDA. There are seven patents protecting this drug.

This drug has twenty-seven patent family members in twelve countries.

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.

US ANDA Litigation and Generic Entry Outlook for Qbrexza

Qbrexza was eligible for patent challenges on December 31, 1968.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for QBREXZA
International Patents:27
US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 1
Drug Prices: Drug price information for QBREXZA
DailyMed Link:QBREXZA at DailyMed
Drug patent expirations by year for QBREXZA
Drug Prices for QBREXZA

See drug prices for QBREXZA

Generic Entry Opportunity Date for QBREXZA
Generic Entry Date for QBREXZA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for QBREXZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Therapeutics, Inc.Phase 2
Dr. August Wolff GmbH & Co. KG ArzneimittelPhase 2

See all QBREXZA clinical trials

Pharmacology for QBREXZA
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

US Patents and Regulatory Information for QBREXZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for QBREXZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 300583 Netherlands   Start Trial PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE AFGELEIDEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
2435025 300995 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; REGISTRATION NO/DATE: EU/ 1/18/1339 20181220
1267866 C300583 Netherlands   Start Trial PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 122014000025 Germany   Start Trial PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919
2435025 36/2019 Austria   Start Trial PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
1267866 92166 Luxembourg   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS
1267866 2013/014 Ireland   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Mallinckrodt
McKesson
Moodys
Boehringer Ingelheim

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