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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
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 |
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
| Sponsor | Phase |
|---|---|
| Therapeutics, Inc. | Phase 2 |
| Dr. August Wolff GmbH & Co. KG Arzneimittel | Phase 2 |
Pharmacology for QBREXZA
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic 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 |
International Patents for QBREXZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2010004262 | Start Trial |
| Canada | 2902795 | Start Trial |
| Hong Kong | 1212350 | Start Trial |
| South Korea | 20160081989 | Start Trial |
| Australia | 2014223172 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2014134510 | Start Trial |
| Mexico | 2015011228 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
