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QBREXZA Drug Profile
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» See Plans and PricingWhich patents cover Qbrexza, and when can generic versions of Qbrexza launch?
Qbrexza is a drug marketed by Dermira Inc and is included in one NDA. There are nine 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
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: | 9 |
| 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 |
|---|---|
| Dr. August Wolff GmbH & Co. KG Arzneimittel | Phase 2 |
| Therapeutics, Inc. | 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 | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for QBREXZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Dermira Inc | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for QBREXZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2016510037 | Start Trial |
| European Patent Office | 2961734 | Start Trial |
| Japan | 2017128593 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for QBREXZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1267866 | 92393 | Luxembourg | Start Trial | PRODUCT NAME: GLYCOPYRRONIUM OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL BROMURE, COMBINE A INDACATEROL OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL MALEATE. FIRST REGISTRATION: 20130923 |
| 1267866 | CR 2013 00015 | Denmark | Start Trial | PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003 |
| 1267866 | SPC/GB13/020 | United Kingdom | Start Trial | PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTERED: UK EU/1/12/788/001 20120928; UK EU/1/12/788/002 20120928; UK EU/1/12/788/003 20120928; UK EU/1/12/788/004 20120928; UK EU/1/12/788/005 20120928; UK EU/1/12/788/006 20120928 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
