Glycopyrronium tosylate - Generic Drug Details
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What are the generic drug sources for glycopyrronium tosylate and what is the scope of freedom to operate?
Glycopyrronium tosylate
is the generic ingredient in one branded drug marketed by Journey and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Glycopyrronium tosylate has thirty-six patent family members in thirteen countries.
One supplier is listed for this compound.
Summary for glycopyrronium tosylate
| International Patents: | 36 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 16 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for glycopyrronium tosylate |
| DailyMed Link: | glycopyrronium tosylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for glycopyrronium tosylate
*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 glycopyrronium tosylate
| Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for glycopyrronium tosylate
Paragraph IV (Patent) Challenges for GLYCOPYRRONIUM TOSYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| QBREXZA | Topical Cloth | glycopyrronium tosylate | 2.4% | 210361 | 1 | 2020-01-13 |
US Patents and Regulatory Information for glycopyrronium tosylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 glycopyrronium tosylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for glycopyrronium tosylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2008314628 | Topical glycopyrrolate formulations | ⤷ Sign Up |
| Hong Kong | 1212350 | 格隆鈉鹽 (GLYCOPYRROLATE SALTS) | ⤷ Sign Up |
| South Korea | 20150119468 | 글리코피롤레이트 염 (GLYCOPYRROLATE SALTS) | ⤷ Sign Up |
| European Patent Office | 3415127 | FORMULATIONS TOPIQUES DE GLYCOPYRROLATE ET LINGETTE LES CONTENANT (TOPICAL GLYCOPYRROLATE FORMULATIONS AND A WIPE CONTAINING THEREOF) | ⤷ Sign Up |
| Canada | 2702830 | FORMULATIONS TOPIQUES DE GLYCOPYRROLATE (TOPICAL GLYCOPYRROLATE FORMULATIONS) | ⤷ Sign Up |
| South Korea | 20190138676 | 글리코피롤레이트 염 (GLYCOPYRROLATE SALTS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for glycopyrronium tosylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435024 | LUC00208 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
| 2435024 | C02435024/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021 |
| 2435025 | 300995 | Netherlands | ⤷ Sign Up | 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 | 2013C/023 | Belgium | ⤷ Sign Up | PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/788/001 20121002 |
| 1267866 | C300583 | Netherlands | ⤷ Sign Up | PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
| 1267866 | SPC/GB13/020 | United Kingdom | ⤷ Sign Up | 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 |
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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.
ISSN: 2162-2639
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