GLYCOPYRRONIUM TOSYLATE - Generic Drug Details
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What are the generic drug sources for glycopyrronium tosylate and what is the scope of patent protection?
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-four patent family members in thirteen countries.
One supplier is listed for this compound.
Summary for GLYCOPYRRONIUM TOSYLATE
| International Patents: | 34 |
| 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
Generic Entry Date for GLYCOPYRRONIUM TOSYLATE*:
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 GLYCOPYRRONIUM TOSYLATE
| Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GLYCOPYRRONIUM TOSYLATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2020002544 | SALES DE GLICOPIRROLATO. (GLYCOPYRROLATE SALTS.) | ⤷ Try a Trial |
| Singapore | 11201506789P | GLYCOPYRROLATE SALTS | ⤷ Try a Trial |
| Mexico | 2015011228 | SALES DE GLICOPIRROLATO. (GLYCOPYRROLATE SALTS.) | ⤷ Try a Trial |
| Japan | 6379246 | ⤷ Try a Trial | |
| South Korea | 20160081989 | 글리코피롤레이트 염 (GLYCOPYRROLATE SALTS) | ⤷ Try a Trial |
| Australia | 2008314628 | Topical glycopyrrolate formulations | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GLYCOPYRRONIUM TOSYLATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1267866 | 92393 | Luxembourg | ⤷ Try a 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 | 16/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM, GLYCOPYRRONIUMSALZ; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
| 1267866 | CR 2013 00015 | Denmark | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003 |
| 1267866 | 2013C/023 | Belgium | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/788/001 20121002 |
| 1267866 | 92166 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS |
| 1267866 | CA 2014 00020 | Denmark | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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