GLYCOPYRRONIUM TOSYLATE - Generic Drug Details

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What are the generic 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

Generic Entry Date for GLYCOPYRRONIUM TOSYLATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for GLYCOPYRRONIUM TOSYLATE

D11AA	Antihidrotics
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

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Glossary

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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			⤷ 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

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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

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Country	Patent Number	Title	Estimated Expiration
Canada	2702830	FORMULATIONS TOPIQUES DE GLYCOPYRROLATE (TOPICAL GLYCOPYRROLATE FORMULATIONS)	⤷ Sign Up
Spain	2969237		⤷ Sign Up
Canada	2702830		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for GLYCOPYRRONIUM TOSYLATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	92393	Luxembourg	⤷ Sign Up	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
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
>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.