GLYCOPYRRONIUM TOSYLATE - Generic Drug Details

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-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

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			Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes			Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes			Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes			Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes			Y

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

International Patents for GLYCOPYRRONIUM TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Mexico	2020002544	SALES DE GLICOPIRROLATO. (GLYCOPYRROLATE SALTS.)
Mexico	2010004262	FORMULACIONES TOPICAS DE GLICOPIRROLATO. (TOPICAL GLYCOPYRROLATE FORMULATIONS.)
Australia	2014223172	Glycopyrrolate salts
European Patent Office	3842419	PROCÉDÉ POUR LA PREPARATION DU THREO GLYCOPYRROLATE TOSYLATE (METHOD OF MAKING THREO GLYCOPYRROLATE TOSYLATE)
Japan	6379246

Supplementary Protection Certificates for GLYCOPYRRONIUM TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	C300583	Netherlands		PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435024	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
1267866	CR 2013 00015	Denmark		PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003