XEGLYZE Drug Patent Profile

When do Xeglyze patents expire, and what generic alternatives are available?

Xeglyze is a drug marketed by Hatchtech and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-five patent family members in fifteen countries.

The generic ingredient in XEGLYZE is abametapir. One supplier is listed for this compound. Additional details are available on the abametapir profile page.

DrugPatentWatch^® Generic Entry Outlook for Xeglyze

Xeglyze will be eligible for patent challenges on July 31, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 17, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XEGLYZE

International Patents:	35
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	108
Patent Applications:	294
What excipients (inactive ingredients) are in XEGLYZE?	XEGLYZE excipients list
DailyMed Link:	XEGLYZE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XEGLYZE

NDA:

206966

Dosage:

LOTION;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.

Anatomical Therapeutic Chemical (ATC) Classes for XEGLYZE

P03AX	Other ectoparasiticides, incl. scabicides
P03A	ECTOPARASITICIDES, INCL. SCABICIDES
P03	ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for XEGLYZE

XEGLYZE is protected by five US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XEGLYZE

FDA Regulatory Exclusivity protecting XEGLYZE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No			Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No			Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No			Y	Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No			Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No			Y

International Patents for XEGLYZE

When does loss-of-exclusivity occur for XEGLYZE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Eurasian Patent Organization

European Patent Office

Japan

New Zealand

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XEGLYZE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4829785
Japan	6711751
South Africa	200706806	Methods and compositions for controlling ectoparasites
Hong Kong	1169045	用於控制體外寄生蟲的方法和組合物 (METHOD AND COMPOSITIONS FOR CONTROLLING ECTOPARASITES)
Japan	2007505032
Brazil	PI0606577	métodos de tratamento ou prevenção de infestação de ectoparasitas em hospedeiro de planta e de inibição da eclosão de ovo de ectoparasita