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XERESE Drug Profile

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

Xerese is a drug marketed by Valeant Bermuda and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-seven patent family members in twenty-nine countries.

The generic ingredient in XERESE is acyclovir; hydrocortisone. There are fifty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acyclovir; hydrocortisone profile page.

Summary for XERESE

International Patents:	57
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XERESE
DailyMed Link:	XERESE at DailyMed

Generic Entry Opportunity Date for XERESE

NDA:

022436

Dosage:

CREAM;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 XERESE

Ingredient-type	Nucleoside Analog
Drug Class	Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor Corticosteroid
Mechanism of Action	DNA Polymerase Inhibitors Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for XERESE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Bermuda	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009		RX	Yes	Yes			Y
Valeant Bermuda	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009		RX	Yes	Yes			Y

Expired US Patents for XERESE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Bermuda	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009
Valeant Bermuda	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009

International Patents for XERESE

Country	Document Number	Estimated Expiration
United Kingdom	9601544
Spain	2233104
Australia	772435