XERESE Drug Patent Profile

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

Xerese is a drug marketed by Bausch and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-five patent family members in twenty-one 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.

DrugPatentWatch^® Generic Entry Outlook for Xerese

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 13, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XERESE

International Patents:	25
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XERESE
What excipients (inactive ingredients) are in XERESE?	XERESE excipients list
DailyMed Link:	XERESE at DailyMed

Drug patent expirations by year for XERESE

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for XERESE

Generic Entry Date for XERESE^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing 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.

Recent Clinical Trials for XERESE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Meda Pharmaceuticals	Phase 3
TKL Research, Inc.	Phase 3

See all XERESE clinical trials

Pharmacology for XERESE

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

Anatomical Therapeutic Chemical (ATC) Classes for XERESE

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XA	Corticosteroids, weak, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for XERESE

XERESE is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XERESE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.
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 XERESE

Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)

Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND CHILDREN (6 YEARS OF AGE AND OLDER)

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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
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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 XERESE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009	See Plans and Pricing	See Plans and Pricing
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for XERESE

See the table below for patents covering XERESE around the world.

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Country	Patent Number	Title	Estimated Expiration
Algeria	1966	Combinaison pharmaceutique nouvelle.	See Plans and Pricing
Turkey	9801439		See Plans and Pricing
Japan	4260220		See Plans and Pricing
Morocco	23800		See Plans and Pricing
China	1131034		See Plans and Pricing
Yugoslavia	7296		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for XERESE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	SPC/GB10/012	United Kingdom	See Plans and Pricing	PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498	10C0038	France	See Plans and Pricing	PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498	CA 2010 00009	Denmark	See Plans and Pricing
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description