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Express Scripts
Harvard Business School

Last Updated: August 11, 2020

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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 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.

US ANDA Litigation and 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
Drug patent expirations by year for XERESE
Drug Prices for XERESE

See drug prices for XERESE

Generic Entry Opportunity Date for XERESE
Generic Entry Date for XERESE*:
Constraining patent/regulatory exclusivity:

*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

TKL Research, Inc.Phase 3
Meda PharmaceuticalsPhase 3

See all XERESE clinical trials

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

Supplementary Protection Certificates for XERESE

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

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.