➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Merck
Boehringer Ingelheim
Colorcon
Moodys
Mallinckrodt

Last Updated: August 3, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022436


Email this page to a colleague

« Back to Dashboard

NDA 022436 describes XERESE, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the XERESE profile page.

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 022436
Tradename:XERESE
Applicant:Bausch
Ingredient:acyclovir; hydrocortisone
Patents:1
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 022436
Generic Entry Date for 022436*:
Constraining patent/regulatory exclusivity:
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 NDA: 022436
Suppliers and Packaging for NDA: 022436
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XERESE acyclovir; hydrocortisone CREAM;TOPICAL 022436 NDA Bausch Health US LLC 0187-5104 0187-5104-01 1 TUBE in 1 CARTON (0187-5104-01) > 5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%;1%
Approval Date:Jul 31, 2009TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Nov 13, 2022Product Flag?YSubstance Flag?Delist Request?
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)
Patent:⤷  Try it FreePatent Expiration:Nov 13, 2022Product Flag?YSubstance Flag?Delist Request?
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)

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Colorcon
AstraZeneca
Johnson and Johnson
Baxter

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.