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Colorcon
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US Army
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McKinsey
Johnson and Johnson
QuintilesIMS

Generated: July 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022436

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NDA 022436 describes XERESE, which is a drug marketed by Valeant Bermuda and is included in one NDA. It is available from one supplier. There are two patents 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:Valeant Bermuda
Ingredient:acyclovir; hydrocortisone
Patents:2
Formulation / Manufacturing:see details
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 Valeant Pharmaceuticals North America LLC 0187-5104 N 0187-5104-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%;1%
Approval Date:Jul 31, 2009TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 24, 2018Product 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 a Free TrialPatent Expiration:Jul 24, 2018Product 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)
Patent:➤ Try a Free TrialPatent 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)

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Chubb
Queensland Health
Federal Trade Commission
Colorcon
QuintilesIMS
Express Scripts
Cipla
Mallinckrodt

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