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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020629

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NDA 020629 describes DENAVIR, which is a drug marketed by Mylan and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the DENAVIR profile page.

The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the penciclovir profile page.
Summary for 020629
Tradename:DENAVIR
Applicant:Mylan
Ingredient:penciclovir
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 020629
Generic Entry Date for 020629*:
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: 020629
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 020629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DENAVIR penciclovir CREAM;TOPICAL 020629 NDA Mylan Pharmaceuticals Inc. 0378-9720 0378-9720-55 1 TUBE in 1 CARTON (0378-9720-55) > 5 g in 1 TUBE
DENAVIR penciclovir CREAM;TOPICAL 020629 NDA Prestium Pharma, Inc. 40076-624 40076-624-05 1 TUBE in 1 CARTON (40076-624-05) > 5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 24, 1996TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 22, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
Patent:  Start TrialPatent Expiration:Jun 17, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS

Expired US Patents for NDA 020629

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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