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Serving leading biopharmaceutical companies globally:

Accenture
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Generated: January 23, 2018

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 Pharms Inc and is included in one NDA. It is available from four 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 two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the penciclovir profile page.
Summary for 020629
Tradename:DENAVIR
Applicant:Mylan Pharms Inc
Ingredient:penciclovir
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 020629
Ingredient-typeNucleoside Analog
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 Prestium Pharma, Inc. 40076-624 40076-624-05 1 TUBE in 1 CARTON (40076-624-05) > 5 g in 1 TUBE
DENAVIR penciclovir CREAM;TOPICAL 020629 NDA Prestium Pharma, Inc. 40076-624 40076-624-01 .5 g in 1 POUCH (40076-624-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 24, 1996TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Oct 22, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
Patent:➤ SubscribePatent 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 Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
UBS
Farmers Insurance
Teva
Julphar
Federal Trade Commission
Johnson and Johnson
Boehringer Ingelheim
Cantor Fitzgerald

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 verifification 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.

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