Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: October 22, 2019

DrugPatentWatch Database Preview

DENAVIR Drug Profile

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When do Denavir patents expire, and what generic alternatives are available?

Denavir is a drug marketed by Mylan and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and five patent family members in thirty-four countries.

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.

Drug patent expirations by year for DENAVIR
Drug Prices for DENAVIR

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Generic Entry Opportunity Date for DENAVIR
Generic Entry Date for DENAVIR*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for DENAVIR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Squarex, LLCPhase 2

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Recent Litigation for DENAVIR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Ranbaxy Laboratories Limited2007-03-09
NOVARTIS PHARMACEUTICALS CORPORATION v. ROXANE LABORATORIES, INC.
NOVARTIS PHARMACEUITCALS CORPORATION v. ROXANE LABORATORIES, INC.

See all DENAVIR litigation

Pharmacology for DENAVIR

US Patents and Regulatory Information for DENAVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DENAVIR

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DENAVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0141927 97C0033 Belgium   Start Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228
0182024 SPC/GB94/002 United Kingdom   Start Trial SPC/GB94/002: 20050910, EXPIRES: 20081209
0141927 SPC/GB96/014 United Kingdom   Start Trial SPC/GB96/014: 20040810, EXPIRES: 20090809
0296560 98C0015 Belgium   Start Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Boehringer Ingelheim
Merck
McKinsey
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 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.