DENAVIR Drug Patent Profile

When do Denavir patents expire, and when can generic versions of Denavir launch?

Denavir is a drug marketed by Mylan and is included in one NDA.

The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the penciclovir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Denavir

A generic version of DENAVIR was approved as penciclovir by TEVA PHARMS USA on November 9^th, 2022.

Summary for DENAVIR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	1
Patent Applications:	4,669
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DENAVIR
What excipients (inactive ingredients) are in DENAVIR?	DENAVIR excipients list
DailyMed Link:	DENAVIR at DailyMed

See drug prices for DENAVIR

Recent Clinical Trials for DENAVIR

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

Sponsor	Phase
Squarex, LLC	Phase 2

See all DENAVIR clinical trials

Pharmacology for DENAVIR

Drug Class	Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DENAVIR

D06BB	Antivirals
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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	AB	RX	Yes	Yes

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
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996

International Patents for DENAVIR

See the table below for patents covering DENAVIR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2207503	EMPLOI D'AGENTS ANTIVIRAUX A BASE D'AMINOPURINE POUR LE TRAITEMENT ET LA PROPHYLAXIE D'INFECTIONS LATENTES PAR LES HERPESVIRUS (USE OF AMINOPURINE ANTIVIRAL AGENTS FOR THE TREATMENT AND PROPHYLAXIS OF LATENT HERPESVIRUS INFECTIONS)
Spain	8603887
Ireland	910249
Mexico	9704336	USO DE AGENTES ANTIVIRALES PARA EL TRATAMIENTO Y PROFILAXIS DE INFECCIONES LATENTES DE HERPESVIRUS. (USE OF AMINOPURINE ANTIVIRAL AGENTS FOR THE TREATMENT AND PROPHYLAXIS OF LATENT HERPESVIRUS INFECTIONS.)
Japan	H06293764	GUANINE DERIVATIVE AND PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITION CONTAINING IT
Australia	3197384

Supplementary Protection Certificates for DENAVIR

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