PENCICLOVIR - Generic Drug Details

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What are the generic drug sources for penciclovir and what is the scope of patent protection?

Penciclovir is the generic ingredient in two branded drugs marketed by Mylan, Padagis Israel, Teva Pharms Usa, and Torrent, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for penciclovir. Four suppliers are listed for this compound.

Summary for PENCICLOVIR

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	3
Patent Applications:	5,945
Drug Prices:	Drug price trends for PENCICLOVIR
What excipients (inactive ingredients) are in PENCICLOVIR?	PENCICLOVIR excipients list
DailyMed Link:	PENCICLOVIR at DailyMed

See drug prices for PENCICLOVIR

Recent Clinical Trials for PENCICLOVIR

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

Sponsor	Phase
Squarex, LLC	Phase 2
EMS	Phase 3
Novartis	Phase 4

See all PENCICLOVIR clinical trials

Pharmacology for PENCICLOVIR

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

Anatomical Therapeutic Chemical (ATC) Classes for PENCICLOVIR

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 PENCICLOVIR

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	PENCICLOVIR	penciclovir	CREAM;TOPICAL	216981-001	Aug 7, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	PENCICLOVIR	penciclovir	CREAM;TOPICAL	212368-001	Sep 27, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	PENCICLOVIR	penciclovir	CREAM;TOPICAL	212710-001	Nov 9, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 PENCICLOVIR

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

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