Viewing data from:

DENAVIR

NDA

PENCICLOVIR | N020629 | MYLAN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis NCT01257074	Phase 3	Completed	EMS	76	2012-02 → 2012-10
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers NCT00820534	Phase 4	Completed	Novartis	126	2008-12 → 2009-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$155.24

per gm

Lowest NADAC/Unit

$52.03

per gm

Brand NDCs

Generic NDCs

Avg Brand: $155.24

Avg Generic: $52.03

66% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00378972055DENAVIR 1% CREAM	$155.24	GM	Brand	$52.03	2026-10-21
00378089655PENCICLOVIR 1% CREAM	$52.03	GM	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$184.33

Highest Price

$775.27

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00378-0896-55PENCICLOVIR 1% CREAM.TOP	$184.33	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-0896-55PENCICLOVIR 1% CREAM.TOP	$444.97	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-9720-55DENAVIR 1% CREAM.TOP	$598.86	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-9720-55DENAVIR 1% CREAM.TOP	$775.27	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Denavir (2024)

Total Spending

$466K

Total Claims

518

Beneficiaries

257

Avg Cost/Unit

$155.22

Spending Trend

$6.5M(2019)→$6.5M(2020)→$5.6M(2021)→$4.9M(2022)→$889K(2023)→$466K(2024)

YoY Change:-5.5%

5yr CAGR:-1.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs1 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

SMS PHARMACEUTICALS LTDPENCICLOVIR

DMF 297242015

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDPENCICLOVIR (API)

DMF 307582016

CHEMWERTH INCPENCICLOVIR

DMF 332602018

API PHARMA TECH LLCPENCICLOVIR

DMF 345142020

ALEMBIC PHARMACEUTICALS LTDPENCICLOVIR

DMF 350322020

MAITHRI DRUGS PRIVATE LTDPENCICLOVIR

DMF 352432020

TORRENT PHARMACEUTICALS LTDPENCICLOVIR

DMF 364102021

MYLAN LABORATORIES LTDInactivePENCICLOVIR

DMF 343752019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Dec 12, 2018	SUPPL -19	View Letter (PDF)
Sep 13, 2013	SUPPL -16	View Letter (PDF)
Oct 16, 2003	SUPPL -8	View Letter (PDF)
Apr 18, 2003	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLDAB

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Sep 24, 1996

No patent or exclusivity listings for this strength.