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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Denavir (2023)

Total Spending

$889K

Total Claims

945

Beneficiaries

521

Avg Cost/Unit

$164.21

Spending Trend

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

YoY Change:+0.4%

5yr CAGR:+0.2%

Source: CMS Medicare Part D Spending by Drug (2023). 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.