Viewing data from:

CIMDUO

NDA

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | N022141 | MYLAN LABORATORIES LTD

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 Cimduo (2023)

Total Spending

$274K

Total Claims

169

Beneficiaries

Avg Cost/Unit

$39.26

Spending Trend

$195K(2019)→$338K(2020)→$287K(2021)→$242K(2022)→$274K(2023)

YoY Change:+9.3%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 23, 2018	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG;300MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 28, 2018

No patent or exclusivity listings for this strength.