Viewing data from:

SYMFI

NDA

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | N022142 | 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 Symfi (2023)

Total Spending

$1.2M

Total Claims

377

Beneficiaries

110

Avg Cost/Unit

$45.96

Spending Trend

$4.0M(2019)→$3.9M(2020)→$2.2M(2021)→$1.6M(2022)→$1.2M(2023)

YoY Change:+19.8%

5yr CAGR:-4.6%

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 30, 2019	SUPPL -37	View Letter (PDF)
Mar 26, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG;300MG;300MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 22, 2018

No patent or exclusivity listings for this strength.