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TRIZIVIR

NDA

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE | N021205 | VIIV HEALTHCARE CO

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Trizivir (2023)

Total Spending

$1.1M

Total Claims

618

Beneficiaries

Avg Cost/Unit

$28.19

Spending Trend

$342K(2019)→$789K(2020)→$1.3M(2021)→$1.2M(2022)→$1.1M(2023)

YoY Change:+0.9%

5yr CAGR:+0.5%

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

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Feb 18, 2021	SUPPL -41	View Letter (PDF)
May 14, 2019	SUPPL -38	View Letter (PDF)
May 3, 2018	SUPPL -37	View Letter (PDF)
Mar 20, 2017	SUPPL -36	View Letter (PDF)
Mar 3, 2017	SUPPL -35	View Letter (PDF)
Oct 2, 2015	SUPPL -34	View Letter (PDF)
May 22, 2012	SUPPL -31	View Letter (PDF)
Mar 13, 2012	SUPPL -30	View Letter (PDF)
Nov 22, 2011	SUPPL -29	View Letter (PDF)
May 17, 2011	SUPPL -28	View Letter (PDF)
Apr 4, 2011	SUPPL -23	View Letter (PDF)
Aug 10, 2010	SUPPL -24	View Letter (PDF)
Mar 11, 2009	SUPPL -21	View Letter (PDF)
May 9, 2007	SUPPL -18	View Letter (PDF)
Aug 18, 2006	SUPPL -14	View Letter (PDF)
May 17, 2005	SUPPL -11	View Letter (PDF)
Jun 28, 2004	ORIG -1	View Letter (PDF)
Mar 1, 2004	SUPPL -4	View Letter (PDF)
Mar 1, 2004	SUPPL -3	View Letter (PDF)
Oct 8, 2002	SUPPL -7	View Letter (PDF)
Aug 13, 2002	SUPPL -6	View Letter (PDF)
Feb 5, 2002	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 14, 2000

No patent or exclusivity listings for this strength.