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ZIAGEN

NDA

ABACAVIR SULFATE | N020977 | 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 Ziagen (2023)

Total Spending

$112K

Total Claims

176

Beneficiaries

Avg Cost/Unit

$8.55

Spending Trend

$275K(2019)→$199K(2020)→$180K(2021)→$169K(2022)→$112K(2023)

YoY Change:+1.7%

5yr CAGR:+3.3%

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

API Supply Chain12 active DMFs1 inactive

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

MATRIX PHARMACORP PRIVATE LTDABACAVIR SULFATE USP

DMF 182292005

APITORIA PHARMA PRIVATE LTDABACAVIR SULFATE USP

DMF 182562005

OLON SPAABACAVIR SULFATE

DMF 205152007

HETERO LABS LTDABACAVIR SULFATE

DMF 221962008

LUPIN LTDABACAVIR SULFATE USP

DMF 236182010

SIGNA SA DE CVABACAVIR SULFATE USP

DMF 236442010

DR REDDYS LABORATORIES LTDABACAVIR

DMF 244212010

CIPLA LTDABACAVIR SULFATE USP

DMF 262992012

HETERO LABS LTDABACAVIR SULFATE (PROCESS-II), USP

DMF 295872015

LAURUS LABS LTDABACAVIR SULFATE USP (PROCESS-2)

DMF 330312018

CHROMO LABORATORIES INDIA PRIVATE LTDABACAVIR SULFATE USP

DMF 369672024

APITORIA PHARMA PRIVATE LTDABACAVIR SULFATE USP (PROCESS II)

DMF 395372024

LUPIN LTDInactiveABACAVIR SULFATE USP (PROCESS-2)

DMF 348912020

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

Approval Letters

27 letters from Drugs@FDA

Date	Submission	Document
Nov 27, 2020	SUPPL -35	View Letter (PDF)
May 10, 2018	SUPPL -33	View Letter (PDF)
May 10, 2018	SUPPL -34	View Letter (PDF)
Mar 24, 2017	SUPPL -32	View Letter (PDF)
Oct 2, 2015	SUPPL -30	View Letter (PDF)
Mar 25, 2015	SUPPL -27	View Letter (PDF)
Feb 24, 2015	SUPPL -28	View Letter (PDF)
Sep 13, 2013	SUPPL -26	View Letter (PDF)
May 22, 2012	SUPPL -25	View Letter (PDF)
Mar 19, 2012	SUPPL -24	View Letter (PDF)
Nov 22, 2011	SUPPL -23	View Letter (PDF)
May 17, 2011	SUPPL -22	View Letter (PDF)
Aug 10, 2010	SUPPL -20	View Letter (PDF)
Aug 25, 2009	SUPPL -12	View Letter (PDF)
Aug 25, 2009	SUPPL -11	View Letter (PDF)
Dec 29, 2008	SUPPL -19	View Letter (PDF)
Jul 23, 2008	SUPPL -17	View Letter (PDF)
May 9, 2007	SUPPL -16	View Letter (PDF)
Aug 21, 2006	SUPPL -14	View Letter (PDF)
Aug 5, 2004	SUPPL -12	View Letter (PDF)
Jul 28, 2004	SUPPL -13	View Letter (PDF)
Apr 20, 2004	SUPPL -11	View Letter (PDF)
Jul 28, 2003	SUPPL -10	View Letter (PDF)
Oct 2, 2002	SUPPL -7	View Letter (PDF)
Aug 14, 2002	SUPPL -8	View Letter (PDF)
Jan 28, 2002	SUPPL -5	View Letter (PDF)
Dec 17, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

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

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 17, 1998

No patent or exclusivity listings for this strength.