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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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Paddock Laboratories, Inc., (Winston & Strawn LLP) - Citizen Petition FDA-2011-P-0486 · 4 docket documents Paddock Laboratories, Inc. filed a citizen petition on June 10, 2011, seeking paragraph IV patent certifications for numerous generic drug products including abacavir sulfate, various combination antiretroviral therapies, acyclovir sodium, albuterol sulfate formulations, alendronate sodium, and many	Other	2011-07-19	Granted	—
Matrix Laboratories, Inc. - Citizen Petition FDA-2007-P-0006 · 5 docket documents Matrix Laboratories Limited, India, filed this suitability petition requesting FDA approval to submit an Abbreviated New Drug Application for abacavir sulfate tablets 60 mg, a lower strength formulation of the reference listed drug ZIAGENO tablets 300 mg (NDA #20977), intended for pediatric and adol	Other	2008-06-19	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

140 trials from ClinicalTrials.gov, 123 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy NCT00102206	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	6	— → 2007-05
A Study of the Safety and Effectiveness of Different Doses of 1592U89 in HIV-Infected Patients NCT00002390	Phase 2	Completed	Glaxo Wellcome	—	—
Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure NCT00038506	Phase 4	Completed	ViiV Healthcare	100	2002-03 → 2004-08
Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection NCT00440947	Phase 3	Completed	ViiV Healthcare	515	2007-03 → 2010-07
Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects NCT00960622	Phase 4	Completed	St. Luke's-Roosevelt Hospital Center	17	2006-08 → 2009-07
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex NCT00002163	Phase 3	Completed	Glaxo Wellcome	—	—
A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection NCT00002183	Phase 1	Completed	Glaxo Wellcome	60	—
New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects NCT00044577	Phase 3	Completed	ViiV Healthcare	166	2002-07-16 → 2004-05-25
A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment NCT00006152	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	42	— → 2002-08
Pharmacokinetic Study Of EPZICOM Tablet NCT00337922	Phase 4	Completed	GlaxoSmithKline	8	2006-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Ziagen (2024)

Total Spending

$12K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$1.99

Spending Trend

$275K(2019)→$199K(2020)→$180K(2021)→$169K(2022)→$112K(2023)→$12K(2024)

YoY Change:-76.8%

5yr CAGR:-27.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 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

APOTEX INCABACAVIR SULFATE USP

DMF 236442010

DR REDDYS LABORATORIES LTDABACAVIR

DMF 244212010

CIPLA LTDABACAVIR SULFATE USP

DMF 262992012

LAURUS LABS LTDABACAVIR SULFATE, USP

DMF 288182014

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.