Viewing data from:

VIREAD

NDA

TENOFOVIR DISOPROXIL FUMARATE | N021356 | GILEAD SCIENCES INC

4 strengths0 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc., v. Teva Pharmaceuticals USA, Inc. et al 1:2010cv01796 4 patentsANDA 91-612, 90-894, 91-215tenofovir disoproxil fumarate	S.D.N.Y.	2010-03-05	Terminated 2013-02-20	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

206 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 156 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection NCT03343431	Phase 3	Active	Institut de Recherche pour le Developpement	504	2018-08-02 → 2025-06-30
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women NCT03164564	Phase 3	Active	National Institute of Allergy and Infectious Diseases (NIAID)	3,224	2017-11-07 → 2026-10-17
ANCHORS Alcohol & Sexual Health Study: UH3 Project NCT04331704	Phase 4	Recruiting	University of Florida	88	2021-01-12 → 2026-06-30
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF NCT03920618	N/A	Recruiting	Third Affiliated Hospital, Sun Yat-Sen University	150	2019-02-21 → 2024-12-31
Efficacy and Safety of a Dolutegravir-based Regimen for the Initial Management of HIV Infected Adults in Resource-limited Settings NCT02777229	Phase 3	Completed	ANRS, Emerging Infectious Diseases	616	2016-07 → 2021-07
Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus NCT02995005	Phase 1/2	Completed	Johns Hopkins Bloomberg School of Public Health	98	2018-05-24 → 2023-01-31
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women NCT03060785	Phase 1	Completed	Johns Hopkins University	16	2016-03-08 → 2018-05-31
A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women NCT03270969	Phase 1	Completed	University of Nebraska	15	2018-01-05 → 2018-09-10
Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients NCT03360682	Phase 4	Completed	Fundacion Clinic per a la Recerca Biomédica	19	2018-04-13 → 2020-05-21
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection NCT00105079	Phase 3	Completed	Hoffmann-La Roche	337	2005-04 → 2008-07

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$40.73

per ea

Lowest NADAC/Unit

$40.73

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61958040101VIREAD 300 MG TABLET	$40.73	EA	Brand	$0.3107	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$749.50

Highest Price

$753.33

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-0401-01VIREAD 300MG TAB	$753.33	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0401-01VIREAD 300MG TAB	$753.33	Big4	Gilead Sciences, Inc.	09/29/2026
61958-0404-01VIREAD 150MG TAB	$749.50	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0404-01VIREAD 150MG TAB	$749.50	Big4	Gilead Sciences, Inc.	09/29/2026
61958-0405-01VIREAD 200MG TAB	$749.50	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0405-01VIREAD 200MG TAB	$749.50	Big4	Gilead Sciences, Inc.	09/29/2026
61958-0406-01VIREAD 250MG TAB	$749.50	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0406-01VIREAD 250MG TAB	$749.50	Big4	Gilead Sciences, Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Viread (2024)

Total Spending

$2.9M

Total Claims

1,825

Beneficiaries

296

Avg Cost/Unit

$38.91

Spending Trend

$9.7M(2019)→$6.4M(2020)→$4.6M(2021)→$4.2M(2022)→$3.6M(2023)→$2.9M(2024)

YoY Change:-6.8%

5yr CAGR:-1.1%

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

API Supply Chain31 active DMFs8 inactive

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

CIPLA LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 200032006

MATRIX PHARMACORP PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 201082007

APITORIA PHARMA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE (NON-STERILE DRUG SUBSTANCE)

DMF 210962007

HETERO LABS LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 215402008

MACLEODS PHARMACEUTICALS LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 247642011

CIPLA LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS B)

DMF 248522011

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 253042011

LUPIN LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 257872012

SOLARA ACTIVE PHARMA SCIENCES LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 260832012

LAURUS LABS LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS-2)

DMF 270872013

CYDMAX INDIA PHARMA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)]

DMF 271432013

MATRIX PHARMACORP PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS-II)

DMF 274562013

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 284602014

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 285072014

JINGMEN SHUAIBANG CHEMICAL SCIENCE AND TECHNOLOGY CO LTDTENOFOVIR DISOPROXIL FUMARATE (DRUG SUBSTANCE)

DMF 288152014

SHANDONG ANHONG PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 303552016

AURISCO PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 307302016

HETERO LABS LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS II)

DMF 310102016

YANCHENG DESANO PHARMACEUTICAL CO LTDTENOFOVIR

DMF 311462016

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 314612017

LAURUS LABS LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS-3)

DMF 319582017

HUANGSHI FUERTAI PHARMACEUTICAL TECHNOLOGY CO LTDTENOFOVIR

DMF 334062018

JINGMEN SHUAIBANG CHEMICAL SCIENCE AND TECHNOLOGY CO LTDTENOFOVIR

DMF 335492019

CHROMO LABORATORIES INDIA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 353082021

INNOVARE LABS PRIVATE LTDTENOFOVIR (DRUG SUBSTANCE INTERMEDIATE)

DMF 354252020

JIANGSU PUXIN PHARMACEUTICALS CO LTDTENOFOVIR

DMF 354442021

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 356382023

STYRAX PHARMA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 359192021

EMCURE PHARMACEUTICALS LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 372732022

VIYASH LIFE SCIENCES PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 373052022

EMNAR PHARMA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 408432024

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveTENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE

DMF 210982007

EMCURE PHARMACEUTICALS LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 226232009

LAURUS LABS LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 234502010

SEQUENT SCIENTIFIC LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 234752010

UNIMARK REMEDIES LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 263192012

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDInactiveTENOFOVIR

DMF 267672012

JINGMEN SHUAIBANG CHEMICAL SCIENCE AND TECHNOLOGY CO LTDInactiveTENOFOVIR (DRUG SUBSTANCE INTERMEDIATE)

DMF 280692014

TYCHE INDUSTRIES LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 281462014

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

Approval Letters

32 letters from Drugs@FDA

Date	Submission	Document
Apr 24, 2019	SUPPL -58	View Letter (PDF)
Dec 20, 2018	SUPPL -57	View Letter (PDF)
Jul 30, 2018	SUPPL -56	View Letter (PDF)
Apr 12, 2017	SUPPL -55	View Letter (PDF)
Feb 18, 2016	SUPPL -52	View Letter (PDF)
Jun 2, 2015	SUPPL -49	View Letter (PDF)
Oct 25, 2013	SUPPL -48	View Letter (PDF)
Jul 26, 2013	SUPPL -46	View Letter (PDF)
Apr 3, 2013	SUPPL -47	View Letter (PDF)
Aug 20, 2012	SUPPL -42	View Letter (PDF)
Aug 9, 2012	SUPPL -40	View Letter (PDF)
Jan 20, 2012	SUPPL -38	View Letter (PDF)
Nov 22, 2011	SUPPL -41	View Letter (PDF)
Sep 21, 2011	SUPPL -37	View Letter (PDF)
Oct 19, 2010	SUPPL -35	View Letter (PDF)
Oct 13, 2010	SUPPL -34	View Letter (PDF)
Mar 29, 2010	SUPPL -33	View Letter (PDF)
Jan 25, 2010	SUPPL -28	View Letter (PDF)
Nov 10, 2009	SUPPL -27	View Letter (PDF)
Nov 6, 2008	SUPPL -26	View Letter (PDF)
Aug 13, 2008	SUPPL -25	View Letter (PDF)
May 21, 2008	SUPPL -24	View Letter (PDF)
May 29, 2007	SUPPL -21	View Letter (PDF)
Mar 23, 2006	SUPPL -16	View Letter (PDF)
Dec 5, 2005	SUPPL -17	View Letter (PDF)
May 17, 2005	SUPPL -11	View Letter (PDF)
Jul 6, 2004	SUPPL -10	View Letter (PDF)
Nov 25, 2003	SUPPL -6	View Letter (PDF)
Oct 16, 2003	SUPPL -5	View Letter (PDF)
Aug 28, 2003	SUPPL -3	View Letter (PDF)
Dec 2, 2002	SUPPL -1	View Letter (PDF)
Oct 26, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 300MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 26, 2001

No patent or exclusivity listings for this strength.

#002 — 150MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 18, 2012

#003 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 18, 2012

#004 — 250MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 18, 2012