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

6 trials from ClinicalTrials.gov — 6 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
TAF in Early/Middle Pregnancy With CHB NCT07668934	Phase 4	By Invitation	The Third Affiliated Hospital of Guangzhou Medical University	816	2025-03-31 → 2028-03-30
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention NCT07473778	—	Recruiting	Gilead Sciences	3,000	2026-03-17 → 2029-04
Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study NCT05652478	Phase 2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	120	2026-07-07 → 2030-01-31
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)NCT07071623	Phase 3	Recruiting	Merck Sharp & Dohme LLC	4,580	2025-11-10 → 2027-10-18
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women NCT05403047	Phase 4	Recruiting	ANRS, Emerging Infectious Diseases	150	2023-08-22 → 2028-02
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)NCT07044297	Phase 3	Recruiting	Merck Sharp & Dohme LLC	4,390	2025-07-31 → 2027-07-22

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

Medicare Part D Spending

CMS annual spending data for Viread (2023)

Total Spending

$3.6M

Total Claims

2,191

Beneficiaries

348

Avg Cost/Unit

$41.76

Spending Trend

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

YoY Change:+0.9%

5yr CAGR:+2.3%

Source: CMS Medicare Part D Spending by Drug (2023). 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