Viewing data from:

PREZISTA

NDA

DARUNAVIR | N202895 | JANSSEN PRODUCTS LP

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)TodayPED (+6 mo)

2027

Today

7700645

Jun. 26, 2027

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

143 trials from ClinicalTrials.gov, 114 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers NCT00936793	Phase 1	Completed	National Institutes of Health Clinical Center (CC)	53	2009-07-06 → 2011-06-10
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults NCT00830804	Phase 2	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	113	2009-04 → 2010-09
VX-950-TiDP24-C124: A Phase I Trial to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state.NCT00775125	Phase 1	Completed	Tibotec BVBA	40	2008-06 → 2008-10
A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients NCT01199939	Phase 2	Completed	Tibotec, Inc	54	2010-05 → 2012-10
GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.NCT00381303	Phase 3	Completed	Tibotec, Inc	429	2006-11 → 2008-12
Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses NCT00460382	Phase 2	Completed	French National Agency for Research on AIDS and Viral Hepatitis	103	2007-05 → 2009-09
Double Protease Inhibitor to Darunavir Switch Study NCT00531557	Phase 4	Completed	St Stephens Aids Trust	12	2007-09 → 2008-11
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue NCT00855088	Phase 1	Completed	University of North Carolina, Chapel Hill	13	2009-07 → 2011-02
Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens NCT00994344	Phase 4	Completed	Germans Trias i Pujol Hospital	73	2009-10 → 2012-10
TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV NCT01281813	Phase 3	Completed	Janssen Sciences Ireland UC	145	2011-08-08 → 2021-07-29

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$883.76

Highest Price

$1198.88

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59676-0565-01PREZISTA ORAL SUSPENSION 100MG/ML	$1198.88	FSS	Janssen Products, LP	09/28/2030
59676-0565-01PREZISTA ORAL SUSPENSION 100MG/ML	$883.76	Big4	Janssen Products, LP	09/28/2030

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

API Supply Chain25 active DMFs8 inactive

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

JANSSEN PHARMACEUTICA NVDARUNAVIR (R319064) DRUG SUBSTANCE

DMF 188252005

CIPLA LTDDARUNAVIR

DMF 236602011

CIPLA LTDDARUNAVIR HYDRATE

DMF 236612010

CIPLA LTDDARUNAVIR ETHANOLATE

DMF 236622010

HETERO LABS LTDDARUNAVIR AMORPHOUS

DMF 238542010

MATRIX PHARMACORP PRIVATE LTDDARUNAVIR

DMF 238732010

HETERO LABS LTDDARUNAVIR ETHANOLATE

DMF 279972014

MICRO LABS LTDDARUNAVIR ETHANOLATE

DMF 291572015

MSN LIFE SCIENCES PRIVATE LTDDARUNAVIR ETHANOLATE

DMF 305892016

MATRIX PHARMACORP PRIVATE LTDDARUNAVIR (PROCESS-II)

DMF 305962016

MATRIX PHARMACORP PRIVATE LTDDARUNAVIR ETHANOLATE

DMF 307352016

RAKS PHARMA PVT LTDDARUNAVIR

DMF 308032016

MSN LIFE SCIENCES PRIVATE LTDDARUNAVIR (AMORPHOUS)

DMF 308822016

HETERO LABS LTDDARUNAVIR ETHANOLATE (PROCESS-II)

DMF 310112016

LAURUS LABS LTDDARUNAVIR

DMF 311982017

APITORIA PHARMA PRIVATE LTDDARUNAVIR PROPYLENE GLYCOLATE

DMF 313582017

LUPIN MANUFACTURING SOLUTIONS LTDDARUNAVIR ETHANOLATE (PROCESS-B)

DMF 314982017

PORTON PHARMA SOLUTIONS LTDDARUNAVIR ETHANOLATE

DMF 337982019

ZYDUS LIFESCIENCES LTDDARUNAVIR

DMF 338952019

INNOVARE LABS PRIVATE LTDDARUNAVIR

DMF 355082021

HETERO LABS LTDDARUNAVIR AMORPHOUS (PROCESS-II)

DMF 358342021

CHROMO LABORATORIES INDIA PRIVATE LTDDARUNAVIR ETHANOLATE

DMF 369762024

ARENE LIFE SCIENCES PRIVATE LTDDARUNAVIR ETHANOLATE

DMF 379162023

LAURUS LABS LTDDARUNAVIR ETHANOLATE

DMF 389802024

CIPLA LTDDARUNAVIR HYDRATE (PROCESS II)

DMF 408262025

LUPIN LTDInactiveDARUNAVIR ETHANOLATE

DMF 238502011

MSN PHARMACHEM PRIVATE LTDInactiveDARUNAVIR [ROUTE CODE - "DI"]

DMF 270382013

MSN PHARMACHEM PRIVATE LTDInactiveDARUNAVIR ETHANOLATE [ROUTE CODE - DN]

DMF 274212013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveDARUNAVIR

DMF 274362013

LUPIN LTDInactiveDARUNAVIR N-PROPANOLATE

DMF 291182015

LUPIN LTDInactiveDARUNAVIR (AMORPHOUS)

DMF 294552015

CIPLA LTDInactiveDARUNAVIR HYDRATE (PROCESS II)

DMF 302862016

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveDARUNAVIR

DMF 314942017

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

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Apr 3, 2023	SUPPL -36	View Letter (PDF)
Oct 21, 2022	SUPPL -35	View Letter (PDF)
Apr 15, 2022	SUPPL -34	View Letter (PDF)
Aug 18, 2021	SUPPL -32	View Letter (PDF)
Jul 27, 2021	SUPPL -31	View Letter (PDF)
Dec 23, 2020	SUPPL -29	View Letter (PDF)
Jun 4, 2019	SUPPL -27	View Letter (PDF)
Mar 25, 2019	SUPPL -24	View Letter (PDF)
Feb 13, 2019	SUPPL -25	View Letter (PDF)
Sep 12, 2018	SUPPL -22	View Letter (PDF)
Jan 30, 2018	SUPPL -21	View Letter (PDF)
Jun 22, 2017	SUPPL -20	View Letter (PDF)
Sep 20, 2016	SUPPL -19	View Letter (PDF)
Jun 21, 2016	SUPPL -17	View Letter (PDF)
May 28, 2015	SUPPL -13	View Letter (PDF)
Apr 1, 2015	SUPPL -16	View Letter (PDF)
Apr 8, 2014	SUPPL -11	View Letter (PDF)
Nov 8, 2013	SUPPL -10	View Letter (PDF)
Apr 25, 2013	SUPPL -4	View Letter (PDF)
Feb 26, 2013	SUPPL -7	View Letter (PDF)
Feb 4, 2013	SUPPL -6	View Letter (PDF)
Feb 4, 2013	SUPPL -5	View Letter (PDF)
Nov 14, 2012	SUPPL -3	View Letter (PDF)
Jun 7, 2012	SUPPL -2	View Letter (PDF)
Feb 29, 2012	SUPPL -1	View Letter (PDF)
Dec 27, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/ML

RLD

1 patent0 exclusivities▴

SUSPENSION;ORAL | Approved: Dec 16, 2011

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7700645	Dec 26, 2026PED: Jun 26, 2027	PED	Yes	Yes	—	—