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INTELENCE

NDA

ETRAVIRINE | N022187 | JANSSEN RESEARCH AND DEVELOPMENT LLC

3 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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

40 trials from ClinicalTrials.gov, 34 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants NCT04208373	Phase 1	Completed	Janssen Research & Development, LLC	32	2019-12-20 → 2020-03-10
A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure NCT01641367	Phase 4	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	545	2013-02-22 → 2018-12-31
4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV Patients NCT02157311	Phase 3	Completed	ANRS, Emerging Infectious Diseases	100	2014-07 → 2016-01
GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir NCT00867152	Phase 1	Completed	ViiV Healthcare	17	2009-04 → 2009-05
Pilot Study Switching Individuals Receiving EFV With Continuing Central Nervous System Toxicity to TMC125 NCT00792324	Phase 3	Completed	St Stephens Aids Trust	24	2008-06 → 2009-08
A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients NCT00903682	Phase 2	Completed	Janssen-Cilag International NV	157	2009-06 → 2011-01
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants NCT00980538	Phase 3	Completed	Janssen Sciences Ireland UC	180	2009-12-09 → 2026-04-08
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
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
Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers NCT01427504	N/A	Completed	University of Colorado, Denver	26	2011-08 → 2012-03

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs (1 brand, 2 generic)

Highest NADAC/Unit

$24.30

per ea

Lowest NADAC/Unit

$7.77

per ea

Brand NDCs

Generic NDCs

Avg Brand: $24.30

Avg Generic: $9.59

61% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59676057101INTELENCE 200 MG TABLET	$24.30	EA	Brand	$11.41	2026-06-17
10147057101ETRAVIRINE 200 MG TABLET	$11.41	EA	Generic	—	2026-06-17
10147057001ETRAVIRINE 100 MG TABLET	$7.77	EA	Generic	—	2026-03-18

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 (5 FSS, 3 Big4)

Lowest Price

$280.30

Highest Price

$1497.88

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59676-0571-01INTELENCE 200MG TAB	$1497.88	FSS	Janssen Products, LP	09/28/2030
59676-0571-01INTELENCE 200MG TAB	$1060.92	Big4	Janssen Products, LP	09/28/2030
59676-0572-01INTELENCE 25MG TAB	$374.46	FSS	Janssen Products, LP	09/28/2030
59676-0572-01INTELENCE 25MG TAB	$280.30	Big4	Janssen Products, LP	09/28/2030
59676-0570-01INTELENCE 100MG TAB	$1497.88	FSS	Janssen Products, LP	09/28/2030
59676-0570-01INTELENCE 100MG TAB	$1121.24	Big4	Janssen Products, LP	09/28/2030
10147-0570-01ETRAVIRINE 100MG TAB	$654.58	FSS	Johnson & Johnson Health Care Systems, Inc. obo Patriot Pharm	12/31/2027
10147-0571-01ETRAVIRINE 200MG TAB	$547.08	FSS	Johnson & Johnson Health Care Systems, Inc. obo Patriot Pharm	12/31/2027

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

Medicare Part D Spending

CMS annual spending data for Intelence (2024)

Total Spending

$2.5M

Total Claims

1,596

Beneficiaries

281

Avg Cost/Unit

$22.63

Spending Trend

$80.1M(2019)→$68.2M(2020)→$46.9M(2021)→$12.9M(2022)→$4.7M(2023)→$2.5M(2024)

YoY Change:-2.9%

5yr CAGR:+0.1%

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

API Supply Chain5 active DMFs1 inactive

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

JANSSEN PHARMACEUTICA NVETRAVIRINE (R165335) DRUG SUBSTANCE

DMF 204402007

HETERO LABS LTDETRAVIRINE

DMF 255502011

MATRIX PHARMACORP PRIVATE LTDETRAVIRINE

DMF 288132014

MSN LIFE SCIENCES PRIVATE LTDETRAVIRINE [ROUTE CODE "EV"]

DMF 294042015

HETERO LABS LTDETRAVIRINE PREMIX

DMF 358352021

APOTEX PHARMACHEM INDIA PVT LTDInactiveETRAVIRINE

DMF 279232014

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2019	SUPPL -25	View Letter (PDF)
Nov 15, 2018	SUPPL -23	View Letter (PDF)
Jul 23, 2018	SUPPL -24	View Letter (PDF)
Aug 21, 2014	SUPPL -16	View Letter (PDF)
Mar 1, 2013	SUPPL -12	View Letter (PDF)
Mar 1, 2013	SUPPL -11	View Letter (PDF)
Mar 1, 2013	SUPPL -14	View Letter (PDF)
Aug 15, 2012	SUPPL -10	View Letter (PDF)
Mar 28, 2012	SUPPL -9	View Letter (PDF)
Oct 12, 2011	SUPPL -8	View Letter (PDF)
Dec 28, 2010	SUPPL -7	View Letter (PDF)
Dec 22, 2010	SUPPL -6	View Letter (PDF)
Mar 3, 2010	SUPPL -3	View Letter (PDF)
Nov 10, 2009	SUPPL -2	View Letter (PDF)
Jan 23, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 18, 2008

No patent or exclusivity listings for this strength.

#002 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 22, 2010

#003 — 25MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 26, 2012