Viewing data from:

EDURANT

NDA

RILPIVIRINE HYDROCHLORIDE | N202022 | JANSSEN PRODUCTS LP

1 strength0 unique patents2 unique exclusivities

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayPED (+6 mo)Exclusivity

2027

Today

NPP

Sep. 15, 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

38 trials from ClinicalTrials.gov, 4 active, 25 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults NCT02951052	Phase 3	Active	ViiV Healthcare	618	2016-10-28 → 2029-12-31
Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults NCT03299049	Phase 3	Active	ViiV Healthcare	1,049	2017-10-27 → 2029-12-31
Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants NCT02938520	Phase 3	Active	ViiV Healthcare	631	2016-10-27 → 2029-12-31
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE NCT03635788	Phase 3	Active	National Institute of Allergy and Infectious Diseases (NIAID)	456	2019-03-28 → 2026-08-30
Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression NCT03251690	N/A	Completed	Mahidol University	246	2016-10-27 → 2018-04-30
A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine NCT01701882	Phase 3	Completed	St Stephens Aids Trust	40	2012-09 → 2013-11
FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir NCT01777997	Phase 4	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	38	2013-04-25 → 2017-02-07
SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms NCT02529059	Phase 4	Completed	St Stephens Aids Trust	40	2015-11 → 2017-05
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine NCT01641809	Phase 2	Completed	ViiV Healthcare	244	2012-08-06 → 2019-01-15
A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment NCT01709084	Phase 3	Completed	Janssen-Cilag International NV	426	2013-10-02 → 2020-07-02

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

$48.12

per ea

Lowest NADAC/Unit

$48.12

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59676027801EDURANT 25 MG TABLET	$48.12	EA	Brand	—	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1086.89

Highest Price

$1483.34

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59676-0278-01EDURANT 25MG TAB	$1483.34	FSS	Janssen Products, LP	09/28/2030
59676-0278-01EDURANT 25MG TAB	$1086.89	Big4	Janssen Products, LP	09/28/2030

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

Medicare Part D Spending

CMS annual spending data for Edurant (2024)

Total Spending

$23.9M

Total Claims

15,435

Beneficiaries

1,891

Avg Cost/Unit

$48.47

Spending Trend

$31.6M(2019)→$29.8M(2020)→$28.0M(2021)→$27.1M(2022)→$25.8M(2023)→$23.9M(2024)

YoY Change:+1.8%

5yr CAGR:+5.0%

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

API Supply Chain10 active DMFs1 inactive

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

JANSSEN PHARMACEUTICA NVRILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE

DMF 238242010

MATRIX PHARMACORP PRIVATE LTDRILPIVIRINE HYDROCHLORIDE

DMF 272532013

HETERO DRUGS LTDRILPIVIRINE HYDROCHLORIDE

DMF 293012015

LAURUS LABS LTDRILPIVIRINE HYDROCHLORIDE

DMF 298412015

MSN PHARMACHEM PRIVATE LTDRILPIVIRINE HYDROCHLORIDE [ROUTE CODE RC]

DMF 304232016

CIPLA LTDRILPIVIRINE HYDROCHLORIDE

DMF 307732017

REYOUNG CORPORATIONRILPIVIRINE HYDROCHLORIDE

DMF 374792022

CIPLA LTDRILPIVIRINE

DMF 379402023

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDRILPIVIRINE HYDROCHLORIDE

DMF 395522024

MSN PHARMACHEM PRIVATE LTDRILPIVIRINE

DMF 397292024

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDInactiveRILPIVIRINE HYDROCHLORIDE

DMF 263052012

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Mar 18, 2024	SUPPL -22	View Letter (PDF)
Mar 18, 2024	SUPPL -20	View Letter (PDF)
Oct 20, 2022	SUPPL -19	View Letter (PDF)
Mar 30, 2022	SUPPL -18	View Letter (PDF)
Mar 30, 2022	SUPPL -17	View Letter (PDF)
Feb 1, 2022	SUPPL -16	View Letter (PDF)
Jan 22, 2021	SUPPL -14	View Letter (PDF)
May 15, 2019	SUPPL -13	View Letter (PDF)
Feb 2, 2018	SUPPL -11	View Letter (PDF)
Sep 19, 2017	SUPPL -10	View Letter (PDF)
Aug 28, 2015	SUPPL -8	View Letter (PDF)
May 11, 2015	SUPPL -9	View Letter (PDF)
May 6, 2014	SUPPL -7	View Letter (PDF)
Jun 21, 2013	SUPPL -5	View Letter (PDF)
Dec 11, 2012	SUPPL -2	View Letter (PDF)
Aug 15, 2012	SUPPL -3	View Letter (PDF)
May 24, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 25MG BASE

RLDAB

0 patents2 exclusivities▴

TABLET;ORAL | Approved: May 20, 2011

Exclusivities (2)

Code	Date	Status
NPP	Mar 15, 2027	< 1 year
PED	Sep 15, 2027	Active