Rilpivirine hydrochloride - Generic Drug Details

What are the generic drug sources for rilpivirine hydrochloride and what is the scope of freedom to operate?

Rilpivirine hydrochloride is the generic ingredient in two branded drugs marketed by Janssen Prods and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rilpivirine hydrochloride has two hundred and twenty-six patent family members in forty-six countries.

There are seven drug master file entries for rilpivirine hydrochloride. One supplier is listed for this compound.

Summary for rilpivirine hydrochloride

International Patents:	226
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	99
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rilpivirine hydrochloride
What excipients (inactive ingredients) are in rilpivirine hydrochloride?	rilpivirine hydrochloride excipients list
DailyMed Link:	rilpivirine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for rilpivirine hydrochloride

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

TABLET, FOR SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for rilpivirine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	PHASE2
Organization providing support methodology coordination (Institut Pierre Louis d'Epidmiologie et de Sant Publique)	PHASE2

See all rilpivirine hydrochloride clinical trials

Pharmacology for rilpivirine hydrochloride

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for rilpivirine hydrochloride

Anti-HIV Agents

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for rilpivirine hydrochloride

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for rilpivirine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes			Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes			Y	Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes

Expired US Patents for rilpivirine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011

International Patents for rilpivirine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Hungary	S1500051
Australia	2011201123	Combinations of a pyrimidine containing NNRTI with RT inhibitors
Eurasian Patent Organization	006656	ПРОИЗВОДНЫЕ ПИРИМИДИНА, ИНГИБИРУЮЩИЕ ВИЧ (HIV INHIBITING PYRIMIDINES DERIVATIVES)
Poland	1632232
Norway	2016025
Israel	160328	PYRIMIDINE DERIVATIVES, PROCESS AND INTERMEDIATES FOR PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM FOR INHIBITING HIV

Supplementary Protection Certificates for rilpivirine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	300850	Netherlands		PRODUCT NAME: COMBINATIE VAN: -RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	132016000024787	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, TENOFOVIR, IN PARTICOLARE TENOFOVIR DISOPROXIL FUMARATO E EMITRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1419152	CA 2012 00019	Denmark
1663240	PA2015037,C1663240-2	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, TENOFOVIRO, YPAC TENOFOVIRO DIZOPROKSILIO FUMARATO, IR EMTRICITABINODERINYS; REGISTRATION NO/DATE: EU/1/11/737/001 2011-11-28, EU/1/11/737/002 20111128
1632232	SPC/GB17/008	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
1663240	PA2015038	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128

Market Dynamics and Financial Trajectory for Rilpivirine Hydrochloride

Last updated: August 12, 2025

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Introduction

Rilpivirine hydrochloride (Rilpivirine, RPV) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved primarily for the treatment of HIV-1 infections. Since its FDA approval in 2011, the drug has established a notable position within antiretroviral therapy (ART) regimens due to its efficacy, safety profile, and convenient dosing schedule. As the landscape of HIV treatment evolves, understanding the market dynamics and financial trajectory of Rilpivirine HCl offers valuable insights for stakeholders ranging from pharmaceutical companies to healthcare investors.

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Market Overview

The global HIV therapeutics market, estimated at USD 30 billion in 2022, continues to expand due to increasing HIV prevalence, aging populations, and advances in treatment options. Rilpivirine's role within this market remains significant, especially as it is incorporated into combination formulations, notably with emtricitabine and tenofovir disoproxil fumarate (e.g., Juluca, a fixed-dose combination), which enhances patient adherence and simplifies regimens.

Rilpivirine is predominantly marketed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, with geographic availability spanning North America, Europe, and parts of Asia. The drug's market share fluctuates based on competition, pricing, patents, and the advent of newer agents.

Key competitive advantages:

• Favorable safety profile, particularly fewer neuropsychiatric side effects compared to efavirenz.
• Once-daily oral dosing enhances patient compliance.
• Resistance profile allows use in certain treatment-naïve populations.

Market challenges:

• Reduced efficacy among patients with high viral loads or in certain resistant strains.
• Competition from newer agents with better resistance profiles, such as doravirine.
• Patent expirations leading to increased generic availability could pressure pricing and margins.

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Market Dynamics Influencing Rilpivirine's Trajectory

1. Patent Life and Generic Competition

Rilpivirine’s patent expiration, expected around 2028–2030 in key markets, will significantly impact its revenue streams. Introduction of generic versions usually results in price erosion and market share redistribution. Wholesale and retail markets are yet to see substantial generics, but anticipation influences strategic R&D investments.

2. Advancements in HIV Therapeutics

The emergence of novel NNRTIs such as doravirine and integrase strand transfer inhibitors (INSTIs) like bictegravir have begun to supplant Rilpivirine in certain treatment protocols, especially given their superior resistance profiles and broader patient applicability.

Moreover, combination therapies are shifting toward fixed-dose combinations (FDCs). Rilpivirine's integration into second- and third-generation combo pills influences its market receptiveness.

3. Regulatory and Political Factors

Approval extensions, label updates, and screening for resistance patterns influence market penetration. Additionally, access disparities in low-income nations constrain growth, though global initiatives like the Global Fund aim to improve distribution.

4. Pricing Strategies and Reimbursement Policies

Pricing remains a critical determinant. Rilpivirine's cost-effectiveness compared to newer agents influences formulary placements. Reimbursement policies in key markets, such as the U.S. and Europe, significantly impact sales volumes.

5. COVID-19 Pandemic Effect

The pandemic shifted healthcare priorities, causing delays in routine testing and prescription renewals. Though temporary, these effects could influence short-term sales dynamics.

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Financial Trajectory Analysis

Revenue Projections

Janssen reported Rilpivirine's peak sales reaching approximately USD 600 million globally in the mid-2010s. While in decline due to market competition and patent expiry, the drug continues generating substantial revenue through existing patent protections and inclusion in combination therapies.

Forecasts suggest a compound annual growth rate (CAGR) of approximately -2% to -4% between 2023 and 2030, mainly driven by patent expiration and replacement by newer agents. However, with strategic positioning in low- and middle-income markets and ongoing clinical trial results supporting broader indications, revenues may stabilize or experience modest growth within specific niches.

R&D and Investment Outlook

Pharmaceutical companies continue Rilpivirine-related R&D to extend patent life, develop improved formulations (including long-acting injectables), and identify new therapeutic combinations. For instance, Janssen's development of long-acting injectable formulations aims to capitalize on adherence advantages, potentially revitalizing the Rilpivirine market segment.

Market Expansion Potential

Emerging markets present significant growth potential, with increasing HIV prevalence in regions like sub-Saharan Africa and Southeast Asia. Strategic alliances, differential pricing, and patent licensing can facilitate entry, augmenting revenue streams.

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Strategic Opportunities and Risks

Opportunities:

• Development of Long-acting Formulations: Enhances treatment adherence and patient convenience, opening new market segments.
• Combination with Innovative Agents: Inclusion in next-generation FDCs can reinforce its clinical relevance.
• Expansion into Treatment-Naïve Populations: Clinical trials demonstrating efficacy in diverse populations can boost adoption.

Risks:

• Patent Expiry and Generic Competition: Erode profit margins unless offset by new formulations or indications.
• Evolving Treatment Guidelines: Favoring agents with broader resistance profiles and safety margins.
• Pricing Pressures and Reimbursement Limitations: Particularly in cost-sensitive markets.

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Conclusion

Rilpivirine hydrochloride continues to be a significant component of HIV treatment regimens with a stable, albeit declining, revenue trajectory. Its market dynamics are heavily influenced by patent protections, competition from newer agents, and evolving treatment paradigms. The financial outlook hinges on strategic innovation, such as long-acting formulations and combination therapies, alongside effective market access strategies.

By positioning itself within the context of emerging therapies and addressing patent and pricing challenges, Rilpivirine can sustain its market relevance and profitability for the foreseeable future.

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Key Takeaways

• Rilpivirine’s revenue is projected to decline modestly post-patent expiry unless it is supported by new formulations or indications.
• Development of long-acting injectable formulations could rejuvenate its market presence.
• Competition from agents like doravirine and advances in integrase inhibitors is reshaping the HIV therapeutic landscape.
• Expansion into emerging markets and partnerships can mitigate revenue erosion due to generic competition.
• Strategic positioning within combination therapies remains essential for sustained market relevance.

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FAQs

1. When is Rilpivirine hydrochloride expected to face significant generic competition?
Generic versions are anticipated around 2028–2030, contingent upon patent legislative timelines in key markets.

2. How does Rilpivirine compare to newer NNRTIs in terms of efficacy and safety?
Rilpivirine offers a favorable safety profile but may be less effective in patients with resistance mutations or high viral loads compared to agents like doravirine.

3. What innovations could potentially revive Rilpivirine’s market share?
Development of long-acting injectable formulations and inclusion in new fixed-dose combination therapies are promising strategies.

4. How significant is Rilpivirine’s role in the global HIV treatment landscape?
While innovative agents and generics impact market share, Rilpivirine remains relevant within specific populations and treatment regimens.

5. What are the risks associated with investing in Rilpivirine's future?
Patent expiration, stiff competition, and evolving clinical guidelines pose risks to sustained profitability.

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References:

[1] Global HIV Therapeutics Market Report, 2022.
[2] Janssen Pharmaceuticals Rilpivirine Product Information, 2023.
[3] ClinicalTrials.gov Database.
[4] Industry Analysis: HIV Drugs, 2023.