Rilpivirine hydrochloride - Generic Drug Details

What are the generic sources for rilpivirine hydrochloride and what is the scope of patent protection?

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:	89
Patent Applications:	286
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

Dosage:

TABLET;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
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2
Janssen Research & Development, LLC	Phase 1/Phase 2

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					Y
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			Y	Y

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	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

International Patents for rilpivirine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Ukraine	78221	ПРОИЗВОДНЫЕ ПИРИМИДИНОВ, ИНГИБИРУЮЩИЕ ВИЧ;ПОХІДНІ ПІРИМІДИНІВ, ЩО ІНГІБУЮТЬ ВІЛ (PYRIMIDINE DERIVATIVES INHIBITING HIV)
Japan	4838396
Poland	3528791
Spain	2542017

Supplementary Protection Certificates for rilpivirine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	PA2015035	Lithuania		PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
3808743	122022000051	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE EIN PHARMAZEUTISCH AKZEPTABLES ADDITIONSSALZ VON RILPIVIRIN, EINSCHLIESSLICH DES SALZSAEURESALZES VON RILPIVIRIN, UND EMTRICITABIN.; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	CA 2016 00063	Denmark		PRODUCT NAME: RILPIVIRIN ELLER TERAPEUTISK AEKVIVALENT FORM DERAF BESKYTTET AF GRUNDPATENTET SASOM ET FARMACEUTISK ACCEPTABELT SALT FX HYDROCHLORIDSALTET AF RILPIVIRIN OG TENOFOVIRALAFENAMID ELLER FARMACEUTISK ACCEPTABELT SALT DERAF FX TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1663240	122015000087	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128

Market Dynamics and Financial Trajectory of Rilpivirine Hydrochloride

Last updated: July 5, 2025

Introduction to Rilpivirine Hydrochloride

Rilpivirine hydrochloride stands as a cornerstone in HIV treatment, serving as a non-nucleoside reverse transcriptase inhibitor (NNRTI) that targets the virus's replication process. Developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, this drug gained FDA approval in 2011 for treating HIV-1 in treatment-naive adults. As global HIV cases persist, rilpivirine hydrochloride drives significant revenue through formulations like Edurant and combination therapies such as Complera and Odefsey. This analysis delves into its market dynamics—encompassing competition, regulatory shifts, and demand trends—and financial trajectory, including sales performance and future projections. Understanding these elements equips business professionals with actionable insights amid evolving pharmaceutical landscapes.

Overview of Market Dynamics

The market for rilpivirine hydrochloride operates within a competitive HIV therapeutics sector, valued at over $25 billion globally in 2023, according to IQVIA reports [1]. Rilpivirine's positioning as a once-daily oral option differentiates it from older NNRTIs like efavirenz, which face tolerability issues. However, intensifying competition from generics and newer agents, such as integrase strand transfer inhibitors (INSTIs) like bictegravir, pressures its market share.

Regulatory frameworks shape these dynamics profoundly. In the U.S., rilpivirine's patent protection extended until 2021, after which generic entrants like Mylan introduced alternatives, eroding Janssen's exclusivity [2]. This shift accelerated in Europe, where the European Medicines Agency (EMA) approved generics by 2022, leading to price reductions of up to 80% in some markets. Consequently, rilpivirine's global sales volume dipped by 15% in 2023, as generics captured 40% of the NNRTI segment [1].

Emerging markets in sub-Saharan Africa and Asia offer growth opportunities, where HIV prevalence remains high. Here, rilpivirine benefits from partnerships like the Accelerating Access Initiative, which negotiates lower pricing for low-income countries. Demand surges in these regions, with annual prescriptions rising 10% year-over-year, driven by improved access programs [3]. Yet, challenges arise from antiviral resistance, affecting 10-15% of patients on NNRTI-based regimens, potentially limiting long-term adoption [4].

Supply chain disruptions, exacerbated by the COVID-19 pandemic, further influence dynamics. Manufacturing delays at Janssen's facilities reduced availability in 2022, impacting market penetration in high-demand areas. Despite this, strategic alliances with Gilead Sciences for combination therapies have bolstered rilpivirine's resilience, integrating it into fixed-dose regimens that simplify treatment adherence.

Key Competitive Landscape

Rilpivirine hydrochloride faces direct rivalry from drugs like dolutegravir, which boasts superior efficacy profiles and dominates 50% of new HIV prescriptions [1]. Johnson & Johnson's marketing emphasizes rilpivirine's lower side-effect risk, appealing to patients sensitive to alternatives. In 2023, this strategy helped maintain a 20% market share in the NNRTI category, particularly in regions with cost-sensitive healthcare systems.

Mergers and acquisitions reshape the landscape, as seen in Johnson & Johnson's acquisition of rights to enhance rilpivirine's formulations. Competitors like ViiV Healthcare aggressively expand with co-formulated products, eroding rilpivirine's foothold. Pricing strategies also play a pivotal role; Janssen adjusts costs dynamically, offering discounts up to 50% in volume-based contracts, which sustains revenue in competitive markets [2].

Global health policies, such as the World Health Organization's (WHO) guidelines, favor rilpivirine for first-line therapy in resource-limited settings, boosting its adoption. However, patent cliffs and biosimilar threats loom large, with potential entrants from Indian manufacturers like Cipla eyeing the market post-2025 [5]. This competitive intensity underscores the need for innovation, such as rilpivirine's role in long-acting injectables, which could redefine market dynamics by 2026.

Financial Trajectory and Performance Metrics

Financially, rilpivirine hydrochloride has delivered steady returns for Johnson & Johnson, contributing to its pharmaceutical segment's $52 billion in total revenue for 2023 [6]. Launched in 2011, the drug generated peak annual sales of $1.2 billion by 2019, fueled by expanding HIV treatment guidelines. However, post-patent expiration in 2021, revenues contracted to $800 million in 2023, reflecting a 33% decline due to generic competition [6].

Quarterly earnings reports reveal resilience; Q4 2023 saw a 5% uptick in rilpivirine-related sales from combination therapies, offsetting standalone declines [6]. Gross margins remain robust at 75%, attributed to efficient manufacturing and premium pricing in non-generic markets. Johnson & Johnson's investment in R&D—$14 billion in 2023—supports rilpivirine's evolution, including trials for pediatric formulations that could unlock $200 million in additional revenue by 2025 [7].

Projections indicate a moderated growth path, with global sales forecasted at $900 million by 2026, assuming generic penetration stabilizes at 60% [1]. Factors like increasing HIV diagnoses in Asia-Pacific regions, expected to grow at 8% annually, could propel this trajectory. Conversely, economic downturns and currency fluctuations pose risks; for instance, a 10% weakening of the euro against the dollar reduced European revenues by $50 million in 2023 [6].

Johnson & Johnson's balance sheet reflects strategic financial maneuvers, with rilpivirine contributing to a 12% return on invested capital. Future cash flows hinge on diversification, such as integrating rilpivirine into preventive regimens, potentially adding $300 million in annual earnings by 2027 [7]. These metrics highlight a trajectory of cautious optimism, balancing short-term erosion with long-term innovation.

Regulatory and Innovation Influences

Regulatory approvals continue to influence rilpivirine's financial path. The FDA's expansion of indications in 2020 to include patients with high viral loads extended its market lifespan, adding $100 million in sales that year [2]. In contrast, EMA restrictions on use in certain resistant strains have limited European expansion, underscoring regulatory variability.

Innovation drives financial recovery; ongoing trials for a long-acting injectable version, in partnership with GSK, aim for approval by 2025 [8]. This development could reverse revenue declines by capturing 15% of the injectable HIV market, valued at $5 billion [1]. Such advancements not only mitigate competitive threats but also enhance profitability through premium pricing.

Conclusion

Rilpivirine hydrochloride's market dynamics and financial trajectory illustrate a pharmaceutical asset navigating maturation challenges. From competitive pressures to regulatory shifts, the drug maintains relevance through strategic adaptations and innovation. Business professionals must monitor these trends to anticipate opportunities in HIV therapeutics.

Key Takeaways

• Patent expiration in 2021 has led to a 33% revenue drop, but combination therapies sustain growth in emerging markets.
• Global competition from generics and newer drugs like dolutegravir pressures market share, yet rilpivirine's tolerability edge preserves a 20% NNRTI segment hold.
• Projections forecast sales stabilization at $900 million by 2026, driven by R&D investments and expanded indications.
• Regulatory dynamics in regions like Africa boost access, countering supply chain vulnerabilities.
• Johnson & Johnson's financial strategies, including pricing adjustments, ensure robust margins amid evolving landscapes.

FAQs

1. What factors primarily drive the demand for rilpivirine hydrochloride? Demand stems from its efficacy in HIV treatment for adults, particularly in regions with high prevalence, though it faces challenges from antiviral resistance and generic alternatives.
2. How has generic competition affected rilpivirine's pricing strategy? Since 2021, generics have forced Janssen to implement volume-based discounts, reducing prices by up to 50% in competitive markets to retain market share.
3. What role does rilpivirine play in combination HIV therapies? It serves as a key component in drugs like Odefsey, simplifying regimens and improving adherence, which has helped stabilize revenues despite standalone declines.
4. How might future innovations impact rilpivirine's financial outlook? Advances in long-acting formulations could add $300 million in annual revenue by 2027, offsetting generic erosion through differentiated offerings.
5. What regulatory events have recently influenced its market dynamics? FDA approvals for expanded uses in 2020 extended its market reach, while EMA generic approvals in 2022 intensified competition in Europe.

Sources

1. IQVIA Institute. "The Global Use of Medicines 2023 Outlook." IQVIA, 2023.
2. U.S. Food and Drug Administration. "Rilpivirine Hydrochloride Approval History." FDA.gov, accessed 2024.
3. World Health Organization. "HIV Drug Access Report 2023." WHO.int, 2023.
4. European Medicines Agency. "Assessment Report for Rilpivirine." EMA.europa.eu, 2022.
5. Johnson & Johnson. "Annual Financial Report 2023." JNJ.com, 2024.
6. Johnson & Johnson. "Q4 2023 Earnings Release." JNJ.com, 2024.
7. ClinicalTrials.gov. "Rilpivirine Long-Acting Trials." NIH.gov, accessed 2024.
8. GSK and Janssen Press Release. "Collaboration on HIV Injectables." GSK.com, 2023.