DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE - Generic Drug Details

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

Dolutegravir sodium; rilpivirine hydrochloride is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium; rilpivirine hydrochloride has five hundred and twenty-one patent family members in fifty-eight countries.

One supplier is listed for this compound.

Summary for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

International Patents:	521
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	51
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
DailyMed Link:	DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

10,426,780

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.

Pharmacology for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

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

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JULUCA	Tablets	dolutegravir sodium; rilpivirine hydrochloride	50 mg/25 mg	210192	1	2019-11-19

US Patents and Regulatory Information for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	10,426,780		Y	Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	12,011,506		Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	7,125,879		Y	Y

Expired US Patents for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017	6,838,464
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017	8,080,551
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017	8,101,629

International Patents for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2009325128
Norway	2016025
Russian Federation	2638923	Синтез карбамоилпиридоновых ингибиторов интегразы ВИЧ и промежуточных соединений (SYNTHESIS OF CARBAMOIL-PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)

Supplementary Protection Certificates for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	19/2012	Austria		PRODUCT NAME: RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBARE ADDITIONSSALZE VON RILPIVIRIN, ENSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 (MITTEILUNG) 20111130
1874117	PA2014021,C1874117	Lithuania		PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116
1663240	1690062-3	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623

Market Dynamics and Financial Trajectory for Dolutegravir Sodium and Rilpivirine Hydrochloride

Last updated: July 28, 2025

Introduction

Dolutegravir sodium and rilpivirine hydrochloride occupy a critical space within the HIV therapeutic landscape. As components of combination antiretroviral therapy (ART), these drugs exemplify the shift toward potent, well-tolerated, and once-daily regimens. Their market trajectories are shaped by evolving clinical preferences, regulatory environments, competitive innovations, and global health initiatives. This analysis explores the current market landscape and forecasts the financial outlooks for these two drugs over the coming years.

Market Overview

Dolutegravir Sodium: The Market Leader in INSTI Class

Dolutegravir (DTG), a selective integrase strand transfer inhibitor (INSTI), has emerged as a cornerstone in HIV treatment, especially after its approval by the U.S. Food and Drug Administration (FDA) in 2013. Its high barrier to resistance, efficacy, and favorable safety profile have driven widespread adoption globally. Major manufacturers, including ViiV Healthcare (a GSK-Pfizer alliance), Merck, and others, have launched fixed-dose combinations (FDCs) featuring DTG, such as Triumeq and Juluca.

The drug's global reach is reinforced by WHO guidelines recommending INSTI-based regimens as first-line therapy in low- and middle-income countries (LMICs). This has significantly expanded market access beyond traditional high-income markets, fueling growth in Africa, Asia, and Latin America.

Rilpivirine Hydrochloride: A Next-Generation NNRTI

Rilpivirine (RPV), introduced in 2011 by Janssen Pharmaceuticals, is a non-nucleoside reverse transcriptase inhibitor (NNRTI), positioned as a preferred option within certain ART regimens. Its improved tolerability profile over older NNRTIs, such as efavirenz, has bolstered its clinical use. RPV's inclusion in FDCs like Complera and Edurant has contributed to its market penetration.

Despite its advantages, rilpivirine faces challenges from newer agents like DTG, especially as the latter demonstrates superior resistance profiles and compatibility with simplified regimens.

Market Drivers

1. Expanding Global HIV Treatment Need

An estimated 38 million people worldwide live with HIV, with annual new infections exceeding 1.5 million (UNAIDS, 2022). Increased access to ART, particularly in LMICs, drives demand for effective, affordable, and tolerable drugs like DTG and RPV.

2. Favorable Regulatory and Policy Environment

WHO's endorsement of DTG as the preferred first-line therapy catalyzes market expansion. Similarly, national treatment guidelines in countries across Africa, Asia, and Latin America prioritize INSTI-based regimens, reinforcing demand.

3. Product Innovation and Fixed-Dose Combinations

The development of combination pills improves patient adherence and simplifies treatment, boosting sales. Notable examples include trictegravir-based products and dual agents with RPV, expanding the market scope.

4. Patent Expirations and Generic Competition

Patent expiration timelines influence market prices and accessibility. For instance, the patent cliff for certain formulations of rilpivirine may facilitate generic entry in key markets, impacting revenue trajectories.

5. Competitive Landscape and Emerging Therapies

Advancements in long-acting injectable ART, such as cabotegravir and rilpivirine formulations, are poised to reshape the market landscape by offering less frequent dosing options, thus competing directly with oral regimens.

Market Challenges

1. Resistance and Efficacy Concerns

While DTG's high resistance barrier secures its prominence, emerging resistant strains can threaten its dominance. Rilpivirine's efficacy diminishes in cases of pre-existing resistance to NNRTIs, limiting its patient pool.

2. Safety and Tolerability Profile

Adverse effects such as weight gain with DTG and mood disorders with rilpivirine impact patient and clinician preferences, potentially influencing prescribing patterns.

3. Pricing and PATENTLANDSCAPE

Pricing strategies, especially in LMICs, significantly impact access and revenue. Patent protections restrict generic competition in some regions, while patent expiries open opportunities elsewhere.

4. Regulatory Hurdles and Market Access

Regional regulatory delays and complex approval processes can hinder timely commercialization of new formulations, constraining revenue growth.

Financial Trajectory Analysis

Current Revenue Status

• Dolutegravir: The global market for DTG-based products was valued at approximately USD 3.8 billion in 2022, with growth rates estimated at 10-15% annually, driven by increased adoption and expanded geographic market penetration (IQVIA, 2022).

• Rilpivirine: Rilpivirine's standalone global sales in 2022 are estimated at USD 600 million, with growth stabilizing or declining modestly due to competition from integrase inhibitors and long-acting injectables.

Forecasted Revenue Trends

• Dolutegravir Sodium: Projected compound annual growth rate (CAGR) of 8-12% through 2028. Increasing access in LMICs, approvals of new fixed-dose combinations, and potential inclusion in long-acting regimens will sustain revenue streams. Market expansion into pediatric formulations and maintenance of dominance in first-line therapies will underpin growth.

• Rilpivirine Hydrochloride: Anticipated CAGR of approximately 2-5% in the short term, primarily driven by off-patent status in certain regions fostering generic manufacturing. However, long-term growth prospects are limited by the advent of more effective, tolerable, and long-acting agents.

Impact of Emerging Technologies

Long-acting injectable regimens, notably cabotegravir and rilpivirine (approved in 2021), are projected to capture a significant share of the market by offering monthly or quarterly dosing options. This technological shift can reduce oral medication sales for rilpivirine but simultaneously create new revenue streams for its injectable formulations.

Market Entry and Competition

Generic entrants will pressure pricing, especially for rilpivirine in regions where patent protections lapse. Conversely, patent protection and strategic partnerships might enable firms to extend exclusivity for DTG-based products, maintaining revenue streams.

Regulatory and Policy Influences

Global health initiatives and funding mechanisms like Gilead's PEPFAR and the Global Fund, along with regulatory approvals in emerging markets, will continue to shape the financial trajectory by enhancing accessibility.

Conclusion

The market dynamics for dolutegravir sodium are characterized by strong growth prospects, driven by its clinical advantages and global treatment policies favoring INSTI-based regimens. The transition toward long-acting injectable formulations presents both challenges and opportunities, potentially sustaining growth for innovative delivery platforms. Rilpivirine hydrochloride faces a more competitive landscape, with growth constrained by newer agents and the transition toward long-acting therapies, though its cost-effective generics can ensure steady revenue streams in select markets.

Key Takeaways

• Dolutegravir's dominance in the HIV treatment market is expected to persist, supported by high efficacy, resistance profile, and broad regulatory support, with projected revenues sustaining growth at 8-12% CAGR through 2028.

• Market expansion in LMICs, facilitated by WHO guidelines and global health programs, will be pivotal for long-term revenue outlooks for both drugs.

• Emerging long-acting injectable formulations pose a disruptive influence, potentially rechanneling revenues from oral to injectable segments, especially for rilpivirine.

• Generic competition post-patent expiry will exert downward pressure on prices, particularly impacting rilpivirine's revenue streams.

• Strategic patent management and pipeline development will be vital for pharmaceutical firms seeking to sustain or enhance market share.

FAQs

1. How will long-acting injectable formulations influence the market for rilpivirine?
Long-acting injectables like Cabotegravir/Rilpivirine are poised to reduce demand for oral rilpivirine, shifting revenue towards injectable formulations. However, they also offer new revenue opportunities by expanding treatment options and market penetration.

2. What role do global health initiatives play in the market for these drugs?
WHO guidelines and funding programs like PEPFAR significantly facilitate access to dolutegravir-based regimens in LMICs, expanding market size and sustaining demand in resource-constrained regions.

3. Are there concerns regarding resistance that could impact future demand?
Yes. Resistance development, particularly in cases of treatment failure or suboptimal adherence, could affect drug effectiveness and market share, especially for rilpivirine which has a lower barrier to resistance.

4. What is the outlook for generic versions of rilpivirine in emerging markets?
Patent expiries in key countries will likely enable the entry of generics, leading to price reductions and increased accessibility, potentially stabilizing or modestly increasing sales volumes.

5. How might regulatory changes impact the market for these drugs?
Streamlined approval processes and inclusion in national treatment guidelines will facilitate faster market entry and broader use, boosting revenues. Conversely, delays or restrictions could hinder growth.

References
[1] UNAIDS. (2022). Global HIV & AIDS statistics.
[2] IQVIA. (2022). HIV/AIDS therapeutics pipeline and market analysis.