ISENTRESS HD Drug Patent Profile

Which patents cover Isentress Hd, and what generic alternatives are available?

Isentress Hd is a drug marketed by Msd Sub Merck and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has ninety patent family members in forty-one countries.

The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Isentress Hd

A generic version of ISENTRESS HD was approved as raltegravir potassium by LUPIN LTD on May 6^th, 2025.

Summary for ISENTRESS HD

International Patents:	90
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	88
Patent Applications:	347
Drug Prices:	Drug price information for ISENTRESS HD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ISENTRESS HD
DailyMed Link:	ISENTRESS HD at DailyMed

See drug prices for ISENTRESS HD

Recent Clinical Trials for ISENTRESS HD

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

Sponsor	Phase
Canadian Institutes of Health Research (CIHR)	Phase 2
Unity Health Toronto	Phase 2
St. Michael's Hospital, Toronto	Phase 2

See all ISENTRESS HD clinical trials

Pharmacology for ISENTRESS HD

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors

Paragraph IV (Patent) Challenges for ISENTRESS HD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ISENTRESS HD	Tablets	raltegravir potassium	600 mg	022145	1	2022-10-21
ISENTRESS HD	Tablets	raltegravir potassium	400 mg	022145	1	2011-10-12

US Patents and Regulatory Information for ISENTRESS HD

ISENTRESS HD is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	AB	RX	Yes	Yes	8,771,733		Y	Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	AB	RX	Yes	Yes	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	AB	RX	Yes	Yes	10,772,888
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	AB	RX	Yes	Yes	9,649,311*PED				Y

Expired US Patents for ISENTRESS HD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	7,169,780*PED
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	7,435,734*PED
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	7,217,713*PED

International Patents for ISENTRESS HD

See the table below for patents covering ISENTRESS HD around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	2493312
Norway	2008007
Spain	2898348
Japan	5228488
Slovenia	1819700

Supplementary Protection Certificates for ISENTRESS HD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	PA2008007,C1441735	Lithuania		PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
1441735	0890018-5	Sweden		PRODUCT NAME: RALTEGRAVIR
1441735	91428	Luxembourg		PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080102
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1441735	C20080001 00016	Estonia		PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801

Market Dynamics and Financial Trajectory for ISENTRESS HD

Last updated: July 28, 2025

Introduction

ISENTRESS HD (raltegravir, 1200 mg) is an advanced formulation of Merck's (MSD) antiretroviral therapy (ART), primarily indicated for HIV-1 infection management. As the latest iteration in the ISENTRESS line, designed for once-daily high-dose administration, ISENTRESS HD aims to enhance patient adherence, reduce pill burden, and improve treatment outcomes. Its introduction and subsequent market performance are subject to evolving HIV treatment paradigms, competitive landscapes, regulatory influences, and market demand dynamics.

Market Landscape and Patient Demographics

The global HIV treatment market is mature but continually evolving, driven by increasing access to healthcare, advancements in ART, and the persistent global burden of HIV/AIDS. As of 2023, approximately 38 million individuals worldwide live with HIV, with around 28 million on antiretroviral therapy.[1] The dominant regimens combine integrase inhibitors (INIs) like raltegravir, dolutegravir, and bictegravir, owing to their efficacy and tolerability.

The segment of integrase strand transfer inhibitors (INSTIs) remains highly competitive with some key players: Gilead Sciences' bictegravir, ViiV Healthcare's dolutegravir, and Merck's raltegravir formulations. ISENTRESS HD specifically targets patients who prefer simplified regimens with once-daily dosing, aligning with the broader trend toward minimal pill burden to enhance adherence, particularly in resource-limited settings.

Market Dynamics Influencing ISENTRESS HD

Regulatory Approvals and Launch Timeline

Merck received FDA approval for ISENTRESS HD in 2018, building upon the established efficacy of raltegravir.[2] Notably, this formulation received accelerated approval based on its non-inferiority and safety profile compared to standard raltegravir regimens. Regulatory endorsements in Europe and other regions followed sequentially, expanding accessibility.

Competitive Positioning

ISENTRESS HD entered a high-growth environment dominated by growing preference for INSTI-based regimens. Its main competitors—Gilead's Biktarvy (bictegravir/emtricitabine/tenofovir) and ViiV's Tivicay (dolutegravir)—offer fixed-dose combinations with once-daily dosing, often incorporating NRTIs for complete regimens.[3] These combinations have secured significant market share due to convenience and high efficacy.

While ISENTRESS HD's monotherapy or dual therapy approach may limit its use compared to all-in-one formulations, it remains relevant in specific contexts such as salvage therapy, treatment simplification for stable patients, or where resistance issues preclude certain agents.

Market Adoption Drivers

• Adherence and Simplification: The shift toward once-daily dosing bolsters the appeal of ISENTRESS HD in improving long-term adherence.
• Treatment Guidelines Alignment: Major guidelines (e.g., DHHS, EACS) recommend integrase inhibitors as first-line options, indirectly supporting ISENTRESS HD's market potential.
• Patient Subpopulations: Usage is concentrated among treatment-experienced patients, those with resistance concerns, or cases where NRTI-sparing regimens are preferred.

Pricing and Reimbursement Policies

Pricing strategies substantially influence market penetration. Merck positions ISENTRESS HD at a competitive price point relative to fixed-dose combinations, sometimes offset by value propositions like reduced pill burden.[4] Reimbursement and formulary inclusion are vital for uptake, particularly in institutional and national healthcare systems.

Patent Landscape and Generic Competition

Merck holds key patents protecting raltegravir formulations until mid-2020s, although patent cliffs pose a future threat. The entry of generics may erode revenue streams, particularly in low- and middle-income countries where generics dominate.

Emerging Market Trends and Future Outlook

Innovations in long-acting injectable ART (e.g., cabotegravir/rilpivirine) are poised to reshape the HIV treatment landscape.[5] These modalities could diminish demand for oral regimens like ISENTRESS HD, especially among populations prioritizing convenience.

Financial Trajectory and Revenue Forecast

Historical Performance

Since its launch, ISENTRESS HD contributed to Merck's HIV franchise revenues, which peaked prior to generic entry of raltegravir in some regions. In 2020, Merck reported that raltegravir-based products generated approximately $1.2 billion globally, with ISENTRESS HD capturing a significant share due to its convenience factor.[6] However, recent declines have been observed due to increasing competition and patent expirations.

Projected Revenue Streams

• Short-term (2023–2025): Steady but plateauing revenues, driven by existing patient base and off-label use. Marginal growth expected in high-income countries due to guideline-driven prescribing.
• Mid- to Long-term (2025–2030): Potential revenue decline due to generic competition and emerging long-acting therapies. However, niche applications and strategic positioning could sustain steady income streams.
• Growth Opportunities: Expansion into developing markets with tailored pricing, strategic alliances for combination therapies, and potential in salvage therapy applications.

Key Factors Affecting Financial Trajectory

• Pipeline and Formulation Innovations: Development of novel combinations or long-acting formulations.
• Regulatory Approvals: Expanded indications or new formulations.
• Market Penetration and Reimbursement: Payer acceptance and formulary inclusion.
• Competitive Dynamics: Success of new entrants and generics.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Need to diversify portfolios with innovative formulations, including long-acting injectables, to sustain revenues.
• Investors: Closely monitor patent timelines, emerging therapies, and guideline changes to assess long-term viability.
• Healthcare Providers: Evaluate cost-effectiveness, adherence benefits, and patient-specific factors when selecting regimens involving ISENTRESS HD.
• Policy Makers: Facilitate access through favorable reimbursement policies, especially in resource-constrained settings.

Key Challenges and Opportunities

Challenges

• The impending patent expiration threatens revenue stability.
• Competition from combination products offering superior convenience.
• Rapid evolvement of long-acting injectable formulations reducing oral therapy demand.

Opportunities

• Positioning ISENTRESS HD as a flexible component in tailored regimens.
• Expanding into emerging markets with affordable pricing.
• Leveraging real-world data to highlight adherence benefits.

Conclusion

The market dynamics for ISENTRESS HD encapsulate a landscape characterized by innovation, fierce competition, and shifting treatment paradigms. While current revenues benefit from its efficacy and convenience, future growth hinges on strategic positioning amidst patent expirations, emerging therapies, and evolving guidelines. The key for stakeholders lies in leveraging its strengths in targeted niches while preparing for a transformative market influenced increasingly by long-acting regimens.

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Key Takeaways

• Market Position: ISENTRESS HD maintains relevance in specific niches within a competitive HIV treatment landscape, driven by once-daily dosing and adherence benefits.
• Revenue Outlook: Short-term stability but long-term decline risk exists due to patent expirations and emerging long-acting therapies.
• Strategic Focus: Diversification into combination products, geographic expansion, and adaptation to novel treatment modalities are critical.
• Competitive Threats: Long-acting injectable formulations and generic entries pose notable challenges.
• Stakeholder Engagement: Payers, providers, and policymakers influence its market trajectory through coverage decisions and access programs.

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FAQs

1. How does ISENTRESS HD differ from standard raltegravir formulations?
ISENTRESS HD delivers a higher dose (1200 mg) once daily, simplifying dosing schedules. It aims to improve adherence relative to the standard 400 mg twice-daily regimen, particularly for treatment-experienced patients, by reducing pill burden.

2. What are the main competitors to ISENTRESS HD in the HIV market?
Primarily, Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir) and ViiV’s Tivicay (dolutegravir) offer fixed-dose, once-daily regimens that incorporate multiple agents, providing convenience and broad efficacy. Long-acting injectables like cabotegravir/rilpivirine also threaten oral regimens' dominance.

3. What is the impact of patent expiration on ISENTRESS HD’s financial prospects?
Patent expiry leads to generic competition, significantly reducing pricing power and sales volume. Merck’s patent protections are expected to last until the mid-2020s, after which generic raltegravir products will likely erode revenues.

4. Are there any new developments or formulations planned for ISENTRESS HD?
While Merck continues to focus on long-acting formulations and combination therapies, specific updates on new ISENTRESS HD formulations are limited. The company emphasizes innovation in the broader HIV franchise.

5. How significant is the role of emerging long-acting therapies in the future of ISENTRESS HD?
Long-acting injectable ART exemplifies a shift toward less frequent dosing, potentially diminishing demand for daily oral pills like ISENTRESS HD. The ongoing clinical approval and adoption of these therapies could markedly impact its market share.

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Sources:
[1] UNAIDS. Global HIV & AIDS statistics.
[2] U.S. Food and Drug Administration. FDA approves new formulation of HIV drug. 2018.
[3] DHHS Guidelines for the Use of Antiretroviral Agents. 2023.
[4] Merck Annual Report. 2022.
[5] FDA. Long-Acting Injectable Cabotegravir for HIV. 2021.
[6] Merck Financial Reports. 2020.