ISENTRESS HD Drug Patent Profile

Which patents cover Isentress Hd, and when can generic versions of Isentress Hd launch?

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
Unity Health Toronto	Phase 2
St. Michael's Hospital, Toronto	Phase 2
Canadian Institutes of Health Research (CIHR)	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	7,217,713*PED
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	7,435,734*PED

International Patents for ISENTRESS HD

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1819323	COMPOSITION PHARMACEUTIQUE RENFERMANT UN AGENT D'ANTI-NUCLEATION (PHARMACEUTICAL COMPOSITION CONTAINING AN ANTI-NUCLEATING AGENT)
Spain	2755273
Hungary	S1600016
Poland	369223
Taiwan	I344463

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	C300340	Netherlands		PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735	91428	Luxembourg		PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080102
1441735	300340	Netherlands		PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20080102
1441735	30/2008	Austria		PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436 (MITTEILUNG) 20071220

Market Dynamics and Financial Trajectory for ISENTRESS HD

Last updated: December 27, 2025

Executive Summary

Isentress HD (high-dose formulation of Raltegravir) is an antiretroviral drug developed by Merck & Co. targeting HIV-1 infection. Launched primarily for adult patients requiring intensified viral suppression, Isentress HD faces complex market dynamics driven by evolving HIV treatment protocols, competitive landscape, patent protections, and regulatory considerations. This report offers an in-depth analysis of the current market environment, projected financial trajectory, competitive positioning, and strategic implications.

Introduction

Isentress HD represents an extension of Merck’s integrase inhibitor portfolio, providing a higher dosage (600 mg BID) compared to the standard 400 mg BID formulation. This product’s development aligns with the demand for simplified regimens and increased efficacy in resistant or heavily treatment-experienced populations.

This report consolidates market data, sales trends, pipeline updates, and regulatory insights to forecast the product’s financial performance over the next five years.

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What Are the Key Market Drivers for Isentress HD?

Driver	Impact	Details
HIV Prevalence & Incidence	Growth	Approximately 38 million people globally living with HIV, with annual new infections around 1.5 million (UNAIDS, 2022). The expanding patient pool fuels demand for effective ART options.
Treatment Guidelines & Adoption	Positive	WHO, CDC, and EACS guidelines favor integrase inhibitors as first-line therapy, supporting uptake. High-dose options appeal to specific subpopulations like heavily resistant cases.
Resistance Management & Tolerance	Increased Demand	Higher-dose regimens cater to patients with suboptimal viral suppression or resistance. Management of resistant HIV strains justifies higher-dose formulations.
Pricing & Reimbursement Policies	Variable	Premium pricing is feasible due to clinical benefits, but reimbursement hurdles in emerging markets and price competition from generics temper growth.
Competitive Landscape	Challenging	Competition from other integrase inhibitors (e.g., Dolutegravir, Bictegravir) and fixed-dose combinations (e.g., Triumeq) influences market share.
Patent & Exclusivity Rights	Critical	Patents extend into the late 2020s/early 2030s, safeguarding market exclusivity initially, but potential patent cliffs pose future risks.

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Market Size and Segmentation

Global HIV Treatment Market (2022-2027)

Segment	2022 Market Size (USD bn)	Projected CAGR (2022-2027)	Notes
First-line Therapy	10.2	7.5%	Dominates market, driven by integrase-based regimens.
Second/Resistant Cases	3.7	9.2%	Growing segment, where Isentress HD targets heavily resistant cases.
Pediatric & Special Populations	1.5	5.8%	Niche but stable segment requiring tailored approaches.

Patient Demographics

• Adults (≥18 years): 86% of the total HIV population.
• Resistant Cases: Approximately 20%-25% of treated patients exhibit resistance, increasing demand for alternative high-dose therapies.

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Financial Trajectory and Revenue Forecasts

Revenue Drivers

Factor	Impact on Revenue	Details
Market Penetration	Moderate to High	Driven by clinical adoption in resistant and complex cases. Adoption in first-line therapy remains limited due to competition.
Pricing Strategy	Premium Pricing	Therapeutic benefits justify higher prices; however, payer negotiations influence net revenue.
Patent Life & Exclusivity	Critical	Patent expiry around 2027-2028 may lead to generic entry, impacting revenues.
Pipeline & Line Extensions	Growth Potential	Ongoing studies exploring combo formulations or alternative dosing may extend product life cycle.

Revenue Projections (2023-2027)

Year	Estimated Global Sales (USD millions)	Growth Rate	Notes
2023	120	—	Launch year with initial uptake in resistant cases.
2024	180	50%	Increased adoption and payer coverage.
2025	240	33%	Market expansion, especially in Europe and emerging markets.
2026	290	21%	Maturation phase, modest growth.
2027	320	10%	Sales plateau approaching patent expiration.

Assumptions: Growth driven by increased recognition as a viable option in resistant HIV; pending FDA approvals for line extensions could boost revenues.

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Competitive Landscape Analysis

Competitors	Products	Market Share (2022)	Strengths	Weaknesses
Gilead Sciences	Bictegravir-based FDCs (e.g., Biktarvy)	~45%	Established efficacy, convenience, broad label	Resistance concerns in certain subpopulations.
ViiV Healthcare	Dolutegravir-based combos (e.g., Tivicay)	~35%	Proven durability, global reach	Resistance mutations, dosing frequency.
Other	Raltegravir (original formulation), Elvitegravir	~10%	Established safety	Evolving resistance profile, lower potency.
Isentress HD	Raltegravir high-dose	Emerging	Active in resistant cases, potential niche	Limited first-line positioning, competition from newer agents.

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Regulatory & Market Access Considerations

Aspect	Details	Implications
Patent Status	Patents expiring in late 2020s	Patent cliff risks from 2027 onward.
FDA & EMA Approvals	Approved in multiple regions	Facilitates global market access, but label restrictions vary.
Pricing & Reimbursement	Tiered across markets	Reimbursement challenges in lower-income markets; premium in high-income countries.
Line Extensions & Combination Formulations	Under clinical development	Potential to extend product lifecycle.

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Potential Risks and Strategic Opportunities

Risks	Mitigation Strategies	Opportunities
Patent expiry leading to generics	Innovate with combination therapies, line extensions	Develop fixed-dose combinations with other antiretrovirals
Market share erosion from competitors	Accelerate evidence generation for resistant populations	Expand into emerging markets; leverage cost-effective manufacturing
Resistance development	Monitor resistance patterns; update treatment guidelines	Position as a reserve or specialized agent

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Comparison with Competitive High-Dose Options

Parameter	Isentress HD	Competitors (e.g., Bictegravir)	Analysis
Dosage	600 mg BID	Once daily (e.g., Biktarvy)	BID requirement may limit convenience; niche utility.
Efficacy	Effective in resistant strains	Generally high efficacy	Niche positioning for resistant cases.
Resistance Profile	Robust	Similar	Critical in resistant HIV management.
Pricing	Premium	Varies	Price premium supported by clinical niche.

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Key Takeaways

• Strategic Positioning: Isentress HD primarily targets resistant HIV populations, offering a key differentiation from once-daily integrase inhibitors.

• Revenue Potential: Estimated USD 120-320 million annually (2023-2027), contingent on market penetration, patent life, and competitive dynamics.

• Market Opportunities: Expansion in emerging markets, combination formulations, and evidence in resistant cases can bolster revenues.

• Challenges: Competition from newer agents, patent expirations, and reimbursement hurdles necessitate ongoing innovation and strategic planning.

• Long-term Outlook: Post-patent, generic raltegravir could substantially erode revenues, compelling Merck to explore line extensions and strategic alliances.

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FAQs

1. How does Isentress HD differ from the standard formulation of Raltegravir?
Isentress HD offers a higher dose (600 mg BID) than the standard 400 mg BID formulation, targeting resistance management in complex HIV cases and providing options for patients with suboptimal viral suppression.

2. What are the primary markets for Isentress HD?
Main markets include North America, Europe, and select emerging markets in Asia and Latin America, especially where resistant HIV strains are prevalent.

3. When is patent expiry likely, and how will it impact the market?
Patents are expected to expire around late 2027 to early 2028, after which generic manufacturers may enter, pressuring prices and sales volumes.

4. How does Isentress HD compare with newer integrase inhibitors like Dolutegravir?
While Dolutegravir-based regimens offer once-daily dosing with broad efficacy, Isentress HD's niche lies in resistant cases requiring high-dose therapy, limiting direct competition but also market size.

5. What strategic options exist post-patent expiry?
Merck can develop novel combinations, improve formulations, or pursue new indications to sustain revenue streams beyond patent expiry.

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References

[1] UNAIDS. (2022). Global AIDS Update 2022.
[2] Merck & Co. Inc. (2022). Isentress HD product information.
[3] WHO. (2023). HIV/AIDS Treatment Guidelines.
[4] EvaluatePharma. (2022). HIV market forecasts.
[5] Gilead Sciences. (2022). Boctegravir market analysis.

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In summary, Isentress HD occupies a specialized niche in the evolving HIV therapeutics landscape. Strategic positioning, patent management, and pipeline development will determine its long-term financial trajectory amid fierce competition and a shifting treatment paradigm.