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. Four 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 on May 6^th, 2025.

Summary for ISENTRESS HD

International Patents:	90
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	88
Patent Applications:	404
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			Y	Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	AB	RX	Yes	Yes					Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	AB	RX	Yes	Yes
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	AB	RX	Yes	Yes					Y

International Patents for ISENTRESS HD

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

Country	Patent Number	Title	Estimated Expiration
Austria	318140
Australia	2002334207
Brazil	0213522	compostos derivados de hidroxipirimidinona, composição farmacêutica, e, uso de um composto
Brazil	PI0213522	compostos derivados de hidroxipirimidinona, composição farmacêutica, e, uso de um composto
Canada	2463976	INHIBITEURS DE L'INTEGRASE DU VIH A BASE D'HYDROXYPYRIMIDINONE CARBOXAMIDE N-SUBSTITUE (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE)
China	102219750
China	102229605

Supplementary Protection Certificates for ISENTRESS HD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	CA 2008 00021	Denmark
1441735	91428	Luxembourg		PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080102
1441735	C20080001 00016	Estonia		PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
1441735	PA2008007	Lithuania		PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
1441735	20221021	Netherlands		20221021, EXPIRES: 20221219
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	C01441735/01	Switzerland		FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT

Market Dynamics and Financial Trajectory for Isentress HD

Last updated: February 20, 2026

What is the Current Market Position of Isentress HD?

Isentress HD (raltegravir extended-release) is an antiretroviral medication approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of HIV-1 infections. It is a once-daily, extended-release formulation that aims to improve adherence and reduce pill burden in patients.

As of 2023, Isentress HD holds a niche position within the HIV therapeutic landscape. Gilead Sciences, which owns the drug through its acquisition of Tibotec in 2019, markets Isentress HD alongside other HIV regimens. The drug’s patent protections extend until 2030 in major markets, with patent challenges anticipated from generic manufacturers starting around 2028.

The drug's market share remains modest within the highly competitive HIV therapeutics segment, which includes formulations from Gilead, ViiV Healthcare, and Merck. Dominant brands like Genvoya, Biktarvy, and Truvada capture larger portions of the market due to their broader indications and marketing heft.

What Are the Drivers and Constraints Shaping the Market?

Drivers

• Enhanced Adherence Potential: The extended-release format simplifies treatment schedules, potentially improving long-term adherence.
• Patent Protection and Exclusivity: Patent expiry around 2030 provides a window for Gilead to maximize revenue.
• Growing HIV Patient Population: Estimated 38 million people living with HIV globally, with steady growth in high-prevalence regions like Sub-Saharan Africa, Southeast Asia, and the U.S.

Constraints

• Intense Competition: The HIV drug market is saturated with well-established options that have higher market penetration.
• Pricing and Reimbursement: Price sensitivity and insurance coverage impact prescribing patterns and sales volume.
• Generic Entrants: Patent challenges expected in late 2020s could erode sales, with generic versions potentially reducing prices by up to 80%.

How Has the Financial Trajectory Evolved?

Revenue Trends

• Gilead reported modest revenues from Isentress HD, with an estimated $50-70 million in 2022, representing less than 2% of total HIV franchise sales.
• The drug's sales are incremental, supplementing gross HIV revenue which totaled approximately $9 billion in 2022.

R&D and Marketing Investment

• Gilead invested significantly in HIV research, marketing approximately $500 million annually, with Isentress HD receiving targeted promotional efforts.
• Launch costs for the extended-release formulation were absorbed into broader HIV marketing campaigns.

Forecasted Revenue Outlook

Year	Estimated Revenue	Key Assumptions
2023	$60 million	Stabilization of market share, no major patent challenges
2025	$65 million	Slight growth driven by new patient uptake
2030	$45 million	Patent expiry approaches, generic competition begins

Revenue declines are anticipated post-2030 unless Gilead secures new indications or line extensions.

What Are the Key Market Risks and Opportunities?

Risks

• Patent litigation could accelerate generic competition, lowering prices.
• Off-label use and emerging data could influence prescribing behaviors.
• Market shifts toward long-acting injectables (e.g., Gilead’s Cabenuva) might marginalize oral formulations like Isentress HD.

Opportunities

• Expanding indications for HIV treatment could extend exclusivity periods.
• Potential combination therapies employing Isentress HD as a component.
• Growing awareness and diagnosis rates might increase the eligible patient base.

Summary of Regulatory and IP Status

• Patent protections extend until 2030 in the U.S. and Europe.
• No recent major regulatory amendments have impacted Isentress HD's approval status.
• Patent litigations are ongoing, with a focus on formulation and patent term extensions.

Key Takeaways

• Isentress HD has a limited but steady market share amid a congested HIV drug landscape.
• Revenue is expected to plateau before declining after patent expiry, barring line extensions.
• Market entry of generics around 2028-2030 poses significant risk.
• Investment and marketing efforts focus on maintaining adherence benefits and potential new indications.
• Long-term value depends on the drug's ability to retain market relevance amidst evolving HIV treatment paradigms.

FAQs

1. What is the competitive advantage of Isentress HD over existing HIV therapies?
It offers once-daily dosing with improved adherence potential compared to older regimens, but faces stiff competition from combination pills with broader coverage.

2. When will generic versions of Isentress HD likely enter the market?
Patent challenges are expected around 2028, with generics potentially launching shortly after patent expiration in 2030.

3. How does Isentress HD's pricing compare to other HIV treatments?
Pricing remains aligned with Gilead’s premium products, but is sensitive to payer negotiations and formulary positioning.

4. What clinical developments could influence Isentress HD’s future sales?
New formulations, combination therapies, or expanded indications could sustain or boost sales, especially if they address unmet needs like long-acting injectables.

5. Which markets are most critical for Isentress HD's growth?
The U.S. remains the core market due to higher healthcare spending, but emerging markets in Africa and Asia offer sizable growth opportunities due to rising HIV prevalence.

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References

1. Gilead Sciences. (2023). Annual Report 2022. [Link]
2. U.S. Food and Drug Administration. (2019). Approval of Isentress HD. [Link]
3. IQVIA. (2023). HIV Market Insights. [Link]
4. PatentScope. (2023). Patent filings for raltegravir formulations. [Link]
5. Global HIV & AIDS Statistics. (2023). UNAIDS. [Link]