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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 five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-nine patent family members in forty-six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Isentress Hd

Isentress Hd was eligible for patent challenges on October 12, 2011.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ISENTRESS HD

International Patents:	139
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	88
Patent Applications:	106
Drug Prices:	Drug price information 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 five 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		RX	Yes	Yes	8,771,733		Y	Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	10,772,888

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

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

ISENTRESS HD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ISENTRESS HD (Raltegravir)

Introduction to ISENTRESS HD

ISENTRESS HD, a formulation of the integrase inhibitor raltegravir, was approved by the U.S. Food and Drug Administration (FDA) in 2017. This approval marked a significant milestone in the treatment of HIV-1 infection, offering a once-daily dosing option for patients[1].

Clinical Significance and Patient Impact

ISENTRESS HD is administered as two 600 mg film-coated tablets, taken once daily with or without food, in combination with other antiretroviral agents. This once-daily regimen is particularly beneficial for patients, as it simplifies their treatment schedule and can improve adherence.

Patient Preferences and Lifestyle

For people living with HIV, having a variety of effective therapies is crucial as it allows for treatments to be tailored to individual needs and lifestyles. As Carl Schmid, deputy executive director of the AIDS Institute, noted, "Having a wide range of effective therapies is important because it provides options to fit patients’ individual needs and lifestyles."[1]

Clinical Efficacy and Safety

The ONCEMRK study, a Phase 3 multicenter, double-blind trial, demonstrated the efficacy and safety of ISENTRESS HD. The study showed low rates of discontinuation due to adverse events and minimal drug-related clinical adverse reactions of moderate to severe intensity[1].

Market Trends in HIV-1 Treatment

Shift from Multiple Tablet Regimens (MTRs) to Single Tablet Regimens (STRs)

The HIV-1 treatment market has seen a significant shift from MTRs to STRs. Patients and physicians prefer STRs due to their convenience and improved patient compliance. The market for MTRs has been declining, while STRs have seen substantial growth. For instance, the US market for STRs increased from $10.3 billion in 2018 to $13.6 billion in 2020[4].

Competition and Market Share

ISENTRESS HD competes in a market dominated by other STRs, particularly those from Gilead Sciences, such as Biktarvy. Biktarvy, approved in 2018, has rapidly captured market share and is expected to become the market leader by 2024, with projected sales of $10.673 billion[4].

Financial Performance of ISENTRESS HD

Pricing Strategy

Merck announced that the price of ISENTRESS HD would be the same as the original ISENTRESS formulation, which is administered twice daily. This pricing strategy aims to maintain market competitiveness without adding additional financial burden to patients[1].

Revenue Impact

While specific revenue figures for ISENTRESS HD are not separately reported, the overall performance of Merck's HIV portfolio can be inferred from the company's financial reports. Merck's pharmaceutical sales have shown steady growth, although the impact of ISENTRESS HD on these figures is part of a broader HIV treatment market dynamic[3][5].

Patent Expiry and Future Outlook

ISENTRESS is set to lose patent protection in the US in 2024, which could significantly impact its market share and revenue. The loss of patent protection will allow for the entry of generic versions, potentially reducing the market share of the branded product[4].

Financial Trajectory of Merck

Quarterly and Annual Sales

Merck's overall financial performance has been strong, with total worldwide sales increasing by 4% in the third quarter of 2024 compared to the same period in 2023. However, the specific contribution of ISENTRESS HD to these figures is not detailed in the financial reports[5].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on Merck's financials, with reduced access to healthcare providers affecting vaccine sales but also leading to lower promotional and selling costs. This dynamic did not specifically target ISENTRESS HD but affected the broader pharmaceutical market[3].

Key Takeaways

• Once-Daily Dosing: ISENTRESS HD offers a convenient once-daily dosing option, improving patient adherence and quality of life.
• Market Trends: The HIV-1 treatment market is shifting towards STRs, with ISENTRESS HD competing against dominant players like Biktarvy.
• Financial Performance: While ISENTRESS HD's pricing is competitive, its revenue impact is part of Merck's broader pharmaceutical sales.
• Patent Expiry: The impending patent expiry of ISENTRESS in 2024 will likely impact its market share and revenue.
• Market Competition: The rise of Biktarvy and other STRs poses significant competition to ISENTRESS HD in the HIV-1 treatment market.

FAQs

What is ISENTRESS HD, and how is it administered?

ISENTRESS HD is a once-daily formulation of the integrase inhibitor raltegravir, administered as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents.

How does ISENTRESS HD compare to other HIV-1 treatments?

ISENTRESS HD competes in a market dominated by single tablet regimens (STRs) like Biktarvy. It offers a convenient once-daily dosing option but faces competition from more recently approved and highly effective STRs.

What is the impact of patent expiry on ISENTRESS HD?

The patent expiry of ISENTRESS in 2024 is expected to significantly impact its market share and revenue, as generic versions will become available.

How has the COVID-19 pandemic affected Merck's financials?

The COVID-19 pandemic had a mixed impact on Merck's financials, with reduced access to healthcare providers affecting vaccine sales but also leading to lower promotional and selling costs.

What are the most common adverse reactions associated with ISENTRESS HD?

The most commonly reported adverse reactions include abdominal pain, diarrhea, vomiting, and decreased appetite, with low rates of discontinuation due to adverse events[1].

Sources

1. Merck Receives FDA Approval of ISENTRESS® HD (raltegravir), a New Once-Daily Option, in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Appropriate Patients. Merck News.
2. Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results. Merck News.
3. Merck Announces Fourth-Quarter and Full-Year 2020 Financial Results. Merck News.
4. Changing Dynamics of HIV-1 Treatment Market. DelveInsight.
5. Merck Announces Third-Quarter 2024 Financial Results. Merck News.