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ISENTRESS Drug Patent Profile

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

Isentress is a drug marketed by Msd Sub Merck and is included in three NDAs. There are six patents protecting this drug.

This drug has one hundred and twenty-five patent family members in forty-five countries.

The generic ingredient in ISENTRESS 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

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 11, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ISENTRESS

International Patents:	125
US Patents:	4
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	88
Patent Applications:	4,456
Drug Prices:	Drug price information for ISENTRESS
What excipients (inactive ingredients) are in ISENTRESS?	ISENTRESS excipients list
DailyMed Link:	ISENTRESS at DailyMed

See drug prices for ISENTRESS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ISENTRESS

Constraining patent/regulatory exclusivity:

7,754,731*PED

NDA:

205786

Dosage:

POWDER;ORAL

Constraining patent/regulatory exclusivity:

7,754,731*PED

NDA:

203045

Dosage:

TABLET, CHEWABLE;ORAL

Constraining patent/regulatory exclusivity:

9,649,311*PED

NDA:

022145

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.

Recent Clinical Trials for ISENTRESS

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 clinical trials

Pharmacology for ISENTRESS

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

US Patents and Regulatory Information for ISENTRESS

ISENTRESS is protected by four US patents.

This potential generic entry date is based on patent 7,754,731.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013		RX	Yes	Yes	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011		RX	Yes	Yes	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011		RX	Yes	No	7,754,731*PED				Y
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	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007		RX	Yes	Yes	8,852,632		Y	Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	7,169,780*PED
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	9,649,311*PED				Y

Expired US Patents for ISENTRESS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007	7,435,734*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007	7,169,780*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011	7,217,713*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011	7,435,734*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013	7,169,780*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011	7,435,734*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011	7,169,780*PED

International Patents for ISENTRESS

When does loss-of-exclusivity occur for ISENTRESS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Spain	2370136
Lithuania	2493312
Denmark	2493312
Spain	2898348
European Patent Office	1904067	FORMULATION PHARMACEUTIQUE DE DERIVES DE CARBOXAMIDE , INHIBITEURS DE L'HIV INTEGRASE, COMPRENANT UNE COMPOSITION A LIBERATION CONTRÔLEE (PHARMACEUTICAL FORMULATION OF CARBOXAMIDE HIV INTEGRASE INHIBITORS CONTAINING A RELEASE RATE CONTROLLING COMPOSITION)
Canada	2777937	COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT UN INHIBITEUR D'INTEGRASE (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING AN INTEGRASE INHIBITOR)
Norway	338784

Supplementary Protection Certificates for ISENTRESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	30/2008	Austria		PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436 (MITTEILUNG) 20071220
1441735	PA2008007	Lithuania		PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
1441735	DO 67; 3-2008	Slovakia		PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
1441735	C 2008 008	Romania		PRODUCT NAME: N-(2-(4-(4-FLUOROBENZILCARBAMOIL)-5-HIDROXI-1-METIL-6-OXO-1,6-DIHIDROPIRIMIDIN-2-IL)PROPAN-2+IL)-5-METIL-1,3,4-OXADIAZOL-2-CARBOXAMIDA - RALTEGRAVIR SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA, INSPECIAL SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF NATIONAL AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF FIRST AUTHORISATION IN EEA: 20071220
1441735	20221021	Netherlands		20221021, EXPIRES: 20221219

ISENTRESS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isentress (Raltegravir)

Overview of Isentress

Isentress, known generically as raltegravir, is an antiretroviral drug used to treat HIV infection. It is manufactured by Merck and works by inhibiting the integrase enzyme, which is crucial for the HIV virus to replicate.

Market Position and Sales Performance

Historical Sales

Isentress has been a significant contributor to Merck's revenue. In 2022, the drug generated $633 million in sales, although this figure has been declining due to increasing competition in the HIV treatment market[3].

Patent Expiry and Generic Competition

A critical factor affecting Isentress's market dynamics is the expiry of its patents. Some patents for Isentress have already expired, and additional patents are set to expire in the near future, starting in October 2023. This has led to tentative approvals for generic versions of raltegravir, such as the one granted to Hetero Labs[3].

Impact of Generic Competition

The entry of generic versions is expected to significantly impact Isentress's sales. Generic drugs typically offer lower prices, which can attract price-sensitive consumers and reduce the market share of the branded drug. This trend is likely to continue as more generics enter the market.

Distribution Channels

Pharmacy Settings

Isentress is distributed through various pharmacy settings, including chain drug stores, independent drug stores, mass merchandisers, and mail order/specialty pharmacies. According to data from 2013 to 2016, approximately 55% of Isentress bottles were sold to U.S. outpatient retail pharmacies, while 21% were sold to mail order/specialty pharmacy settings, and 24% to non-retail settings[4].

Financial Performance

Revenue Trends

The revenue from Isentress has been declining in recent years due to the aforementioned competition and patent expiry issues. Despite this, the drug remains a notable part of Merck's portfolio, although its contribution is diminishing.

Merck's Financial Results

Merck's overall financial performance provides context for Isentress's impact. In the first quarter of 2023, Merck reported total sales of $14.487 billion, with a GAAP net income of $2.821 billion. However, the company's R&D expenses increased significantly, by 66%, compared to the first quarter of 2022, which could be partly attributed to efforts to develop new drugs to offset the loss of exclusivity for existing ones like Isentress[2].

Charges and Adjustments

Merck has also incurred various charges, including a $573 million charge in the first quarter of 2023 related to settlements with certain plaintiffs in the Zetia antitrust litigation. These charges can affect the net income and EPS, making it essential to consider both GAAP and non-GAAP figures when evaluating the financial health of the company and the performance of specific drugs like Isentress[2].

Market Dynamics and Competitive Landscape

HIV Drugs Market

The global HIV drugs market is growing, driven by the rise in demand for HIV treatments, increased initiatives for awareness and diagnosis, and a rise in HIV cases. The market is expected to grow from $32.8 billion in 2022 to $51.1 billion by 2032, with a CAGR of 4.5%[1].

Regional Performance

North America, where Merck is based, has been the dominant region for the HIV drugs market, including Isentress. However, the Asia-Pacific region is expected to witness the highest CAGR during the forecast period due to a large population base and increasing healthcare expenditure[1].

Competitive Analysis

The HIV drugs market is highly competitive, with several major players including AbbVie, Bristol-Myers Squibb, Gilead Sciences, Johnson & Johnson, and Merck. The demand for new HIV drug options is on the rise due to ongoing research and development, increased healthcare expenditure, and patient advocacy. Emerging markets are gaining importance as companies focus on unmet medical demands, especially in developing economies[1].

Future Outlook

Generic Competition and Exclusivity

The future outlook for Isentress is heavily influenced by the impending generic competition. As more generics enter the market, the sales of the branded drug are likely to decline further. However, Merck's diverse portfolio and ongoing R&D efforts aim to mitigate this impact by introducing new products to cater to growing population needs, especially in developing economies[1][3].

Market Expansion and New Products

Merck and other pharmaceutical companies are focusing on emerging markets and investing in research and development to introduce new products. This strategy is crucial for maintaining market share and driving growth despite the loss of exclusivity for drugs like Isentress[1].

Key Takeaways

• Declining Sales: Isentress sales have been declining due to patent expiry and increasing competition.
• Generic Competition: The entry of generic versions of raltegravir is expected to further reduce Isentress's market share.
• Financial Impact: Merck's financial performance is affected by charges and adjustments, including those related to patent litigation and R&D expenses.
• Market Growth: The global HIV drugs market is growing, with the Asia-Pacific region expected to witness the highest CAGR.
• Competitive Landscape: The market is highly competitive, with major players focusing on new product development and emerging markets.

FAQs

What is Isentress used for?

Isentress, or raltegravir, is an antiretroviral drug used to treat HIV infection by inhibiting the integrase enzyme.

How much did Isentress generate in sales in 2022?

Isentress generated $633 million in sales in 2022.

What is the impact of patent expiry on Isentress sales?

The expiry of Isentress's patents has led to the approval of generic versions, which is expected to significantly reduce the sales of the branded drug.

Which regions are dominant in the HIV drugs market?

North America currently dominates the HIV drugs market, but the Asia-Pacific region is expected to witness the highest CAGR during the forecast period.

How is Merck addressing the loss of exclusivity for Isentress?

Merck is focusing on emerging markets and investing in research and development to introduce new products to mitigate the impact of generic competition.

Sources

1. HIV Drugs Market Research, 2032 - Allied Market Research
2. Merck Announces First-Quarter 2023 Financial Results - Business Wire
3. The Biopharma Patent Cliff: 9 Drugs Losing Exclusivity by the End of 2023 - BioSpace
4. Isentress Pediatric Postmarketing Pharmacovigilance and Drug Utilization Data - FDA
5. Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results - Merck