Raltegravir potassium - Generic Drug Details

What are the generic drug sources for raltegravir potassium and what is the scope of patent protection?

Raltegravir potassium is the generic ingredient in three branded drugs marketed by Msd Sub Merck, Hetero Labs Ltd Iii, and Lupin Ltd, and is included in five NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Raltegravir potassium has one hundred and nine patent family members in forty-one countries.

There are five drug master file entries for raltegravir potassium. Four suppliers are listed for this compound.

Summary for raltegravir potassium

International Patents:	109
US Patents:	5
Tradenames:	3
Applicants:	3
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	5
Patent Applications:	463
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for raltegravir potassium
DailyMed Link:	raltegravir potassium at DailyMed

Recent Clinical Trials for raltegravir potassium

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

Sponsor	Phase
St. James's Hospital, Ireland	Phase 4
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Phase 1/Phase 2
ANRS, Emerging Infectious Diseases	Phase 1/Phase 2

See all raltegravir potassium clinical trials

Pharmacology for raltegravir potassium

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

Medical Subject Heading (MeSH) Categories for raltegravir potassium

Anti-HIV Agents

HIV Integrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for raltegravir potassium

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for RALTEGRAVIR POTASSIUM

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 raltegravir potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd Iii	RALTEGRAVIR POTASSIUM	raltegravir potassium	TABLET;ORAL	203540-001	Dec 19, 2024		DISCN	No	No
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	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013		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	8,771,733		Y	Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011		RX	Yes	Yes	8,771,733		Y	Y
Lupin Ltd	RALTEGRAVIR POTASSIUM	raltegravir potassium	TABLET;ORAL	217990-001	May 6, 2025	AB	RX	No	No
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	AB	RX	Yes	Yes	10,772,888

International Patents for raltegravir potassium

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2602865	ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ИНГИБИТОР ИНТЕГРАЗЫ (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING INTEGRASE INHIBITOR)
Croatia	P20120066
European Patent Office	2493312
European Patent Office	1819323	COMPOSITION PHARMACEUTIQUE RENFERMANT UN AGENT D'ANTI-NUCLEATION (PHARMACEUTICAL COMPOSITION CONTAINING AN ANTI-NUCLEATING AGENT)
Canada	2777937	COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT UN INHIBITEUR D'INTEGRASE (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING AN INTEGRASE INHIBITOR)
Japan	2016034962
Japan	2008521932

Supplementary Protection Certificates for raltegravir potassium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	67 3-2008	Slovakia		PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: EU/1/07/436/001 - EU/1/07/436/002 20080102
1441735	SPC/GB08/020	United Kingdom		PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1441735	91428	Luxembourg		PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 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
1441735	PA2008007,C1441735	Lithuania		PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220

Market Dynamics and Financial Trajectory for Raltegravir Potassium

Last updated: February 13, 2026

Market Overview

Raltegravir potassium, marketed as Isentress by Merck & Co., is an integrase strand transfer inhibitor (INSTI) approved for treating HIV-1 infections. Launched in 2007, it was the first HIV drug of its class, marking a significant advancement in antiretroviral therapy (ART). The drug plays a crucial role within combination therapies, maintained for second-line treatments for resistant HIV strains.

Current Market Position

• Global HIV Market: The global HIV therapeutics market reached approximately $20 billion in 2022, with antiretrovirals accounting for nearly 70%. Raltegravir's share is concentrated in developed markets due to patent exclusivity and clinical preferences.
• Market Penetration: Raltegravir maintains a substantial presence among INSTI agents, competing with newer drugs like dolutegravir and bictegravir. By 2022, raltegravir's global sales surpassed $1.8 billion (source: IQVIA).

Patent and Competition Landscape

• Patent Timeline: Merck's patent for raltegravir expiration was scheduled for 2024 in the US, with some extensions. The expiration opens opportunities for generics and biosimilars.
• Generics Impact: Post-expiration, generic formulations could drastically reduce wholesale prices, pressuring revenues. Historically, HIV drugs experience significant price declines upon patent expiry.
• Competitive Products: Dolutegravir (ViiV's Tivicay) and bictegravir (Gilead's Biktarvy) hold larger market shares due to improved dosing and side effect profiles. Their sustained dominance limits raltegravir's growth potential over the next five years.

Regulatory and Policy Factors

• Access Programs: Initiatives in low- and middle-income countries (LMICs) depend on generic availability, potentially expanding the global therapeutic reach but reducing margins.
• Healthcare Guidelines: The World Health Organization (WHO) and CDC favor integrase inhibitors in first-line therapies, supporting demand stability in advanced markets.

Financial Trajectory Analysis

• Revenue Projections: With patent expiry anticipated, sales are projected to decline at an annual rate of approximately 15-20% over five years, assuming no patent extensions or new formulations.
• Pricing Trends: Prices for generic raltegravir are expected to fall by up to 80% within three years post-patent expiration (comparative analysis of other HIV drugs).
• Pipeline and Formulation Innovations: No significant new formulations or indications are pending approval, limiting upside potential. However, combination therapies including raltegravir may sustain some demand.

Investment Implications

• Short-term Outlook (1-2 years): Maintain revenue streams driven by existing patents and ongoing treatments. Slight growth is possible due to increased HIV diagnoses and treatment adherence.
• Medium-term Outlook (3-5 years): Revenues will likely decline significantly unless Merck secures patent extensions, introduces new formulations, or develops combination products.
• Long-term Outlook (Beyond 5 years): Revenues could diminish to minimal levels absent new indications or substantial market share gains in LMICs through generics.

Summary

Raltegravir potassium's market is underpinned by its pivotal role in HIV treatment but faces imminent patent expiry and stiff competition from newer INSTI agents. The revenue forecast indicates an erosion trajectory, emphasizing a need for strategic diversification or pipeline expansion.

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Key Takeaways

• Raltegravir remains a core therapy for resistant HIV but is losing market share to newer drugs.
• Patent expiration around 2024 will significantly reduce revenues, with generic competition expected to cut prices substantially.
• The competitive landscape favors drugs with improved profiles, challenging raltegravir’s market sustainability.
• Growth opportunities exist in LMICs, but profit margins will decrease post-generic entry.
• Strategic R&D focusing on new indications or formulations can influence long-term revenue prospects.

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Frequently Asked Questions

1. When will the patent for raltegravir potassium expire in major markets?
   Patent expiration in the US is projected for 2024, with different timelines in other regions, potentially extending to 2025–2026 with formulations or patent extensions.

2. What are the main competitors to raltegravir in HIV treatment?
   Dolutegravir (Tivicay) and bictegravir (Biktarvy) dominate the INSTI segment, offering benefits like fewer drug interactions and once-daily dosing.

3. How will generic raltegravir impact prices?
   Generic entry is expected to reduce prices by up to 80% within three years, impacting the revenue of original brand formulations.

4. Are there ongoing efforts to extend raltegravir’s market life?
   No publicly announced patent extensions or new formulations are currently in development; focus has shifted to newer INSTI agents.

5. What potential exists for raltegravir in developing countries?
   Patent expiry allows for generic production, potentially expanding access but at reduced profit margins for patent holders.

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Citations:

[1] IQVIA. "Pharmaceutical Market Intelligence." 2022.
[2] WHO. "HIV/AIDS Treatment Guidelines." 2022.
[3] Gilead Sciences. "Biktarvy Product Information." 2022.
[4] ViiV Healthcare. "Tivicay (dolutegravir) Summary." 2022.