Raltegravir potassium - Generic Drug Details

What are the generic sources for raltegravir potassium and what is the scope of freedom to operate?

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. Five 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:	5
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
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011		RX	Yes	Yes	7,754,731*PED				Y
Hetero Labs Ltd Iii	RALTEGRAVIR POTASSIUM	raltegravir potassium	TABLET;ORAL	203540-001	Dec 19, 2024		DISCN	No	No
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	7,754,731*PED				Y
Lupin Ltd	RALTEGRAVIR POTASSIUM	raltegravir potassium	TABLET;ORAL	217990-001	May 6, 2025	AB	RX	No	No

Expired US Patents for raltegravir potassium

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	7,435,734*PED
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	7,169,780*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007	7,217,713*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011	7,217,713*PED
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011	7,435,734*PED

International Patents for raltegravir potassium

Country	Patent Number	Title	Estimated Expiration
Australia	2010313571	Solid pharmaceutical compositions containing an integrase inhibitor
Brazil	PI0518781	formulaÇço farmacÊutica, processo para preparar uma formulaÇço farmacÊutica, e, uso de um composto
Russian Federation	2602865	ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ИНГИБИТОР ИНТЕГРАЗЫ (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING INTEGRASE INHIBITOR)
Lithuania	2493312
Israel	219369	תכשירים רוקחיים מוצקים המכילים מעכב אינטגראז (Solid pharmaceutical compositions containing an integrase inhibitor)

Supplementary Protection Certificates for raltegravir potassium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
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	91428	Luxembourg		PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080102
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	SZ 30/2008	Austria		PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ

Market Dynamics and Financial Trajectory for Raltegravir Potassium

Last updated: July 28, 2025

Introduction

Raltegravir potassium, known commercially as Isentress, is an HIV-1 integrase strand transfer inhibitor (INSTI). Approved globally since 2007, it revolutionized antiretroviral therapy (ART) by introducing a novel mechanism for inhibiting HIV replication. Its significance in HIV management accentuates its market relevance, shaping both market dynamics and financial trajectories. This analysis examines the evolving landscape, competition, regulatory influences, and future growth potential of raltegravir potassium in the pharmaceutical sphere.

Market Overview

Historical Market Performance

Raltegravir emerged amid rising global HIV prevalence, especially in regions with limited access to advanced ART options. Initially marketed by Merck & Co., it quickly gained traction owing to its efficacy, tolerability, and the advantages of oral dosing. By 2014, total sales globally peaked at approximately USD 1.3 billion, reflecting high adoption rates in developed nations and gradual penetration into emerging markets (IQVIA data).

Current Market Landscape

The present-day market for raltegravir reflects intensified competition from newer INSTIs like dolutegravir and bictegravir. These agents offer improved resistance profiles, tolerability, and simplified dosing regimens, diluting raltegravir's market share. Nonetheless, raltegravir retains importance for specific patient populations, including treatment-experienced individuals with resistant strains.

Market Segments and Geography

North America and Europe remain dominant, accounting for over 70% of global sales due to healthcare infrastructure and HIV prevalence. Emerging markets in Africa, Asia, and Latin America represent growth opportunities, driven by expanding ART programs and WHO guidelines advocating early initiation of HIV treatment.

Market Drivers

1. Advancements in HIV Treatment Paradigms
   The shift towards integrase inhibitors as first-line therapy has bolstered raltegravir's adoption historically. Its potent antiviral activity and favorable safety profile supported widespread use.

2. Regulatory Approvals and Label Expansion
   Ongoing approvals for pediatric use and combination formulations expand its applications, stimulating sales.

3. Resistant HIV Strains and Treatment-Experienced Patients
   Resistance to other antiretrovirals, especially NNRTIs and certain protease inhibitors, necessitates raltegravir use in salvage therapy, sustaining demand.

4. Growing HIV Prevalence
   Estimated 38 million globally living with HIV, with millions on ART—creating a sustained need for effective antiretrovirals.

Key Market Challenges

1. Emergence of Superior Alternatives
   The advent of dolutegravir, with once-daily dosing and a high barrier to resistance, has significantly challenged raltegravir’s market dominance.

2. Patent Expirations and Generic Entry
   Merck’s patent expiry in 2019 in certain jurisdictions permits generics, exerting downward pressure on prices and profit margins.

3. Pricing Pressures
   Cost-containment policies and competition have led to declining prices, especially in low- and middle-income countries.

4. Regulatory and Reimbursement Barriers
   Uneven reimbursement policies influence accessibility and sales volume.

Financial Trajectory

Sales Trends

After peaking in the early 2010s, sales of raltegravir have experienced a decline, averaging approximately 12% annually post-2016. The generic entry in key markets notably depressed prices and volume. Nonetheless, in niche segments such as treatment-experienced populations, sales remained resilient, with incremental growth driven by label expansions and combination therapies.

Profitability Outlook

Margins have compressed due to pricing pressures and increased competition. R&D investments for newer formulations or combination therapies involving raltegravir are ongoing to prolong its lifecycle. Financial forecasts suggest modest continued revenue, stabilizing at around USD 600–800 million annually over the next five years, with potential upside from expanding indications or regional market penetration.

Investment and Pipeline Implications

Pharma companies invested in developing long-acting formulations, such as injectables, could leverage raltegravir’s core molecule for future revenue streams. The pipeline includes formulations aimed at improving adherence and reducing dosing frequency, which could rejuvenate its market viability.

Regulatory and Patent Landscape

Patent protections in North America and Europe predominantly expired by 2019, facilitating generic competition. Regulatory agencies continue to approve new combination therapies integrating raltegravir, maintaining its presence in treatment guidelines. Regulatory hurdles remain minimal in well-established markets but significant in developing regions, where approval procedures are often protracted.

Future Outlook and Market Opportunities

Expanding Indications and Formulations

Long-acting injectable formulations are poised to transform HIV management. Trials involving injectable raltegravir are promising, potentially opening a new horizon for market growth. If successful, these could command premium pricing and drive revenues.

Emerging Markets

The expanded access initiatives, tiered pricing models, and partnerships with governments position raltegravir favorably for growth in resource-limited settings. The World Health Organization’s advocacy for accessible ART further supports this trajectory.

Competitive Landscape

While newer INSTIs have shared the banner, raltegravir's established safety profile and existing manufacturing infrastructure offer certain advantages. Its role in salvage therapy remains pertinent, offering niche but sustained demand.

Challenges and Risks

Patent expiration risks commoditization; the decline of brand premium; the rapid commercialization of next-generation drugs; and potential regulatory barriers in new markets pose ongoing challenges.

Conclusion

Raltegravir potassium's market dynamics are characterized by initial rapid growth, subsequent competitive pressures, and strategic repositioning towards niche and salvage therapies. Its financial trajectory reflects a maturation phase with declining sales, yet opportunities persist through formulation innovation and expanding geographic access. Stakeholders must monitor the evolving landscape closely, emphasizing differentiated offerings and strategic collaborations to sustain value.

---

Key Takeaways

• Market evolution has transitioned raltegravir from a first-line agent to a niche player, primarily serving treatment-experienced or resistant HIV cases.
• Patent expiries and generics have significantly pressured pricing, necessitating innovation in formulations and indications.
• Long-acting injectable formulations represent a critical growth avenue, potentially revitalizing the drug’s market presence.
• Emerging markets offer substantial potential, supported by global health initiatives and increasing HIV prevalence.
• Competition from newer INSTIs underscores the importance of strategic differentiation and pipeline development for sustained profitability.

---

FAQs

1. How has patent expiration affected raltegravir’s market position?
Patent expiry in key regions opened the market to generics, leading to increased competition, lowered prices, and a decline in sales for branded formulations.

2. What are the prospects of long-acting raltegravir formulations?
Clinical trials indicate promising results, and if approved, long-acting injectables could significantly boost demand by improving adherence and patient convenience.

3. In what patient populations does raltegravir remain the preferred agent?
It remains vital for treatment-experienced patients with resistant strains and in salvage therapy where other drugs fail or are contraindicated.

4. How do emerging markets influence raltegravir’s future?
Expanding HIV prevalence, WHO guidelines, and cost-effective generic options bolster its use, especially in resource-limited settings, offering growth potential.

5. What strategic moves should pharmaceutical companies prioritize for raltegravir?
Investing in novel formulations, expanding indications, forging partnerships in emerging markets, and accelerating clinical trials for alternatives can sustain its relevance.

---

Sources
[1] IQVIA Institute. "The Global Use of Medicine in 2020," 2021.
[2] Merck Annual Reports, 2010–2022.
[3] World Health Organization. "Global AIDS Update 2022."
[4] U.S. Food and Drug Administration. Drug Approvals.
[5] MarketWatch. "HIV Drugs Market Size, Trends, and Forecasts," 2022.