Lamivudine; raltegravir potassium - Generic Drug Details

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

Lamivudine; raltegravir potassium is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Lamivudine; raltegravir potassium has forty-six patent family members in thirty-five countries.

Summary for lamivudine; raltegravir potassium

International Patents:	46
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lamivudine; raltegravir potassium
DailyMed Link:	lamivudine; raltegravir potassium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lamivudine; raltegravir potassium

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 lamivudine; raltegravir potassium

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

Sponsor	Phase
St. James's Hospital, Ireland	Phase 4

See all lamivudine; raltegravir potassium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for lamivudine; raltegravir potassium

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

US Patents and Regulatory Information for lamivudine; raltegravir potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No					Y

Expired US Patents for lamivudine; raltegravir potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015

EU/EMA Drug Approvals for lamivudine; raltegravir potassium

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp Dohme Limited	Dutrebis	lamivudine, raltegravir potassium	EMEA/H/C/003823Dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).	Withdrawn	no	no	no	2015-03-26

International Patents for lamivudine; raltegravir potassium

Country	Patent Number	Title	Estimated Expiration
Serbia	52197	KALIJUMOVA SO INHIBITORA HIV INTEGRAZE (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
European Patent Office	1819700	SEL DE POTASSIUM D'UN INHIBITEUR DE L'INTEGRASE DU VIH (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
Taiwan	200631944	Potassium salt of an HIV integrase inhibitor
Eurasian Patent Organization	012418	КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITORS)
Norway	338784

Supplementary Protection Certificates for lamivudine; raltegravir potassium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0382526	96C0035	Belgium		PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
3494972	LUC00346	Luxembourg		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
3494972	24C1024	France		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, INCLUANT LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
3494972	2024C/522	Belgium		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217

Lamivudine; raltegravir potassium Market Analysis and Financial Projection

Last updated: February 15, 2026

What are the market dynamics for lamivudine and raltegravir potassium?

Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) primarily used in treating HIV and hepatitis B virus (HBV) infections. It is widely available as a generic medication, with extensive global manufacturing and distribution channels. It faces competition from other NRTIs like tenofovir and emtricitabine, with pricing pressures driven by generic manufacturing. The patent for the original formulation expired in many jurisdictions by the early 2010s, boosting generic market penetration.

Raltegravir potassium is an integrase strand transfer inhibitor (INSTI) developed by Merck, used in combination therapies for HIV. It was the first approved integrase inhibitor in 2007. Since then, it maintained a niche position in ART (antiretroviral therapy), but newer drugs such as dolutegravir and bictegravir have taken market share, impacting raltegravir’s sales.

Global HIV treatment markets are expanding, especially in low- and middle-income countries, driven by increased access to generics and international funding (e.g., PEPFAR). However, drug competition, patent expirations, and evolving treatment guidelines influence market shares.

How is the revenue outlook shaping up for lamivudine?

The global HIV market was valued at approximately $28 billion in 2022, with nucleoside reverse transcriptase inhibitors comprising robust segments. Lamivudine’s share is declining due to patent expirations and the rise of fixed-dose combinations (FDCs) incorporating other agents such as tenofovir and emtricitabine.

Pricing pressures limit high-margin sales, especially in emerging markets. In 2022, generic lamivudine formulations were priced as low as $0.05 per tablet in certain regions. Meanwhile, branded versions still generate hundreds of millions yearly due to established use and patent protections in some territories.

In developed markets, lamivudine largely serves as a component of combination therapies, not sold as monotherapy. The shift towards integrase inhibitors as first-line therapy reduces its standalone revenue potential. However, generics keep it a staple in HIV management globally.

What is raltegravir potassium's financial trajectory?

Raltegravir had peak sales of nearly $1.8 billion in 2014. Since the approval of next-generation INSTIs like dolutegravir (marketed by ViiV Healthcare and others), raltegravir's revenues contracted. By 2022, its global sales dropped below $400 million, reflecting decreased prescribing and the shift towards newer agents with better tolerability and dosing convenience.

The drug remains prescribed for salvage therapy and when newer drugs are contraindicated, but its market share diminishes as physicians prefer more tolerable regimens with higher barriers to resistance. Merck continues to market raltegravir, but its market position is now primarily driven by existing patents expiring in key markets and patent protections for older formulations ending in the early 2020s.

How do patent cycles and regulatory factors influence outlook?

Patent expirations for lamivudine in many regions occurred between 2010 and 2015, facilitating widespread generic manufacturing. In contrast, raltegravir's patent protection in the US expired in 2020, but its market share decline had already begun due to newer drugs.

Regulatory pathways such as expedited approval, biosimilars, and variants influence market accessibility. Emerging markets often rely on generic formulations, leading to price erosion. Developed markets see slow adoption of generics, maintaining higher prices but limited growth.

Market entrants and competition

• Lamivudine: Extensive generics, low-cost manufacturing, but stiff competition from tenofovir-based FDCs.
• Raltegravir: Competition from dolutegravir and bictegravir, which offer improved dosing and safety profiles, limiting market share for raltegravir.

What potential does the future hold?

Lamivudine: Expected to retain a significant presence in generic markets, particularly in low-income countries, but incremental growth is unlikely due to competition from newer combinations.

Raltegravir: Anticipated to decline further in sales, with continued use in specific niches like salvage therapy. Market share will be influenced by newer drugs' patent status and regulatory acceptance.

Key financial influences

Factor	Effect on Market	Timeline
Patent expiration	Price reduction, generic entry	Lamivudine (2010–2015), Raltegravir (2020)
Development of new therapies	Market share erosion	2015–present
Global HIV treatment expansion	Sustained demand in low-income areas	Ongoing
Regulatory approvals	Faster entry of generics, biosimilars	Ongoing

Key Takeaways

• Lamivudine maintains a large volume driven by generics in low-income markets but faces declining revenue in developed markets due to newer combination therapies.
• Raltegravir's market share is shrinking amid competition from drugs with improved profiles, with revenues below peak levels since 2014.
• Patent expiries for both drugs have significantly shaped market landscapes, enabling generics and reducing pricing.
• The future of these drugs hinges on patent protection status, competition from newer agents, and global treatment access initiatives.

FAQs

Q1: How have patent expirations impacted the lamivudine market?
Patent expirations led to a surge in generic manufacture, significantly reducing prices and maintaining widespread availability but limiting profit margins for originators.

Q2: Are there new formulations of raltegravir in development?
No major new formulations of raltegravir are currently under development. Market focus shifts to newer INSTIs like dolutegravir.

Q3: What regions are primary markets for lamivudine?
Low- to middle-income countries, especially in Africa and Asia, are the largest markets, driven by affordability and international aid programs.

Q4: How do newer HIV drugs influence the market for older agents?
They diminish sales of older drugs like raltegravir by offering better safety, tolerability, and simplified dosing, leading to preferential prescribing.

Q5: Will lamivudine's market share recover?
Unlikely; largely driven by existing generics and established use. Future growth depends on the expansion of HIV treatment programs rather than new product introductions.

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Citations:
[1] IQVIA. Global HIV Market Data, 2022.
[2] Merck filings and financial reports, 2022.
[3] WHO Global Health Observatory, 2022.