LAMIVUDINE; RALTEGRAVIR POTASSIUM - Generic Drug Details

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

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

Constraining patent/regulatory exclusivity:

7,754,731*PED

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	7,754,731*PED				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	7,169,780*PED
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,820,660
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,435,734*PED
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,217,713*PED

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
World Intellectual Property Organization (WIPO)	2006060712
Spain	2370136
Slovenia	1819700
Morocco	29120	SEL DE POTASSIUM D'UN INHIBITEUR DE L'INTEGRASE DU VIH

Supplementary Protection Certificates for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0382526	96C0035	Belgium		PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228

Market Dynamics and Financial Trajectory for Lamivudine and Raltegravir Potassium

Last updated: July 29, 2025

Introduction

The global pharmaceutical landscape for antiretroviral therapies (ART) has experienced significant evolution, driven by emergent viral strains, drug resistance, and innovations in drug delivery systems. Lamivudine and raltegravir potassium stand as pivotal agents within this domain, offering critical options for managing HIV/AIDS. This analysis delineates key market dynamics, financial trajectories, and factors shaping the future prospects of these drugs by examining their clinical utility, patent landscape, competitive environment, and regulatory factors.

Clinical Significance and Market Penetration

Lamivudine (3TC), a nucleoside reverse transcriptase inhibitor (NRTI), has been foundational in antiretroviral regimens since its approval in the late 1990s. Its versatility spans monotherapy and combination therapies, often paired with agents like zidovudine or tenofovir. Its affordability and established safety profile underpin widespread adoption, particularly in low- and middle-income countries (LMICs). According to UNAIDS, lamivudine remains a staple in the global HIV treatment arsenal, especially where generic formulations dominate due to lower costs.

Raltegravir (marketed as Raltegravir potassium), introduced in 2007 by Merck (MSD), marked the advent of integrase strand transfer inhibitors (INSTIs), representing a significant technological advancement. Raltegravir’s place in therapy is primarily as part of salvage regimens in treatment-experienced patients and as a first-line option in certain cases. Its high efficacy, favorable side-effect profile, and rapid viral suppression capabilities have led to robust prescription patterns within high-income regions. The drug’s market penetration is further supported by its once- or twice-daily dosing and favorable interactions.

Patent Landscape and Generic Competition

The financial trajectory of lamivudine has been heavily influenced by patent expirations and rising generic competition. The original patents, held by GlaxoSmithKline (GSK), expired around the late 2000s to early 2010s in many jurisdictions, catalyzing a surge in generic manufacturing. This led to sharply reduced prices—sometimes as low as $60 per year per patient—prompting extensive use in resource-limited settings and contributing to a rapid volume-driven revenue model.

In contrast, raltegravir’s patent life is comparatively limited, with the patent expiring or nearing expiry in major markets like the U.S. and Europe by 2024–2025. This expiration opens the potential for substantial generic entry, although alternative branded INSTIs such as dolutegravir have gained market share, partly offsetting potential revenue declines for raltegravir. The competitive landscape is further characterized by newly approved INSTIs like bictegravir and cabotegravir, intensifying market competition and challenging raltegravir’s financial trajectory.

Market Drivers and Constraints

Drivers:

• Global HIV/AIDS burden: With over 38 million people living with HIV globally[1], the sustained demand for effective ART drives the market for drugs like lamivudine and raltegravir.
• Cost-effectiveness and generics: The proliferation of affordable generics for lamivudine fuels demand, especially in LMICs.
• Regulatory approvals: Expanding indications, including once-daily fixed-dose combinations, enhance market access.
• Clinical efficacy and safety profiles: High tolerability and efficacy bolster adherence, fostering repeat prescription cycles.

Constraints:

• Patent expirations: Future expirations threaten revenue streams for both drugs, especially raltegravir.
• Market saturation: Increasing use of newer INSTIs with superior resistance profiles affect raltegravir’s market share.
• Pricing pressures: Transparent pricing in global alliances and government tenders constrains profit margins.
• Development of resistance: Emergence of drug-resistant HIV strains necessitates combinations with newer agents, potentially reducing demand for older drugs.

Financial Trajectory and Revenue Outlook

Lamivudine:
Once a blockbuster, lamivudine’s revenues peaked during the early 2000s but have since diminished due to patent expirations and commoditization. According to market research, the global lamivudine market revenue has declined by approximately 40% over the past decade. Nevertheless, the drug remains essential in fixed-dose combinations, ensuring continued volume sales. The global lamivudine market is estimated to be valued at around $1.2 billion in 2022, predominantly driven by generic sales in LMICs. This makes it a stable revenue stem for generic manufacturers but a declining figure for branded originators.

Raltegravir:
Market forecasts project that raltegravir’s revenues will peak around 2023–2024, with estimates valuing its global sales at approximately $900 million in 2022. However, as patents expire and new agents gain favor, a decline of up to 25% per annum post-expiry is anticipated. Investment in lifecycle management strategies, including combination formulations and new indications, will influence these trajectories. For instance, the approval of long-acting formulations (injectable cabotegravir/rilpivirine) indicates a potential shift in the market dynamics, although raltegravir’s role in this space may diminish.

Emerging Market Opportunities and Challenges

Emerging markets present lucrative growth opportunities via expanding access to ART and increasing healthcare infrastructure. Countries like India and Nigeria are poised for increased lamivudine adoption due to cost advantages. Conversely, raltegravir faces challenges in penetration due to higher prices and the availability of more advanced agents. Regional regulatory barriers and supply chain issues can also impede growth, although strategic partnerships and licensing agreements could mitigate these limitations.

Impact of Innovation and Future Developments

The pipeline of second- and third-generation antiretroviral agents is robust, introducing drugs with improved bioavailability, resistance profiles, and dosing convenience. Notably:

• Bictegravir (BIC): An INSTI with higher barrier to resistance, gaining significant market share.
• Dolutegravir (DTG): Now the preferred INSTI in many guidelines, with patent protection extending until at least 2030.
• Long-acting formulations: Injectable therapies like cabotegravir and rilpivirine are poised to redefine treatment paradigms, potentially reducing demand for older agents like raltegravir.

This evolution pressures raltegravir’s revenues downward and necessitates strategic repositioning for sustaining profitability.

Regulatory and Patent Expiry Impact

The imminent patent expiries for raltegravir and the widespread generic availability of lamivudine are pivotal influences on their respective financial trajectories. Patent transitions typically result in rapid pricing erosion; for example, after patent expiry, lamivudine’s price plummeted, with generic manufacturers capturing substantial market share. For raltegravir, patent revocation coupled with market entry of generics will similarly impact revenue, unless proprietary formulations or combination therapies sustain competitive differentiation.

Conclusion and Strategic Outlook

While lamivudine continues to generate stable, albeit declining, revenue primarily through generic sales and combination therapies, raltegravir’s prospects hinge on patent expiry timelines and the competitive landscape of newer INSTIs. Pharmaceutical companies must adapt by focusing on lifecycle management, exploring formulations (e.g., fixed-dose combinations, long-acting injectables), and expanding into emerging markets.

Potential strategies include:

• Developing new combination therapies incorporating lamivudine with novel agents.
• Investing in long-acting injectable formulations to capture evolving treatment preferences.
• Fostering partnerships aimed at generic licensing to maximize sales post-patent expiry.
• Monitoring regulatory changes and patent statuses to optimize timing for market entry or portfolio adjustments.

Key Takeaways

• Market stability for lamivudine is primarily due to its affordability and extensive use in fixed-dose combinations, especially in LMICs, despite declining revenues.
• Raltegravir’s revenue potential is under threat from patent expiries and the rise of more advanced INSTIs like dolutegravir, necessitating strategic innovation.
• Patent expirations significantly influence pricing and market share, with generics dominating once patents lapse.
• Emerging long-acting formulations and combination therapies represent critical growth vectors for sustained profitability.
• The dynamic landscape mandates proactive portfolio management, including pipeline development and strategic licensing, to optimize financial returns.

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FAQs

1. What factors primarily influence the market share of lamivudine and raltegravir?

Patent status, emergence of generics, development of resistance, comparator drug efficacy, and evolving treatment guidelines.

2. How do patent expirations impact the revenues of these drugs?

Expirations lead to generic competition, significantly reducing prices and market share, thereby causing revenue declines unless protected by new formulations or combination therapies.

3. What role do emerging markets play in the future of lamivudine and raltegravir?

Emerging markets remain crucial for volume sales of lamivudine due to affordability, while raltegravir faces challenges due to higher costs but could benefit from strategic licensing and access programs.

4. Are there promising new drugs that could replace raltegravir in the future?

Yes, drugs like dolutegravir and bictegravir offer higher barriers to resistance and have gained wider adoption, posing competitive threats to raltegravir.

5. What strategic moves should pharmaceutical companies consider regarding these drugs?

Invest in lifecycle management through new formulations, explore combination therapies, seek licensing arrangements for generics, and monitor patent timelines to optimize revenue opportunities.

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References

1. UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
2. MarketResearch.com. Global antiretroviral drugs market analysis, 2022–2030.
3. U.S. Patent and Trademark Office. Patent expiration timelines for raltegravir.
4. World Health Organization. HIV treatment guidelines and drug recommendations.