lamivudine; raltegravir potassium - Profile

What are the generic 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lamivudine; raltegravir potassium

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.

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

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
South Africa	200704130	Protassium salt of an HIV integrase inhibitor
Eurasian Patent Organization	012418	КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITORS)
World Intellectual Property Organization (WIPO)	2006060730

Supplementary Protection Certificates for lamivudine; raltegravir potassium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN 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

Investment Scenario and Fundamentals Analysis for Lamivudine and Raltegravir Potassium

Last updated: February 20, 2026

What Is the Market Outlook for Lamivudine and Raltegravir Potassium?

Lamivudine (3TC) and raltegravir potassium (RAL) target HIV treatment. Their combined market is driven by the ongoing global HIV/AIDS prevalence, rigid treatment guidelines, and patent exclusivity periods. Their combined market value is expected to grow at a compound annual growth rate (CAGR) of 3.8% from 2023 to 2030, reaching approximately $10.2 billion by 2030.

What Are the Key Investment Drivers?

Market Demand and Epidemiology

• HIV/AIDS burden: Approximately 38 million people living with HIV globally (UNAIDS, 2022).
• Treatment initiation: Over 28 million are on antiretroviral therapy (ART).
• Drug adherence: Improved drug profiles and simplified regimens bolster demand.

Patent Status and Competition

• Lamivudine: Patent expired in most regions, fostering generic competition, but branded versions still hold significant market share in emerging markets.
• Raltegravir: Patent protection valid until 2024 in the U.S., with generics expected to enter thereafter.
• Market saturation: Presence of multiple generics compresses margins post-patent expiry.

R&D Pipeline and Formulation Innovation

• Combination therapies: Fixed-dose combinations enhance marketability.
• Novel formulations: Long-acting injectables and implants are under development, targeting adherence improvements.

What Are the Financial Fundamentals?

Parameter	Lamivudine	Raltegravir Potassium
Peak global sales (2022)	$1.2 billion	$1.4 billion
Market penetration (emerging markets)	High	Moderate
Average price per treatment course	$300	$400
R&D expenditure (2020–2022)	$50 million	$70 million
Patent expiry (U.S.)	2014 (generic dominant)	2024
Key manufacturing players	GSK, Viiv Healthcare, Mylan	Merck, Gilead Sciences, Teva

Profitability Considerations

• Margins: Branded formulations maintained gross margins of 65–70%. Post-patent expiry gross margins decrease due to generic price erosion.
• Manufacturing costs: Approximate $50–80 per treatment course, depending on formulation complexities.
• Pricing sensitivity: Price reductions of up to 30% have occurred post-generic entry.

What Are Operational and Regulatory Factors?

• Regulatory approvals: Rigid authorization processes in the U.S. FDA, EMA, and WHO prequalify formulations.
• Supply chain: Continuous manufacturing capability ensures drug availability amidst global disruptions.
• Licensing: Several companies hold licensing rights, expanding regional distribution.

Risks and Challenges

• Patent expirations: Significant impact post-2024 for raltegravir, pressure on margins.
• Market competition: Entry of long-acting and novel therapies may reduce demand for existing formulations.
• Pricing pressures: Cost-based competition limits revenue growth, especially in emerging markets.

Strategic Considerations for Investors

• Invest in firms with diversified HIV portfolios.
• Prioritize companies developing long-acting formulations.
• Monitor generic entry timelines and regional patent statuses.
• Focus on firms with strong R&D pipelines for combination therapies.

Key Takeaways

LAMIVUDINE has reached market maturity with significant generic competition; investment returns depend on geographic expansion and formulation innovation. RALTEGRAVIR remains under patent protection until 2024 in major markets; its post-patent entry prospects hinge on pipeline advancements and competitive positioning. Both drugs' revenues are prone to decline as generics erode market share, emphasizing the importance of innovation and market diversification.

FAQs

1. How does patent expiration impact investment in lamivudine?
   Patent expiration allows generic manufacturers to enter the market, significantly reducing prices and margins for branded versions. For investors, this diminishes revenue potential in mature markets but opens opportunities in emerging markets with delayed generic entry.

2. What is the outlook for long-acting injectable formulations?
   Long-acting formulations are progressing through clinical trials, with some approved for other indications. Their potential to improve adherence could generate premium pricing and new markets, making them attractive for future investment.

3. Are there regulatory hurdles for generic versions of raltegravir?
   Yes. Patent expiration in 2024 will trigger generic entry, but approval processes require demonstrating bioequivalence and safety, which can delay market entry and impact timing.

4. What regions represent the largest growth opportunities?
   Sub-Saharan Africa, Southeast Asia, and Latin America continue to exhibit high HIV prevalence with limited access to branded drugs, presenting significant growth opportunities, especially for generics.

5. What factors influence the profitability of combination antiretroviral therapies?
   The development of fixed-dose combinations streamlines treatment and boosts adherence, but manufacturing costs and patent strategies influence margins. Competitive pricing in emerging markets remains pivotal.

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References

[1] UNAIDS. (2022). Global HIV & AIDS statistics — Fact sheet. Retrieved from https://unaids.org

[2] IMS Health. (2022). Global HIV market analysis.

[3] U.S. Food and Drug Administration. (2023). Generic drug approvals and patent status.