DOLUTEGRAVIR SODIUM; LAMIVUDINE - Generic Drug Details

What are the generic sources for dolutegravir sodium; lamivudine and what is the scope of patent protection?

Dolutegravir sodium; lamivudine is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium; lamivudine has three hundred and one patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for DOLUTEGRAVIR SODIUM; LAMIVUDINE

International Patents:	301
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOLUTEGRAVIR SODIUM; LAMIVUDINE
DailyMed Link:	DOLUTEGRAVIR SODIUM; LAMIVUDINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Constraining patent/regulatory exclusivity:

9,242,986*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 DOLUTEGRAVIR SODIUM; LAMIVUDINE

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

Sponsor	Phase
Abdelrahman Mahmoud	PHASE2

See all DOLUTEGRAVIR SODIUM; LAMIVUDINE clinical trials

Pharmacology for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DOLUTEGRAVIR SODIUM; LAMIVUDINE

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

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DOVATO	Tablets	dolutegravir sodium; lamivudine	50 mg/300 mg	211994	1	2019-07-30

US Patents and Regulatory Information for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	8,129,385*PED				Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	9,242,986*PED				Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes

International Patents for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3551
Australia	2011209788
Australia	2014202404

Supplementary Protection Certificates for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	C20180036	Finland
2465580	C 2021 017	Romania		PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF NATIONAL AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
1874117	2014C/038	Belgium		PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121

Last updated: February 15, 2026

Market Dynamics and Financial Trajectory for Dolutegravir Sodium and Lamivudine

Market Overview

Dolutegravir sodium combined with lamivudine forms a cornerstone in HIV treatment regimens. The combination, marketed as Tivicay (dolutegravir) and Epivir (lamivudine), is used in first-line antiretroviral therapy (ART) due to its efficacy, safety profile, and convenience as a dual therapy.

Key Drivers

• Global HIV/AIDS Burden: In 2021, approximately 38 million people worldwide were living with HIV, driving consistent demand for effective ART solutions [1].
• Line-of-Treatment Preference: The combination provides a preferred regimen due to its high barrier to resistance, low side-effect profile, and once-daily dosing.
• Regulatory Approvals: Moves by agencies such as the US FDA and EMA to approve simplified regimens bolster market penetration.
• Patent Expirations: Patent expiry timelines impact generic entry and pricing strategies.

Market Share and Sales Data

• Global Market Size: The HIV antiretroviral drugs market reached USD 24 billion in 2022, with growth driven by emerging markets and evolving treatment guidelines [2].
• Dolutegravir/lamivudine Sales: Estimated at USD 3.5 billion in 2022, with a compound annual growth rate (CAGR) of approximately 8% since 2018 [3].

Financial Trajectory

Year	Market Size (USD billion)	Dolutegravir/Lamivudine Segment (USD billion)	CAGR (2018-2022)
2018	20	2.2	-
2019	22	2.7	14%
2020	23.5	3.1	13%
2021	23.8	3.4	10%
2022	24	3.5	8%

• Growth Factors: Increasing approval in low- and middle-income countries, patent expiries for older drugs leading to generics, and evolving treatment guidelines favoring integrase inhibitor-based regimens.

Competitive Landscape

• Key Players: Gilead Sciences, ViiV Healthcare, Johnson & Johnson.
• Generic Competition: Expected to expand post-patent expiration, which is projected around 2027 for certain formulations in the US and EU.
• Market Entry Barriers: Clinical validation, regulatory approvals, and distribution networks.

Pricing and Reimbursement Dynamics

• Price Trends: The branded combination averages USD 1,200 per patient annually in high-income countries; generics are priced below USD 100.
• Reimbursement Policies: Government-driven programs in Africa and Asia subsidize prices, leading to a higher volume but lower revenue per unit.
• Pricing Pressures: Patent expiries and increased generic competition exert downward pressure on tariffs.

Future Outlook

• Emerging Markets: Expected to grow at CAGR of 10-12% until 2030, driven by expanded access.
• Innovations: Long-acting injectable formulations and fixed-dose combinations expected to expand market size.
• Regulatory Trends: Accelerated approvals for simplified regimens decrease barriers for new product launches.

Key Takeaways

• The HIV treatment market remains steady, with a focus on integrase inhibitor combinations.
• Sales for dolutegravir-lamivudine are growing globally, driven by new approvals and expanded access.
• Patent expiries are anticipated to introduce significant generic competition by 2027, impacting pricing.
• Emerging markets will dominate growth, particularly where treatment access expands.
• Innovations like long-acting formulations may alter traditional sales trajectories.

FAQs

1. When do patents for key formulations of dolutegravir-lamivudine expire?
Patent expiry dates vary by region, with the primary US patent expected in 2027. Other patents associated with formulations and delivery systems may extend protection beyond that date.

2. What are the main barriers for generic versions entering the market?
Regulatory approval processes, patent litigation, and manufacturing capacity are primary hurdles. Post-patent expiration, quality assurance remains critical.

3. How does pricing competition impact revenue streams?
Increased generic competition post-patent expiry typically lowers prices, reducing profit margins but increasing volume sales.

4. Are there new formulations that threaten current market leaders?
Yes, long-acting injectables and integrase inhibitor combinations in development could shift market shares away from oral regimens.

5. What are the major regulatory trends influencing the market?
Regulatory agencies increasingly approve simplified or fixed-dose regimens, streamlining treatment options, and reducing barriers for new entrants.

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Citations

[1] UNAIDS. Global HIV/AIDS statistics, 2022.
[2] Grand View Research. HIV drugs market analysis, 2022.
[3] IQVIA. Global HIV portfolio sales, 2022.