Doravirine; lamivudine; tenofovir disoproxil fumarate - Generic Drug Details

What are the generic drug sources for doravirine; lamivudine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Doravirine; lamivudine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Doravirine; lamivudine; tenofovir disoproxil fumarate has one hundred and one patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for doravirine; lamivudine; tenofovir disoproxil fumarate

International Patents:	101
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	15
DailyMed Link:	doravirine; lamivudine; tenofovir disoproxil fumarate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for doravirine; lamivudine; tenofovir disoproxil fumarate

Constraining patent/regulatory exclusivity:

8,486,975

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 doravirine; lamivudine; tenofovir disoproxil fumarate

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

Sponsor	Phase
Jos Antonio Mata Marn	PHASE3
Instituto Mexicano del Seguro Social	PHASE3
Instituto Mexicano del Seguro Social	PHASE4

See all doravirine; lamivudine; tenofovir disoproxil fumarate clinical trials

Pharmacology for doravirine; lamivudine; tenofovir disoproxil fumarate

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for doravirine; lamivudine; tenofovir disoproxil fumarate

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

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

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DELSTRIGO	Tablets	doravirine; lamivudine; tenofovir disoproxil fumarate	100 mg/300 mg/ 300 mg	210807	1	2022-08-30

US Patents and Regulatory Information for doravirine; lamivudine; tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	8,486,975		Y	Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	10,603,282		Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	10,842,751		Y

International Patents for doravirine; lamivudine; tenofovir disoproxil fumarate

Country	Patent Number	Title	Estimated Expiration
Portugal	2924034
Nicaragua	201200146
Honduras	2012002039
Lithuania	2924034

Supplementary Protection Certificates for doravirine; lamivudine; tenofovir disoproxil fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2552902	2019C/004	Belgium		PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2924034	2019018	Norway		PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV I KOMBINASJON MED LAMIVUDIN OG I KOMBINASJON MED TENOFOVIRDISOPROKSIL FUMARAT; REG. NO/DATE: EU/1/18/1333/001-2 20181213
2552902	SPC/GB19/023	United Kingdom		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/18/1332/001-002 20181122; UK PLGB 53095/0045 20181122
2552902	PA2019506	Lithuania		PRODUCT NAME: DORAVIRINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1332 20181122

Market Dynamics and Financial Trajectory for Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate

Last updated: July 28, 2025

---

Introduction

The combined use of doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF) represents a cornerstone in antiretroviral therapy (ART) for HIV treatment. The evolving landscape of HIV medicinal options, driven by advancements in drug formulations, regulatory approvals, and shifting market demands, shapes the financial and commercial prospects of these medicines. This analysis examines the current market dynamics and forecasts the financial trajectory for this drug combination, emphasizing key market drivers, competitive landscape, regulatory trends, and future growth opportunities.

---

Market Overview

The global HIV therapeutics market is sizable and mature, with an estimated valuation of approximately USD 21 billion in 2022 and expected compound annual growth rates (CAGR) of 4-6% over the coming five years (1). Within this segment, antiretroviral drugs like doravirine, lamivudine, and TDF occupy a significant share, owing to their proven efficacy, safety profile, and inclusion in first-line treatment regimens.

Doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Merck, gained FDA approval in 2018 for HIV-1 infection, aiming to offer a tolerability-enhanced alternative to existing NNRTIs. Lamivudine and TDF, both nucleoside reverse transcriptase inhibitors (NRTIs), have been long-standing staples in HIV therapy, with broad generic availability and well-established safety and efficacy.

---

Market Dynamics

1. Therapeutic Market Trends

The dominant market trend emphasizes simplicity and adherence, favoring fixed-dose combinations (FDCs). The combination of doravirine, lamivudine, and TDF forms the basis of several FDCs, such as Delstrigo (Merck), approved for once-daily oral administration, improving patient compliance. The push toward once-daily, 3-in-1 regimens supports sustained demand and revenue streams (2).

Furthermore, the paradigm shift toward integrase strand transfer inhibitor (INSTI)-based regimens, such as bictegravir-based therapies, poses competitive pressure on NNRTI-based combinations but concurrently emphasizes the necessity for next-generation formulations with improved tolerability, resistance profiles, and drug-drug interaction profiles.

2. Competitive Landscape

Generic competition, especially for lamivudine and TDF, constrains profit margins but ensures broader access, particularly in low- and middle-income countries (LMICs). Gilead Sciences, Mylan (now part of Viatris), and others secure significant sales through generics, influencing pricing strategies for branded formulations.

Brand consolidation and pipeline diversification further influence market positioning. Merck's doravirine-based FDCs are positioned as alternatives for patients intolerant to other NNRTIs or those requiring robust resistance profiles; however, the expanding portfolio of INSTI and entry inhibitors restricts their market share growth.

3. Regulatory and Patent Landscape

Patent protections for doravirine and corresponding FDCs extend into the late 2020s, with potential for patent litigations or extensions, shaping market exclusivity periods. The expiration of patents for lamivudine and TDF has led to a proliferation of generics, intensifying price competition and squeezing margins for originators.

In LMICs, WHO prequalification and licensing agreements facilitate generic manufacturing, expanding access but reducing revenue potential for originator companies.

4. Pricing and Reimbursement

Pricing strategies are critical; in high-income regions, reimbursement policies enable premium pricing based on clinical advantages. Conversely, in LMICs, tiered pricing strategies and voluntary licensing boost volume sales but limit revenue per unit.

The increasing emphasis on value-based healthcare, alongside cost-effectiveness analyses, influences formulary decisions, favoring regimens with proven long-term cost savings and favorable safety profiles.

---

Financial Trajectory and Future Outlook

1. Revenue Projections

The revenue outlook for doravirine, lamivudine, and TDF combinations hinges on several factors:

• Market Penetration & Adoption: The continued preference for first-line, once-daily FDCs with improved tolerability will sustain demand. However, competition from integrase inhibitors like dolutegravir-based treatments, which boast superior resistance barriers and fewer side effects, poses challenges (3).

• Patent and Patent Expiries: As patent protections expire on TDF and lamivudine, significant generic market share is anticipated to dominate in the next 3-5 years, potentially reducing originator revenues by up to 50% or more, depending on regional market penetration.

• Pipeline and New Formulations: Next-generation drugs incorporating tenofovir alafenamide (TAF), which offers superior renal and bone safety over TDF, threaten to replace TDF-based products, leading to a decline in sales of TDF-based combinations.

The combination’s revenue is expected to decline gradually as generics permeate markets, but in the interim, strong adoption in institutional settings and advanced HIV care programs sustains profitability.

2. Growth Opportunities

Opportunities exist in expanding indications, including pre-exposure prophylaxis (PrEP). The adoption of doravirine-based PrEP formulations is under investigation, which could open new markets as HIV prevention strategies gain traction.

Moreover, research efforts aimed at optimizing dosing, reducing adverse effects, and improving resistance profiles can lead to next-generation formulations, potentially restoring revenue streams through improved efficacy and tolerability.

3. Challenges Impacting Financial Trajectory

Key hurdles include:

• Pricing pressures in global markets, especially as patents expire.

• Market saturation in mature regions.

• Competition from newer drug classes, notably INSTIs with enhanced safety profiles.

• Global health policies favoring generics for cost containment.

---

Regulatory Landscape

Regulatory agencies such as the FDA, EMA, and WHO influence market access and product lifecycle. Newly developed formulations must undergo rigorous clinical trials, with accelerated pathways available for formulations addressing unmet needs, such as resistance or tolerability issues.

Additionally, licensing and patent litigations could influence product availability and timing of market entry for generic equivalents, affecting revenue trajectories.

---

Conclusion

The market dynamics for doravirine, lamivudine, and TDF encompass a complex interplay of scientific, regulatory, and commercial factors. While current revenues are supported by established therapeutic niches, impending patent expirations and competition from newer drug classes necessitate strategic adaptations. The financial trajectory indicates a gradual decline in branded product revenues, countered by growth in generic markets and potential innovation in formulation and indications.

---

Key Takeaways

• The combined use of doravirine, lamivudine, and TDF remains relevant in HIV therapy, primarily in established markets and specific patient populations.

• Patent expiries and generic competition pressure originate revenues but facilitate broader access, especially in LMICs.

• The transition toward TAF-based regimens and INSTI-class drugs constrains future growth potential for TDF-based combinations.

• Opportunities in PrEP and next-generation formulations can sustain market relevance.

• Pharmaceutical companies must invest in pipeline innovation, targeted regulatory strategies, and geographic diversification to optimize long-term financial performance.

---

FAQs

1. How will patent expiries affect the market for doravirine, lamivudine, and TDF formulations?
Patent expiries will lead to increased generic competition, significantly reducing prices and revenue for branded products over the next 3-5 years, especially in mature markets. This shift is likely to make generics the default option in many regions, decreasing profit margins for originators.

2. Are there emerging alternatives that could replace doravirine-based formulations?
Yes. Integrase inhibitor-based formulations, such as bictegravir or dolutegravir combinations, with higher barriers to resistance and better safety profiles, are increasingly preferred as first-line therapies, challenging the market share of NNRTI-based combinations like doravirine.

3. What role does geographic diversity play in the financial prospects of this drug combination?
In high-income countries, premium pricing and reimbursement mechanisms support market sustainment, whereas in LMICs, licensing and generic manufacturing broaden access but limit revenue potential, making geographic diversification essential for revenue stability.

4. Could the combination be repurposed or expanded into new indications?
There is potential for using doravirine-based regimens in pre-exposure prophylaxis (PrEP), which could diversify revenue streams. Additionally, research into resistant or difficult-to-treat HIV strains may open further indications.

5. How does the shift toward TAF formulations impact this combination's future?
The superior safety profile of tenofovir alafenamide (TAF) likely leads to a decline in TDF-based products, including those with lamivudine, as TAF replaces TDF in new formulations, reducing long-term sales of TDF-containing combinations.

---

Sources
[1] Market Research Future. HIV Therapeutics Market Report. 2022.
[2] Merck. FDA Approval Announcement for Delstrigo. 2018.
[3] Gilead Sciences. Annual Report 2022.