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

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			Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes			Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes			Y	Y

International Patents for doravirine; lamivudine; tenofovir disoproxil fumarate

Country	Patent Number	Title	Estimated Expiration
Poland	3383397
Serbia	62466	FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE DORAVIRIN, TENOFOVIR DIZOPROKSIL FUMARAT I LAMIVUDIN (PHARMACEUTICAL COMPOSITIONS CONTAINING DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE)
Ecuador	SP12012201

Supplementary Protection Certificates for doravirine; lamivudine; tenofovir disoproxil fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2552902	CR 2019 00025	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126
2924034	CR 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
2552902	2019/020	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1332/001, EU/1/18/1332/002, EU/1/18/1333/001, EU/1/18/1333/002, 20181122

Doravirine; lamivudine; tenofovir disoproxil fumarate Market Analysis and Financial Projection

Last updated: February 13, 2026

Market Dynamics and Financial Trajectory for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Market Overview

The combination of Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate (D/L/TDF) is an antiretroviral therapy (ART) used primarily for HIV-1 treatment. Market adoption is driven by the increasing global HIV prevalence, evolving treatment guidelines, patent status, and competitive landscape.

Market Demand Drivers

1. Rising HIV Prevalence: The WHO estimates over 38 million people globally living with HIV as of 2021. The steady growth in diagnosed cases sustains demand for effective ART regimens (WHO, 2021).

2. Evolving Treatment Guidelines: The U.S. National Institutes of Health (NIH) updates guidelines favor regimens with improved tolerability and resistance profiles, favoring integrase strand transfer inhibitors (INSTIs), including Doravirine, over older NNRTIs.

3. Regulatory Approvals and Labeling:

   • FDA Approval: Doravirine-based regimens received FDA approval in 2018 with D/TDF as a preferred initial regimen for HIV.
   • EMA Approvals: Similar approvals in Europe support market penetration, with ongoing extensions for broader indications.

4. Patent and Market Exclusivity:

   • The original patents of companies like Merck (producer of D/TDF-based products) are set to expire between 2025-2030, opening markets for generics and biosimilars.
   • Patent litigations and licensing agreements influence market share shifts.

Competitive Landscape

• Main Products: Dolutegravir-based regimens dominate the market, including Genvoya and Tivicay, leveraging superior efficacy and tolerability.
• Generics Entry: As patents lapse, generic versions of D/TDF-based regimens are expected to enter markets in 2025-2030, intensifying price competition.
• Emerging Alternatives: New drugs like Cabotegravir and Islatravir are projected to challenge existing therapies due to convenience or improved resistance profiles.

Market Size and Revenue Projections

• Current Market Size: The global HIV drug market was valued at approximately $22 billion in 2021, with D/TDF regimens accounting for about 20–25%—roughly $4.4–5.5 billion.

• Forecasts:

  • The market is projected to grow at a compound annual growth rate (CAGR) of 4–6% through 2028, reaching $30 billion globally.
  • D/L/TDF segment is expected to decline post-patent expiry due to generics but may be offset by increased global HIV diagnosis and treatment expansion.

Revenue Trajectory

• 2018-2022: Initial rapid uptake with peak revenues due to innovative formulation and label expansion.
• 2023-2027: Market begins plateauing; sales stabilize as competition increases and patent cliffs approach.
• Post-2027: Revenues decrease unless offset by new formulations, fixed-dose combinations with improved profiles, or new indications.

Pricing Dynamics

• Pricing Trends:
  • Branded D/TDF regimens retailed at $15,000–$20,000 annually per patient in high-income countries.
  • Generic versions could reduce prices by 50–70% upon patent expiration.
• Market Access Factors:
  • Subsidized programs in low- and middle-income countries (LMICs) lower effective prices.
  • Negotiations with payers influence affordability and uptake.

Regulatory and Policy Impact

• Patent filings, extensions, and potential compulsory licenses in LMICs pose a risk to revenue stability.
• WHO prequalifications and inclusion in Essential Medicines Lists expand global access, impacting revenue distribution.

Risks and Opportunities

Risks	Opportunities
Patent expiry reduces exclusivity; generics enter.	Adoption of fixed-dose combinations enhances adherence.
Pricing pressure from generics.	Market expansion driven by global HIV treatment scale-up.
Competition from newer agents.	Development of long-acting formulations improves patient compliance.

Conclusion

The financial trajectory of D orav irine; Lamivudine; Tenofovir Disoproxil Fumarate hinges on patent status, evolving HIV treatment paradigms, and geographic market expansion. While current revenues are substantial, long-term profitability will depend on successful navigation of patent cliffs, generic entry, and innovation in formulations.

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Key Takeaways

• The D/L/TDF regimen currently generates significant revenue driven by global HIV treatment needs.
• Patent expiration from 2025 to 2030 is poised to diminish branded revenues, with generics likely to dominate in the subsequent decade.
• Market growth continues, primarily fueled by expanding treatment access in LMICs and new formulations, despite competition from newer drugs.
• Pricing strategies adapt to regional market conditions, with significant discounts in LMICs and premium pricing in high-income countries.
• Future revenue streams depend on regulatory developments, new formulations, and the ability to maintain market share against competitors.

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5 FAQs

Q1: When is the patent for D/TDF set to expire?
A1: Patents for D/TDF-based formulations are expected to expire between 2025 and 2030, allowing generics to enter the market.

Q2: How does the market share of D/L/TDF compare to other HIV regimens?
A2: D/TDF-based regimens hold roughly 20–25% of the global HIV drug market, with integrase inhibitor-based therapies like Dolutegravir accounting for larger shares.

Q3: What factors influence the pricing of D/L/TDF medications?
A3: Pricing depends on patent status, regional health policies, negotiated discounts, and whether the product is a brand or generic.

Q4: What are the prospects for D/L/TDF in low-income countries?
A4: Widespread access programs and voluntary licensing facilitate adoption, although prices are lower and market penetration is more sensitive to global health policies.

Q5: Which therapies could threaten D/L/TDF market share in the future?
A5: Long-acting injectables like Cabotegravir and new oral agents such as Islatravir could displace D/L/TDF due to better adherence and resistance profiles.

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References

1. WHO. HIV/AIDS Data and Statistics, 2021.
2. U.S. FDA. Approval history and labeling for Doravirine-based regimens.
3. IMS Health. Global HIV Drug Market Reports, 2018-2022.
4. Deloitte. Future Trends in HIV Treatment Market, 2022.
5. European Medicines Agency. Regulatory decisions and approvals, 2021.