DORAVIRINE - Generic Drug Details

What are the generic drug sources for doravirine and what is the scope of freedom to operate?

Doravirine is the generic ingredient in two branded drugs marketed by Msd Merck Co and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Doravirine has seventy-five patent family members in forty-five countries.

Two suppliers are listed for this compound.

Summary for DORAVIRINE

International Patents:	75
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	58
Drug Prices:	Drug price trends for DORAVIRINE
What excipients (inactive ingredients) are in DORAVIRINE?	DORAVIRINE excipients list
DailyMed Link:	DORAVIRINE at DailyMed

See drug prices for DORAVIRINE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DORAVIRINE

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

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

Sponsor	Phase
Instituto Mexicano del Seguro Social	PHASE3
Jos Antonio Mata Marn	PHASE3
Organization providing support methodology coordination (Institut Pierre Louis d'Epidmiologie et de Sant Publique)	PHASE2

See all DORAVIRINE clinical trials

Pharmacology for DORAVIRINE

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

Anatomical Therapeutic Chemical (ATC) Classes for DORAVIRINE

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

US Patents and Regulatory Information for DORAVIRINE

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	PIFELTRO	doravirine	TABLET;ORAL	210806-001	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			Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes			Y	Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes			Y

EU/EMA Drug Approvals for DORAVIRINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Pifeltro	doravirine	EMEA/H/C/004747Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.	Authorised	no	no	no	2018-11-22

International Patents for DORAVIRINE

Country	Patent Number	Title	Estimated Expiration
Hungary	E031785
Hong Kong	1209121
Denmark	2924034
New Zealand	602670	Non-nucleoside reverse transcriptase inhibitors
Japan	2013209405

Supplementary Protection Certificates for DORAVIRINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2552902	24/2019	Austria		PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1333/001-002 (MITTEILUNG) 20181126
2924034	132019000000062	Italy		PRODUCT NAME: DORAVIRINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE IN COMBINAZIONE CON LAMIVUDINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE IN COMBINAZIONE CON TENOFOVIR O UN SUO ESTERE, IN PARTICOLARE UN ESTERE DI DISOPROXIL O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE UN SALE FUMARATO(DELSTRIGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1333/001-002, 20181127
2552902	2019019	Norway		PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/18/1332/001-2 20181213
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
2924034	CA 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126

Market Dynamics and Financial Trajectory for DORAVIRINE

Last updated: July 29, 2025

Introduction

Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) primarily used in the treatment of HIV-1 infection. Approved notably by the U.S. Food and Drug Administration (FDA) in 2018 as part of a fixed-dose combination, such as Atripla (efavirenz, tenofovir, emtricitabine) and other regimens, doravirine has garnered attention for its efficacy and favorable safety profile. This review analyzes the market landscape, competitive positioning, and financial prospects for doravirine, considering evolving HIV treatment paradigms, competitive dynamics, and regulatory trends.

Market Landscape and Key Drivers

Global HIV Treatment Market Overview

The global HIV therapeutic market was valued at approximately USD 21 billion in 2021 and is projected to reach USD 25 billion by 2026, with a compound annual growth rate (CAGR) of around 3% (source: MarketWatch). The segment is characterized by sustained demand driven by the persistent prevalence of HIV/AIDS, particularly in regions such as sub-Saharan Africa, North America, and parts of Asia. The market's growth hinges on factors including patent expirations, emergence of novel therapeutics, and the shift toward simplified, all-oral regimens.

Positioning of Doravirine

Initially launched by Merck & Co., doravirine entered a competitive landscape dominated by long-established NNRTIs like efavirenz and newer integrase inhibitors such as dolutegravir. Its standout features include a favorable side-effect profile, low drug-drug interactions, and efficacy comparable to second-generation NNRTIs. This positioning caters to patients intolerant to previous NNRTIs and those seeking simplified dosing.

Competitive Dynamics

The core competitors include:

• Etravirine and Rilpivirine (other NNRTIs): Offering alternative mechanisms but often associated with adverse effects like neuropsychiatric symptoms or drug resistance.
• Dolutegravir (DTG): An integrase strand transfer inhibitor with superior tolerability and higher barrier to resistance, now often preferred as first-line therapy.
• Bictegravir and Cabotegravir: Emerging long-acting injectables expanding options.

Doravirine's nicheFocus as a tolerable NNRTI is challenged by the rise of integrase inhibitors, which dominate guidelines, and injectables that improve adherence.

Regulatory and Clinical Development Trajectory

The FDA approval in 2018 significantly propelled doravirine into the market. Subsequently, the drug received approvals in several other countries, bolstered by clinical data demonstrating non-inferiority and tolerability. Ongoing trials explore its use in initial and treatment-experienced patients, potentially broadening its application.

Financial Trajectory and Revenue Prognosis

Historical and Current Revenue Performance

Since launch, doravirine's revenue remained modest, reflective of its niche positioning. Merck reported approximately USD 350 million in sales for doravirine-based regimens in 2021, with subsequent growth in 2022 driven by expanded indications and regional approvals. Market analysts project revenues to increase at a CAGR of 8-12% over the next five years, reaching USD 600-700 million by 2027.

Factors Supporting Revenue Growth

• Market Penetration in Expansion Regions: Growing access to HIV treatment in Africa and Asia opens opportunities.
• Line Extension Opportunities: Combination formulations with other antiretrovirals could boost sales.
• Patent Life and Exclusivity: Patent protections extend until the late 2020s, providing a window for sustained revenues.

Challenges Limiting Growth

• Intense Competition from Integrase Inhibitors: Dolutegravir-based regimens are increasingly preferred, capturing a substantial market share.
• Generic Penetration: Patent expiry or potential patent challenges could erode market share, especially in lower-income regions.
• Clinical Preference Trends: The shift toward long-acting injectables (e.g., cabotegravir) may diminish the role of oral NNRTIs like doravirine.

Strategic Opportunities and Risks

Opportunities

• Combination Therapies: Developing fixed-dose combinations incorporating doravirine could enhance adherence and market reach.
• Special Populations: Clinical trials targeting adolescents, treatment-experienced, or drug-resistant populations could deepen market penetration.
• Regional Expansion:Enter emerging markets with high HIV burdens where treatment options are expanding.

Risks

• Evolving Treatment Guidelines: Favoring integrase inhibitors, which may overshadow NNRTIs.
• Pricing Pressures: Competitive pricing or biosimilar entries could commoditize doravirine.
• Regulatory Challenges: Delays or restrictions in regional approvals can hamper sales growth.

Regulatory and Market Trends

The increasing adoption of integrase inhibitors, and the advent of long-acting injectables, are transforming the therapeutic landscape. Regulatory agencies are emphasizing simplified regimens, safety profiles, and resistance profiles, which advantage drugs like doravirine with favorable tolerability. Nonetheless, the competitive momentum favors agents with broader efficacy and ease of administration.

Conclusion

Doravirine occupies a specialized niche within the HIV market, supported by its tolerability and non-inferior efficacy. Its financial trajectory, while modest today, is poised for incremental growth driven by regional expansion, combination formulations, and clinical positioning. However, drugs like dolutegravir and long-acting injectables present formidable competitive challenges. Strategic adaptation, including pipeline development and regional penetration, will be critical to maximizing its market potential.

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Key Takeaways

• Market Position: Doravirine’s niche is rooted in its tolerability, offering an alternative for patients intolerant to other NNRTIs or those seeking simplified regimens.
• Revenue Outlook: Projected to grow at a double-digit CAGR pre-2027, reaching around USD 700 million, contingent on competitive dynamics and patent longevity.
• Competitive Pressures: Rising preference for integrase inhibitors and long-acting injectables will influence market share and sales.
• Strategic Focus: Developing combination therapies, expanding into emerging markets, and addressing drug-resistant patient segments could drive growth.
• Risks: Patent expiry, pricing pressures, and evolving treatment guidelines favoring newer modalities pose threats to sustained revenue.

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FAQs

1. What differentiates doravirine from other NNRTIs?
   Its improved safety profile, lower incidence of neuropsychiatric side effects, and fewer drug-drug interactions set doravirine apart from older NNRTIs like efavirenz and rilpivirine.

2. How does doravirine compare to integrase inhibitors in efficacy?
   Clinical trials demonstrate non-inferiority in viral suppression; however, integrase inhibitors currently dominate the market due to higher barriers to resistance and evolving guidelines.

3. What is the potential for doravirine in long-acting formulations?
   Currently, no long-acting doravirine formulations are approved. However, research into such options could enhance its offerings and market share.

4. How might patent expiry influence doravirine’s market?
   Patent expiry could lead to generic competition, significantly reducing sales unless Merck develops next-generation formulations or expands indications.

5. Which regions offer the greatest growth opportunities for doravirine?
   Emerging markets in Africa and Asia present the most significant growth prospects, driven by increasing access to HIV treatment and unmet medical needs.

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Sources

1. MarketWatch. “Global HIV Therapeutics Market Size Report, 2022-2027.”
2. Merck & Co. Quarterly Financial Reports, 2021-2022.
3. U.S. Food and Drug Administration. “FDA Approval for Doravirine,” 2018.
4. World Health Organization. “HIV/AIDS factsheet,” 2022.
5. EvaluatePharma. “HIV Market Outlook,” 2022.