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:	59
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
MSD Pharmaceuticals LLC	PHASE4
Fundacion IDEAA	PHASE4
Fundacin Husped	PHASE4

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			Y
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806-001	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	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
Israel	233334
Dominican Republic	P2012000256
Japan	5281718
Cyprus	2019026
Hungary	E025336
Finland	C20190021
Chile	2012002744

Supplementary Protection Certificates for DORAVIRINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	C201930027	Spain		PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA EN COMBINACION CON LAMIVUDINA Y TENOFOVIR DISOPROXILO FUMARATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122
2552902	PA2019506,C2552902	Lithuania		PRODUCT NAME: DORAVIRINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1332 20181122
2924034	25/2019	Austria		PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON IN KOMBINATION MIT LAMIVUDIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT TENOFOVIR ODER EINEM ESTER DAVON, INSBESONDERE EINEM DISOPROXILESTER ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON, INSBESONDERE EINEM FUMARATSALZ; REGISTRATION NO/DATE: EU/1/18/1333/001-002 (MITTEILUNG) 20181126
2924034	PA2019507	Lithuania		PRODUCT NAME: DORAVIRINAS ARBA JO DRUSKA, LAMIVUDINAS ARBA JO DRUSKA, TENOFOVIRAS ARBA JO ESTERIS, YPAC DIZOPROKSILO ESTERIS ARBA JO DRUSKA, YPAC FUMARATO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1333 20181122
2552902	24/2019	Austria		PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1333/001-002 (MITTEILUNG) 20181126
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	300980	Netherlands		PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126

Market Dynamics and Financial Trajectory of DORAVIRINE

Last updated: February 16, 2026

Doravirine, an NNRTI developed by Merck (known as MSD outside the U.S. and Canada), targets HIV-1 infection. Since its approval in the U.S. in August 2018, the drug's market position has seen fluctuations driven by competition, pricing strategies, and evolving treatment guidelines.

Market Position and Competitive Landscape

Approval and Indications:

• Approved in 2018 by the FDA for use in combination with other antiretrovirals.
• Indicated for treatment of HIV-1 infection in adult patients.
• Approved in multiple regions, including the U.S., EU, and Japan, with variations in dosing and combination partners.

Competitive Drugs:

• Dolutegravir (ViiV's Tivicay, GSK's Juluca) dominates the first-line HIV market.
• Rilpivirine (Janssen) remains a competitor in NNRTI segments.
• Recent entries include fostemsavir and long-acting injectables (cabotegravir/rilpivirine).

Market Share:

• As of 2022, Doravirine held an estimated 5-10% share of the NNRTI segment, which itself accounts for approximately 15-20% of the overall HIV market.
• The drug's adoption is restrained by competition from integrase strand transfer inhibitors (INSTIs) like dolutegravir, which demonstrate higher efficacy and tolerability.

Market Drivers

1. Patent and Exclusivity:

   • Patent expiry is not imminent; primary patents extend through 2030.
   • Market exclusivity supports ongoing sales, with potential generic entrants limited until mid-2030s.

2. Pricing and Reimbursement:

   • Listed at approximately $3,500 per month in the U.S. (as of 2022).
   • Reimbursement depends on regional pricing negotiations, impacting penetration.

3. Clinical Positioning:

   • Niche use in cases with contraindications to other NNRTIs.
   • Used in fixed-dose combinations with other antiretrovirals.

4. Regulatory Approvals:

   • Expanded approvals for pediatric indications and specific regimens expand potential markets.

Market Challenges

• Competition from INSTIs: Dolutegravir-based regimens outperform in efficacy, side-effect profile, and adherence metrics.
• Market Penetration: Limited by clinician familiarity with newer agents and prescribing inertia.
• Pricing Pressure: Generics anticipated post-patent expiry will reduce prices, impacting revenue.

Financial Trajectory

Sales Performance:

• Merck's HIV franchise reported $4.2 billion in 2021. Doravirine-specific sales remain modest, estimated below $100 million annually.
• Sales growth trajectory has been slow due to competitive pressures and market saturation.

Forecasts:

• By 2030, sales are expected to decline significantly as generics enter and newer therapies gain prevalence.
• A compound annual growth rate (CAGR) of roughly -3% to -5% forecasted from 2022-2027.

Pipeline and Future Potential:

• No immediate pipeline enhancements reported for Doravirine.
• Emerging long-acting injectable therapies threaten oral NNRTIs' market share.

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Summary Table

Aspect	Details
Approval Year	2018
Indications	HIV-1 infection in adults
Market Share (2022)	5-10% of NNRTI segment
Pricing (U.S.)	~$3,500/month
Patent Expiry	2030 (expected)
Sales (2021)	Under $100 million
Growth Outlook (2022-2027)	CAGR of approximately -4%

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Key Takeaways

• Doravirine holds a niche position, primarily benefiting from patent protections and limited direct competition.
• The drug's financial prospects face diminishing returns due to competition and pricing pressures.
• The market dynamics favor later-generation therapies with better efficacy and tolerability, reducing long-term domestic sales potential for Doravirine.
• Strategic focus for Merck involves maintaining current approvals and exploring new combination regimens to sustain revenue.
• The impending entry of long-acting injectables represents a significant threat to oral NNRTIs, including Doravirine.

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FAQs

1. What factors limit Doravirine's market expansion?
Competitive efficacy of integrase inhibitors, clinician prescribing habits, and limited differentiation restrict growth.

2. When will generics likely enter the market?
Post-2030, assuming patent expiry remains unchallenged, generic versions could appear, driving prices down.

3. Are there ongoing clinical trials for Doravirine?
Yes, ongoing studies explore combination regimens and new indications; however, no major phase 3 trials are currently announced.

4. How does Doravirine compare with other NNRTIs?
It has a favorable side-effect profile and fewer drug-drug interactions but offers no significant efficacy advantage over competitors like rilpivirine.

5. What is the outlook for Doravirine's long-term sales?
Sales are expected to decline mid-decade as newer therapies and generics reduce market share.

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Sources

1. U.S. Food and Drug Administration (FDA). "FDA approves Merck's DORAVIRINE Tablets for treatment of HIV-1 infection." 2018.
2. Merck Annual Reports (2021–2022).
3. IQVIA sales data.
4. Global HIV Market Reports, 2022.
5. Industry analyst estimates.