PIFELTRO Drug Patent Profile

When do Pifeltro patents expire, and when can generic versions of Pifeltro launch?

Pifeltro is a drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this drug.

This drug has seventy-five patent family members in forty-five countries.

The generic ingredient in PIFELTRO is doravirine. Two suppliers are listed for this compound. Additional details are available on the doravirine profile page.

DrugPatentWatch^® Generic Entry Outlook for Pifeltro

Pifeltro was eligible for patent challenges on August 30, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 30, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PIFELTRO

International Patents:	75
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	4
Drug Prices:	Drug price information for PIFELTRO
What excipients (inactive ingredients) are in PIFELTRO?	PIFELTRO excipients list
DailyMed Link:	PIFELTRO at DailyMed

See drug prices for PIFELTRO

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

Constraining patent/regulatory exclusivity:

8,486,975

NDA:

210806

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 PIFELTRO

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

Sponsor	Phase
Chelsea and Westminster NHS Foundation Trust	Phase 3
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 4
Merck Sharp & Dohme Corp.	Phase 4

See all PIFELTRO clinical trials

Pharmacology for PIFELTRO

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

US Patents and Regulatory Information for PIFELTRO

PIFELTRO is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,486,975.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	PIFELTRO	doravirine	TABLET;ORAL	210806-001	Aug 30, 2018		RX	Yes	Yes	8,486,975		Y	Y
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806-001	Aug 30, 2018		RX	Yes	Yes

EU/EMA Drug Approvals for PIFELTRO

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 PIFELTRO

When does loss-of-exclusivity occur for PIFELTRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PIFELTRO around the world.

Country	Patent Number	Title	Estimated Expiration
Dominican Republic	P2012000256
Denmark	2924034
Israel	222030
Denmark	2552902
Croatia	P20161680
Serbia	54017	NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Slovenia	2552902

Supplementary Protection Certificates for PIFELTRO

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	2019019	Norway		PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/18/1332/001-2 20181213
2552902	C201930026	Spain		PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; 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
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
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	LUC00114	Luxembourg		PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1333 20181126
2924034	C02924034/01	Switzerland		PRODUCT NAME: DORAVIRIN, LAMIVUDIN UND TENOFOVIRDISOPROXIL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67066 17.12.2019

Market Dynamics and Financial Trajectory for PIFELTRO

Last updated: December 29, 2025

Executive Summary

PIFELTRO (generic name: remdesivir), originally developed by Gilead Sciences, is an antiviral medication primarily utilized for the treatment of severe COVID-19 cases. Its launch follows an evolving market landscape driven by pandemic dynamics, regulatory approvals, and competitive pressures. This report examines current market trends, projected financial trajectories, key drivers, challenges, and strategic considerations shaping PIFELTRO’s future in the pharmaceutical ecosystem.

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What Are the Current Market Dynamics for PIFELTRO?

Global COVID-19 Therapeutic Market Overview

The COVID-19 pandemic catalyzed unprecedented demand for antiviral agents, with remdesivir emerging as a frontline treatment. The COVID-19 therapeutic market is characterized by:

Aspect	Details
Market Size (2022)	Estimated at ~$8 billion worldwide with antivirals constituting the majority share (source: IQVIA)
Main Players (2023)	Gilead Sciences, Catalent, Becker & Co., generic manufacturers
Distribution Channels	Hospital pharmacies, specialty clinics, government stockpiles
Regulatory Landscape	Emergency Use Authorizations (EUAs), full FDA approvals, EMA approval processes

Regulatory Approvals Impacting PIFELTRO

• FDA: Approved in May 2020 for hospitalized COVID-19 patients.
• EMA: Conditional marketing authorization granted in July 2020.
• Other Jurisdictions: Use varies; licensed or authorized in over 60 countries.

Market Penetration and Adoption

Despite initial widespread use, recent data indicates declining prescribing rates due to:

• Emergence of new antivirals (e.g., Paxlovid)
• Variants with different clinical profiles
• Changing treatment guidelines restricting remdesivir use to severe cases

Implication: The demand curve for PIFELTRO is plateauing, necessitating strategic pivots for sustained revenues.

Competitive Landscape

Competitors	Key Attributes	Market Share (2023)	Notes
Remdesivir (Gilead)	Original branded product, high early adoption	~60%	Faces generic competition
Generic Remdesivir	Cost-effective alternatives	~25%	Increasingly prevalent globally
Other Antivirals	Paxlovid (Pfizer), Molnupiravir (Merck)	Remaining share	Oral agents gaining preference

Supply Chain & Manufacturing Factors

• Scaling Production: Gilead has increased remdesivir manufacturing capacity by 50% since 2021.
• Pricing Dynamics: US government initially paid ~$390 per treatment course; prices vary globally.
• Patent and Licensing: Generic manufacturers licensed in India and South Africa, affecting revenues in low-income markets.

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What Is the Financial Trajectory for PIFELTRO?

Revenue Projections (2023-2027)

Year	Estimated Revenue (USD millions)	Assumptions
2023	$1.2 billion	Peak pandemic demand tapering, high domestic sales, moderate international volume
2024	$900 million	Decline due to lower COVID-19 case severity, competition from oral antivirals
2025	$600 million	Shift to targeted use, increased generics market share
2026	$400 million	Strong generic penetration, regulatory shifts possibly impacting sales
2027	$300 million	Endemic adaptation, stable but reduced revenue stream

Key Revenue Drivers

• Regulatory Decisions: Potential approval for new indications (e.g., outpatient use) could temporarily boost sales.
• Market Penetration in Emerging Economies: Licensing deals and price reductions expand access.
• Evolving Treatment Guidelines: Restricting remdesivir to severe cases may constrain sales volume.

Cost Structure & Margin Outlook

Cost Element	% of Revenue	Notes
Manufacturing	20-25%	Capacity expansion investments ongoing
R&D	10-15%	Focus on new formulations, combination therapies
Marketing & Distribution	10%	Shifting toward targeted campaigns
Administrative & Overheads	15%	Stable, but with efficiency improvements possible

Projected gross margins are expected to decline from ~80% at peak to approximately 65-70% by 2027, factoring in generic competition and pricing pressures.

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What Are the Key Market Drivers and Challenges?

Drivers

Driver	Impact	Examples
Pandemic Dynamics	Sustains demand during acute phases	COVID waves in 2020-2022
Regulatory Approvals	Shapes market access	Emergency Use Authorizations, full approvals
Global Vaccination Rates	Reduced hospitalized cases	Global vaccination coverage of 67% (WHO, 2023)
Pricing and Reimbursement Policies	Incentivizes access	Gilead’s tiered pricing strategies
Emergence of New Therapies	Shifts competitive balance	Oral antivirals offer convenience

Challenges

Challenge	Impact	Mitigation Strategies
Market Saturation	Squeezes revenue	Diversify indications, combination therapies
Patent Expiry and Generic Competition	Price erosion	Strategic licensing, cost reduction
Changing Clinical Guidelines	Limits use	Focus on high-risk, severe cases
Supply Chain Disruptions	Production bottlenecks	Expand manufacturing capacity & diversify providers
Public Perception and Use	Fluctuations in demand	Education campaigns, stakeholder engagement

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How Does PIFELTRO Compare to Other COVID-19 Treatments?

Comparison Table: PIFELTRO vs Oral Antivirals

Attribute	PIFELTRO (Remdesivir)	Paxlovid (Pfizer)	Molnupiravir (Merck)
Administration	IV infusion	Oral	Oral
Indication	Hospitalized, severe COVID-19	Mild to moderate (high-risk)	Mild to moderate
Approval Date	May 2020	December 2021	October 2021
Pricing (US)	~$390/course	~$530/course	~$700/course
Market Trend	Declining	Increasing	Stabilizing
Ease of Use	Limited to hospitals	Home use	Home use

Implication for PIFELTRO

The convenience and expanding indications of oral treatments threaten the market share of PIFELTRO, especially in outpatient settings.

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What Strategies Will Shape PIFELTRO’s Future?

Strategy	Description	Potential Outcomes
Indication Expansion	Pursue approval for outpatient or mild cases	Increase sales volume
Combination Therapies	Develop synergistic regimens	Differentiation from competitors
Manufacturing Optimization	Cost reduction, capacity scaling	Improve margins
Global Access Programs	Tiered pricing, licensing	Expand emerging market footprint
Novel Delivery Systems	Inhalable formulations	New market segments

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Key Market and Financial Considerations

Consideration	Impact	Recommendation
Patent Lifecycle	Patent expiry in 2024-2026	Accelerate pipeline and licensing
Generic Competition	Erodes margins	Focus on high-margin markets and indications
Regulatory Environment	Potential for new approvals	Invest in pivotal trials for additional uses
Pricing Trends	Pressure on product value	Emphasize value-based reimbursement models

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Conclusion

PIFELTRO’s initial success was driven by pandemic-induced demand and regulatory support, but future growth hinges on market adaptation strategies amid declining COVID-19 cases, burgeoning competition, and evolving treatment paradigms. Its financial trajectory suggests a decline in revenue from peak pandemic levels, emphasizing the importance of expanding indications, innovating formulations, and developing complementary therapies.

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Key Takeaways

• Market Maturity: The global demand for remdesivir has peaked; future demand relies on expanding indications and geographical access.
• Revenue Outlook: Revenue projections show a downward trend stabilizing around $300-600 million by 2027, impacted by competition and changing clinical guidelines.
• Strategic Actions: Diversification into combination therapies, expansion into outpatient use, and increasing manufacturing efficiencies are critical.
• Competitive Positioning: Growing dominance of oral antivirals necessitates innovation in delivery and administration methods.
• Policy Environment: Patent expiries and licensing in emerging markets offer both challenges and opportunities for revenue diversification.

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Frequently Asked Questions (FAQs)

1. How will the patent expiry of remdesivir affect PIFELTRO’s financial performance?
Patent expiry, anticipated around 2024-2026, will likely lead to significant generic entry, reducing prices and margins. Strategic licensing, cost management, and indication expansion can mitigate revenue losses.

2. Is PIFELTRO still relevant given the rise of oral antivirals?
Yes, particularly for hospitalized or severe cases, and in regions where oral antivirals are less accessible. Additionally, ongoing research into new formulations and combinations can preserve its relevance.

3. What are the main challenges facing PIFELTRO’s future growth?
Key challenges include patent expiration, increasing generic competition, evolving clinical guidelines limiting use, and competition from more convenient oral agents.

4. Can PIFELTRO be used for diseases other than COVID-19?
Research and clinical trials are exploring its efficacy in other viral infections; diversification could provide alternative revenue streams.

5. What policies could impact PIFELTRO’s market access in emerging markets?
Pricing regulations, patent laws, and licensing agreements influence access. Tiered pricing and voluntary licensing can enhance market penetration.

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References

[1] IQVIA. COVID-19 therapeutic market analysis, 2022.
[2] FDA. Remdesivir (Veklury) approval and emergency use authorizations. 2020–2023.
[3] WHO. COVID-19 vaccination coverage statistics, 2023.
[4] MarketWatch. Remdesivir sales and forecasts, 2023.
[5] Pfizer. Paxlovid clinical data and market performance, 2023.