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-three patent family members in forty-four 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:	73
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	4
Patent Applications:	468
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
Merck Sharp & Dohme Corp.	Phase 4
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	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/004747 Pifeltro 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

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
Mexico	2012011379	INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA. (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS.)
Costa Rica	20120503	INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
China	102971308	Non-nucleoside reverse transcriptase inhibitors
Cyprus	1118774
Taiwan	201139409	Non-nucleoside reverse transcriptase inhibitors
Spain	2609636
Cyprus	2019025

Supplementary Protection Certificates for PIFELTRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2552902	122019000038	Germany		PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1332-1333 20181122
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
2552902	CA 2019 00025	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126
2924034	122019000042	Germany		PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN UND TENOFOVIR-DISOPROXIL-FUMARAT; REGISTRATION NO/DATE: EU/1/18/1333 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
2552902	C02552902/01	Switzerland		PRODUCT NAME: DORAVIRIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67065 17.12.2019
2924034	19C1025	France		PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE L0181126 AMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 2

Market Dynamics and Financial Trajectory for Pifeltro

Introduction to Pifeltro

Pifeltro, branded as doravirine, is a significant addition to Merck's virology portfolio, particularly in the treatment of HIV-1. Approved by the FDA in 2018, Pifeltro is an oral medication designed for adult patients who have never received antiretroviral treatment, marking a crucial step in Merck's efforts to bolster its virology business.

Market Context: HIV Treatment Landscape

The global HIV drugs market is a dynamic and growing sector, driven by increasing patient populations, new product launches, and government-run awareness programs. As of 2023, the global HIV drugs market size was valued at $34.13 billion and is projected to grow to $58.24 billion by 2032, with a CAGR of 6.2%[4].

Approval and Clinical Data

Pifeltro received FDA approval based on data from the Phase 3 DRIVE-AHEAD and DRIVE-FORWARD studies. In these studies, Pifeltro demonstrated non-inferiority to other established treatments. For instance, in the DRIVE-FORWARD study, Pifeltro showed non-inferiority to Johnson & Johnson's Prezista plus ritonavir when administered in combination with either Gilead's Truvada or Epzicom/Kivexa[1].

Market Reception and Challenges

Despite the positive clinical data, the market reception of Pifeltro has been mixed. While it is expected to be well-received by physicians due to its inclusion of treatment-naïve patients, concerns about resistance to doravirine have been raised. In the clinical trials, 11 participants showed the emergence of doravirine-associated resistance substitutions, which could impact its long-term efficacy[1].

Financial Projections

Market research firm GlobalData predicts that Pifeltro, along with Delstrigo (a fixed-dose combination tablet that includes doravirine), will generate around $500 million in combined sales across the seven major pharmaceutical markets by 2023. This figure, although significant, is not expected to match the sales of highly successful competitors like Gilead's Atripla[1].

Impact on Merck's Virology Business

Merck's virology business has faced challenges in recent years. The sales of its HIV drug Isentress (raltegravir) were flat in the first half of 2018, and its hepatitis C medicine Zepatier (elbasvir/grazoprevir) saw a more than 70% decline in sales from the same period in 2017. The introduction of Pifeltro and Delstrigo is crucial for stabilizing and potentially growing Merck's virology segment, although the impact is expected to be modest compared to other therapeutic areas like oncology and vaccines[1][2].

Competitive Landscape

The global HIV market is highly competitive, with major players like ViiV Healthcare and Gilead Sciences dominating the landscape. Pifeltro and Delstrigo will need to compete with established treatments and new therapies entering the market. The combination HIV medicines segment, which includes fixed-dose combinations like Delstrigo, is expected to lead the market growth during the forecast period[4].

Distribution and Sales Channels

Hospital pharmacies are projected to hold the dominant share in the distribution of HIV drugs, including Pifeltro, due to the rising patient visits to hospitals for HIV treatment. This segment is expected to support the growth of prescribed antiretroviral drugs like Pifeltro[4].

Regional Market Dynamics

North America, particularly the U.S., is a significant market for HIV drugs, driven by a high patient population and awareness about HIV/AIDS. The Asia Pacific region is anticipated to be the fastest-growing market, fueled by highly populated countries like China and India, along with increasing treatment programs and funding from the private sector[4].

Financial Performance of Merck

In the broader context of Merck's financial performance, the company has seen mixed results. In the third quarter of 2024, Merck reported total worldwide sales of $16.7 billion, a 4% increase from the same period in 2023. However, the pharmaceutical segment, which includes Pifeltro, saw a 5% increase driven by growth in oncology and cardiovascular, partially offset by declines in diabetes, vaccines, and virology[2].

Key Takeaways

• Market Approval: Pifeltro received FDA approval in 2018 based on Phase 3 clinical trials.
• Financial Projections: Expected to generate around $500 million in combined sales with Delstrigo by 2023.
• Market Challenges: Faces competition from established treatments and concerns about resistance.
• Impact on Merck: Crucial for stabilizing Merck's virology business but with modest expected impact.
• Distribution: Hospital pharmacies will be a key distribution channel.
• Regional Dynamics: North America and Asia Pacific are significant markets with different growth drivers.

FAQs

Q1: What is Pifeltro, and how is it used? Pifeltro, branded as doravirine, is an oral medication approved for the treatment of HIV-1 in adult patients who have never received antiretroviral treatment. It is taken once-daily with or without food.

Q2: What were the key findings from the clinical trials for Pifeltro? The Phase 3 DRIVE-AHEAD and DRIVE-FORWARD studies showed that Pifeltro demonstrated non-inferiority to other established HIV treatments. However, some participants showed the emergence of doravirine-associated resistance substitutions.

Q3: How does Pifeltro fit into Merck's overall business strategy? Pifeltro is part of Merck's efforts to bolster its virology business, which has faced challenges in recent years. It is expected to contribute to stabilizing and potentially growing this segment.

Q4: What are the financial projections for Pifeltro? Market research firm GlobalData predicts that Pifeltro and Delstrigo will generate around $500 million in combined sales across the seven major pharmaceutical markets by 2023.

Q5: How competitive is the market for HIV drugs, and where does Pifeltro stand? The global HIV market is highly competitive, dominated by players like ViiV Healthcare and Gilead Sciences. Pifeltro will need to compete with established treatments and new therapies, although it is expected to be well-received by physicians.

Sources

1. Biopharma Dive: Merck's virology business needs a boost. It may not get that from 2 new HIV drugs.
2. Merck: Merck Announces Third-Quarter 2024 Financial Results.
3. Merck: Merck Announces Third-Quarter 2020 Financial Results.
4. Fortune Business Insights: HIV Drugs Market Size & Growth | Global Report [2024-2032].
5. Merck: Merck Announces First-Quarter 2024 Financial Results.

Last updated: 2024-12-17