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DELSTRIGO Drug Patent Profile

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

Delstrigo is a drug marketed by Msd Merck Co and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. One supplier is listed for this compound. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Delstrigo

Delstrigo 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 October 7, 2031. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for DELSTRIGO

International Patents:	97
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Drug Prices:	Drug price information for DELSTRIGO
What excipients (inactive ingredients) are in DELSTRIGO?	DELSTRIGO excipients list
DailyMed Link:	DELSTRIGO at DailyMed

See drug prices for DELSTRIGO

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

Constraining patent/regulatory exclusivity:

8,486,975

NDA:

210807

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 DELSTRIGO

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

Sponsor	Phase
Africa Health Research Institute	Phase 3
Liverpool School of Tropical Medicine	Phase 4
Desmond Tutu Health Foundation	Phase 4

See all DELSTRIGO clinical trials

Pharmacology for DELSTRIGO

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

Paragraph IV (Patent) Challenges for DELSTRIGO

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 DELSTRIGO

DELSTRIGO is protected by five 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	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	8,486,975		Y	Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	10,603,282		Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	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	10,842,751		Y

International Patents for DELSTRIGO

When does loss-of-exclusivity occur for DELSTRIGO?

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 DELSTRIGO around the world.

Country	Patent Number	Title	Estimated Expiration
Nicaragua	201200146	INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
European Patent Office	4424373	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE LA DORAVIRINE, DU FUMARATE DE TÉNOFOVIR DISOPROXIL ET DE LAMIVUDINE (PHARMACEUTICAL COMPOSITIONS CONTAINING DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE)
Slovenia	2552902
Hungary	E031785
Spain	2536295

Supplementary Protection Certificates for DELSTRIGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
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	19C1024	France		PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1333 20181126

DELSTRIGO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Delstrigo

Introduction to Delstrigo

Delstrigo, a once-daily fixed-dose combination tablet, is a significant addition to the HIV-1 treatment landscape. Developed by Merck & Co., it combines doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF). This medication was approved by the FDA in 2018 for adult HIV-1 patients who have never received antiretroviral treatment[1][4].

Market Context

The HIV-1 drug market is highly competitive and crowded. The approval of Delstrigo and its companion drug, Pifeltro, marked a new entrant in this space, posing both opportunities and challenges for Merck.

• Competitive Landscape: The global HIV market is dominated by established players like Gilead Sciences, with drugs such as Atripla. Delstrigo's approval heightens competition, particularly as it targets treatment-naïve patients[1][4].
• Patient Needs: Delstrigo offers a compelling clinical profile, including a lower incidence of neuropsychiatric adverse events and superior lipid profiles compared to other treatments like efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)[4].

Clinical Profile and Advantages

Delstrigo's clinical profile is a key factor in its market positioning.

• Efficacy: Delstrigo showed non-inferiority to Atripla in the Phase 3 DRIVE-AHEAD study. This efficacy, combined with its once-daily dosing, makes it an attractive option for patients and clinicians[1][4].
• Safety: The drug demonstrated a statistically significant lower proportion of neuropsychiatric adverse events and better lipid profiles, which are crucial for long-term patient health[4].

Financial Projections

The financial trajectory of Delstrigo is closely tied to its market performance and the overall dynamics of the pharmaceutical industry.

• Sales Projections: Market research firm GlobalData predicts that Delstrigo and Pifeltro will generate around $500 million combined across the seven major pharmaceutical markets by 2023. This is a significant but modest contribution compared to the sales of more established HIV treatments[1].
• Pricing Strategy: Delstrigo is priced at $70 per day, which is competitive within the HIV treatment market. However, pricing strategies can be influenced by various factors, including government programs, insurance coverage, and competition[4].

Challenges and Risks

Despite its potential, Delstrigo faces several challenges that could impact its financial trajectory.

• Resistance Concerns: Clinical trials showed the emergence of doravirine-associated resistance substitutions in some patients. This could affect the drug's long-term efficacy and market acceptance[1].
• Market Saturation: The HIV market is crowded, and new entrants must compete with well-established brands. This competition can limit market share and revenue growth[1][4].

Merck's Virology Business

Delstrigo's performance is also tied to the overall health of Merck's virology business.

• Current State: Merck's virology business has been struggling, with flat sales of its HIV drug Isentress and a significant decline in sales of its hepatitis C medicine Zepatier. New products like Delstrigo are crucial for reviving this segment[1].
• Future Outlook: While Delstrigo and Pifeltro are expected to contribute positively, they may not fully offset the decline in other virology products. Merck's overall strategy, including partnerships and new product pipelines, will be critical in stabilizing and growing its virology business[1].

Access and Affordability

Ensuring access to Delstrigo is vital for its success.

• Government and Commercial Programs: Merck is working to secure access for patients through commercial and government-sponsored programs, including Medicare Part D, Medicaid, and AIDS Drug Assistance Programs[4].
• Affordability: The high daily cost of $70 can be a barrier for some patients. Merck's efforts to negotiate with payers and secure favorable formulary placements will be essential in making the drug more accessible[4].

Economic Implications

The development and pricing of Delstrigo reflect broader trends in the pharmaceutical industry.

• Precision Medicines: The shift towards precision medicines, like Delstrigo, has economic implications, including changes in pricing policies and the structure of government incentives. These medicines often target smaller patient populations, which can affect generic competition and pricing strategies[3].
• Innovation and R&D: The investment in R&D for drugs like Delstrigo is significant. The economic success of these drugs can influence future R&D priorities and the overall innovation landscape in the pharmaceutical sector[3].

Key Takeaways

• Delstrigo offers a compelling clinical profile with advantages in safety and efficacy.
• Market competition is high, with established players dominating the HIV-1 treatment market.
• Financial projections are modest but significant, with predicted combined sales of $500 million by 2023.
• Challenges include resistance concerns and market saturation.
• Access and affordability are critical for the drug's success.
• Broader economic implications include the impact on pricing policies and R&D priorities.

FAQs

1. What is Delstrigo, and how is it used?

   • Delstrigo is a once-daily fixed-dose combination tablet containing doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF), used for treating HIV-1 in adult patients who have never received antiretroviral treatment.

2. How does Delstrigo compare to other HIV treatments?

   • Delstrigo has shown non-inferiority to Atripla and has a better safety profile in terms of neuropsychiatric adverse events and lipid profiles.

3. What are the financial projections for Delstrigo?

   • GlobalData predicts that Delstrigo and Pifeltro will generate around $500 million combined across major pharmaceutical markets by 2023.

4. What challenges does Delstrigo face in the market?

   • Delstrigo faces challenges such as resistance concerns, market saturation, and competition from established brands.

5. How is Merck working to ensure access to Delstrigo?

   • Merck is working to secure access through commercial and government-sponsored programs, including Medicare Part D, Medicaid, and AIDS Drug Assistance Programs.

Cited Sources

1. Biopharma Dive - "Merck's virology business needs a boost. It may not get that from 2 new HIV drugs"[1]
2. Merck & Co., Inc. Financial Highlights Package - First Quarter 2024[2]
3. National Bureau of Economic Research - "The Economics of Drug Development: Pricing and Innovation in a Changing Market"[3]
4. Managed Healthcare Executive - "New HIV-1 treatments join crowded market"[4]