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 one hundred and one patent family members in forty-six 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 August 30, 2032. 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:	101
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

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 DELSTRIGO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018535991	ドラビリン、テノホビルジソプロキシルフマル酸塩およびラミブジンを含有する医薬組成物
Hungary	E056978
Denmark	2924034
Croatia	P20211687
Lithuania	C2552902
Spain	2895951
Chile	2012002744

Supplementary Protection Certificates for DELSTRIGO

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 DELSTRIGO: An In-Depth Analysis

Last updated: July 28, 2025

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Introduction

DELSTRIGO, a once-promising combination antiretroviral therapy (ART), has garnered significant attention within the global HIV treatment landscape. Developed by MSD (Merck & Co.) and Pfizer, DELSTRIGO combines doravirine, lamivudine, and tenofovir disoproxil fumarate, targeting the management of HIV-1 infections. As the pharmaceutical industry pivots towards innovative therapies and personalized medicine, understanding DELSTRIGO's market dynamics and financial trajectory offers vital insights into its commercial viability amid evolving competitive and regulatory environments.

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Market Landscape and Growth Drivers

Global HIV Treatment Market

The global HIV/AIDS therapeutics market was valued at approximately USD 45 billion in 2022, with projections estimating CAGR growth of around 3-4% through 2030. A key driver is the increasing prevalence of HIV globally, notably in sub-Saharan Africa, Asia-Pacific, and emerging markets. The World Health Organization (WHO) reports over 38 million people living with HIV worldwide, emphasizing the ongoing therapeutic demand[1].

Product Positioning and Market Share

DELSTRIGO’s initial market positioning capitalized on its once-daily dosing, tolerability profile, and simplified regimen—attributes that appeal to both clinicians and patients. It directly competes with other fixed-dose combinations (FDCs), including Genvoya, Biktarvy, and Dovato, which continue to consolidate market share due to their demonstrated efficacy and safety (Tables 1 and 2). Despite this, DELSTRIGO's unique formulation offers a distinct niche, particularly for patients intolerant to alternative agents.

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Market Dynamics Influencing DELSTRIGO

Regulatory and Patent Landscape

The regulatory environment significantly impacts DELSTRIGO’s commercial trajectory. Its initial FDA approval in 2018 provided a 5-year period of market exclusivity, with patent protections, including formulation patents, expiring between 2023-2025. The expiration opens pathways for generic competition, exerting downward pressure on pricing and market share[2].

Competitive Pressures and Formulation Advances

Emerging therapies, notably agents with improved safety profiles and fewer side effects, favor newer classes such as integrase inhibitor-based regimens. For example, bictegravir-based therapies have gained prominence, limiting DELSTRIGO’s relative market share. Additionally, behavioral shifts favoring once-daily, low-pill burden regimens continue to advantage newer agents.

Pricing Strategies and Reimbursement

High-cost therapies like DELSTRIGO face reimbursement challenges globally, with price sensitivity dominating decision-making in many regions. Manufacturers have employed tiered pricing, discounts, and value-based contracts to sustain sales. However, escalating healthcare costs and the push for generic alternatives threaten profit margins[3].

Market Penetration and Patient Adoption

Despite robust clinical data, DELSTRIGO’s adoption depends on physician familiarity, patient preference, and regional access. Limited geographic availability outside the U.S. and Europe hampers its global reach. Furthermore, the rise of integrase inhibitors as first-line therapies reduces physician reliance on older regimens like DELSTRIGO.

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Financial Trajectory Analysis

Historical Revenue Trends

Since its launch, DELSTRIGO generated peak revenues estimated at USD 500–600 million globally in 2019-2020. However, subsequent years have seen a plateau or modest decline, attributable to increased competition and patent expiration effects. According to publicly available financial disclosures, MSD reported a decline in its HIV franchise revenues consistent with these market trends[4].

Impact of Patent Expiry and Generic Entry

Patent expiry around 2023-2025 portends a sharp revenue decline, as generic formulations enter key markets. Similar to other HIV therapies, initial generic penetration is gradual but accelerates with regulatory approvals and market acceptance, potentially eroding 50-70% of peak revenues within the subsequent 2-3 years.

Pipeline and Lifecycle Management

MSD and Pfizer have continued investing in next-generation antiretroviral agents and fixed-dose combinations. The development of novel agents with improved profiles (e.g., islatravir-based regimens) aims to offset declining revenues from DELSTRIGO. Lifecycle management strategies include dosing modifications, expanded indications, and combination with novel drugs.

Revenue Forecasts (2023-2030)

Forecasting indicates a steep revenue decline post-2023, with revenues potentially dropping below USD 200 million by 2025. Recovery may occur if new formulations or indications are approved, but the overarching trend suggests a phased decline driven by generics and market saturation[5].

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Future Outlook and Strategic Considerations

Opportunities

• Market Expansion: Increasing access in emerging markets, where HIV prevalence is high but ART options are limited, presents a growth opportunity if regulatory and procurement barriers are managed.
• Line Extension and Combination Therapies: Developing flexible dosing, especially for pediatric or treatment-experienced populations, could extend product lifecycle.
• Partnerships: Collaborations with biosimilar developers and regional manufacturers could facilitate generic entry and mitigate revenue losses.

Risks

• Patent Litigation and Regulatory Challenges: Patent challenges or accelerated approvals for generics could precipitate early market entry.
• Therapeutic Paradigm Shift: The rapid shift towards integrase inhibitor-based regimens may marginalize older therapies like DELSTRIGO.
• Pricing Pressures: Public and private payers’ push for lower-cost generics could diminish margins.

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Conclusion

DELSTRIGO's market dynamics exemplify the challenges faced by established HIV therapies amid patent cliffs, fierce competition, and evolving treatment paradigms. Its initial success was driven by convenient dosing and tolerability, but the impending patent expirations and burgeoning pipeline threaten its financial trajectory. Strategic lifecycle management, geographic expansion, and pipeline evolution are vital for sustaining profitability. Ultimately, organizations must navigate patent landscapes, market preferences, and reimbursement policies to optimize returns on their investments.

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Key Takeaways

• Market decline is imminent post-patent expiry, with revenue reductions of up to 70% expected within 2-3 years after generic entry.
• Competitive pressures favor newer regimens, particularly integrase inhibitor-based therapies, diminishing DELSTRIGO's market share.
• Emerging markets could provide growth opportunities if barriers to access are addressed; however, pricing and regulatory hurdles remain.
• Pipeline development and lifecycle strategies are essential to offset revenue erosion and maintain a competitive edge.
• Strategic collaborations and geographic expansion are vital to prolong product relevance and profitability.

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FAQs

1. When is DELSTRIGO's patent set to expire, and how will it impact the market?
Patent protections are expiring around 2023-2025, opening the door for generic manufacturers. This transition is expected to cause significant revenue declines, intensifying price competition and reducing market share for the original formulation.

2. How does DELSTRIGO compare with its competitors in efficacy and safety?
Clinical trials indicate comparable efficacy to other first-line ARTs, with a favorable safety profile. However, newer agents like Biktarvy and Dovato offer simplified dosing and potentially fewer side effects, often influencing prescriber preference.

3. What strategies are manufacturers employing to sustain DELSTRIGO's sales?
Strategies include lifecycle extensions through new formulations, expanding geographic access, establishing generic licensing agreements, and investing in pipeline development of next-generation therapies.

4. What are the primary challenges facing DELSTRIGO’s continued market presence?
Key challenges include patent expirations, competitive displacement by newer therapies, pricing pressures, and limited access in emerging markets, all contributing to a shrinking revenue base.

5. What is the outlook for DELSTRIGO amidst ongoing innovations in HIV therapy?
While near-term revenues are expected to decline sharply, ongoing pipeline innovations and strategic market expansion may sustain its relevance. Long-term viability hinges on adaptation to the changing therapeutic landscape and regulatory environment.

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References

[1] WHO. Global HIV/AIDS Fact Sheet 2022.
[2] U.S. Patent and Trademark Office. Patent expiration timelines.
[3] IMS Health. Global HIV Treatment Pricing Report, 2022.
[4] MSD Financial Reports, 2019-2022.
[5] MarketResearch.com. HIV Therapeutics Market Forecasts, 2023-2030.