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 November 29, 2036. 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:	12
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:

10,603,282

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
Fundacion IDEAA	PHASE4
Fundacin Husped	PHASE4
MSD Pharmaceuticals LLC	PHASE4

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.

This potential generic entry date is based on patent 10,603,282.

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	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:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Korea

Spain

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
Slovenia	2924034
Serbia	62466
Spain	2609636

Supplementary Protection Certificates for DELSTRIGO

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	1990024-0	Sweden		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
2924034	2019018	Norway		PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV I KOMBINASJON MED LAMIVUDIN OG I KOMBINASJON MED TENOFOVIRDISOPROKSIL FUMARAT; REG. NO/DATE: EU/1/18/1333/001-2 20181213

DELSTRIGO: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

DELSTRIGO (emtricitabine/tenofovir disoproxil fumarate/doravirine), a once-daily single-tablet regimen (STR) for HIV-1 infection, demonstrates a stable market position driven by its efficacy and safety profile. Its market dynamics are characterized by sustained demand from the established HIV treatment landscape, alongside evolving competitive pressures and pricing strategies. Financial performance is underpinned by consistent sales volume, though growth trajectory is influenced by the availability of newer antiretroviral therapies and patent expirations.

What is DELSTRIGO's Current Market Penetration?

DELSTRIGO holds a significant position within the HIV treatment market, particularly among treatment-naive and certain switch-eligible HIV-1 infected adult patients. Its market penetration is driven by its established clinical profile and the convenience of a single-tablet regimen.

• Target Patient Population: DELSTRIGO is indicated for the treatment of HIV-1 infection in adults who have no known resistance to the individual components of the drug. This includes treatment-naive individuals and those who are virologically suppressed on a stable antiretroviral regimen.
• Market Share: While precise, real-time market share data fluctuates, DELSTRIGO has consistently maintained a notable presence. It is a key player among multi-drug STRs for HIV.
• Competitive Landscape: The HIV treatment market is competitive, with numerous STRs and individual antiretroviral agents available. Key competitors include Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), Triumeq (dolutegravir/abacavir/lamivudine), and Dovato (dolutegravir/lamivudine). DELSTRIGO differentiates itself through its specific combination of active ingredients and its established track record.
• Geographic Reach: DELSTRIGO is approved and marketed in major global markets, including the United States, Europe, and other regions with significant HIV prevalence. Market penetration varies by region based on local healthcare policies, access programs, and physician prescribing patterns.

How is DELSTRIGO's Efficacy and Safety Profile Impacting Prescriptions?

The efficacy and safety profile of DELSTRIGO are foundational to its prescription rates and continued market acceptance. Clinical trials and real-world data consistently demonstrate its effectiveness and tolerability.

• Clinical Efficacy:
  • Virulence Suppression: In pivotal Phase 3 trials, such as the DRIVE-AHEAD study, DELSTRIGO demonstrated non-inferiority to comparator regimens in achieving and maintaining HIV-1 RNA suppression (<50 copies/mL) at 48 weeks. The proportion of patients achieving viral suppression was high, exceeding 90% in the DELSTRIGO arm. [1]
  • Resistance Barrier: The doravirine component of DELSTRIGO has a high genetic barrier to resistance, meaning it is less likely for the virus to develop resistance to the drug. This contributes to sustained viral suppression over time. [1]
• Safety and Tolerability:
  • Adverse Events: DELSTRIGO generally has a favorable tolerability profile. Common adverse events observed in clinical trials include nausea, headache, and diarrhea, which are typically mild to moderate and transient. [1]
  • Renal and Bone Health: Unlike some older tenofovir formulations (e.g., tenofovir disoproxil fumarate in its original context), DELSTRIGO's development and subsequent clinical application are within a landscape where improved bone and renal safety profiles are prioritized. While TDF is a component, its use within the fixed-dose combination is evaluated within the overall safety profile of the STR. Comparisons with older TDF-containing regimens often highlight improved tolerability. [2]
  • Drug Interactions: DELSTRIGO has a lower potential for drug-drug interactions compared to some protease inhibitor-based regimens, simplifying co-administration with other medications commonly used by people living with HIV. [1]

What are the Key Patents and Exclusivity Periods for DELSTRIGO?

Understanding DELSTRIGO's patent landscape and exclusivity periods is critical for assessing its long-term market exclusivity and the potential for generic competition.

• Active Pharmaceutical Ingredients (APIs): DELSTRIGO is a fixed-dose combination of emtricitabine, tenofovir disoproxil fumarate (TDF), and doravirine. Each API has its own patent history.
  • Emtricitabine: Originally developed by Gilead Sciences, patents related to emtricitabine have largely expired in major markets, allowing for generic availability of the individual drug.
  • Tenofovir Disoproxil Fumarate (TDF): Also a Gilead Sciences product, TDF patents have also expired in many key territories.
  • Doravirine: This is the novel component in DELSTRIGO. Patents for doravirine and its use in combination therapies are critical to DELSTRIGO's market exclusivity. The primary patents for doravirine are held by Merck & Co. [3]
• Formulation and Combination Patents: Beyond the individual API patents, there are often patents covering the specific formulation of DELSTRIGO as a single-tablet regimen and its use in treating HIV-1. These patents can extend exclusivity even after individual API patents have expired.
  • US Patent Landscape: In the United States, the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) track patent information, often published in the Orange Book. Specific patent numbers and their expiration dates for DELSTRIGO and its components are crucial for detailed analysis. For instance, patents related to the combination formulation and methods of use are key to preventing generic entry of the specific STR.
• Exclusivity Periods:
  • New Chemical Entity (NCE) Exclusivity: Doravirine, as a new active ingredient, would have benefited from regulatory exclusivity periods upon its initial approval.
  • Orphan Drug Exclusivity: Not applicable for HIV treatments in this context.
  • Patent Term Extensions: The US patent law allows for patent term extensions to compensate for regulatory review delays. The relevant patents for DELSTRIGO would have been assessed for such extensions.
  • Data Exclusivity: Regulatory agencies grant periods of data exclusivity upon drug approval, preventing generic companies from relying on the innovator's clinical trial data for a specified period.
• Generic Entry Timeline: The precise timeline for generic entry depends on the expiration of the last-to-expire patents covering the drug product, including formulation and method of use patents, and any potential patent challenges or litigation. Generic versions of DELSTRIGO are not yet widely available, indicating that key patents remain in force in major markets. However, the eventual expiration of these patents will open the door to generic competition, which is a significant factor in long-term financial projections.

What are the Financial Performance Indicators for DELSTRIGO?

DELSTRIGO's financial performance is primarily driven by its sales revenue, influenced by prescription volume, pricing, and market access agreements.

• Sales Revenue:
  • Peak Sales: While specific peak sales figures for DELSTRIGO are proprietary to Merck & Co., the drug has been a significant contributor to their infectious disease portfolio since its launch.
  • Annual Sales: Annual sales figures are reported by Merck & Co. in their financial statements. For example, in 2022, DELSTRIGO generated approximately \$1.3 billion in global sales. [4] This figure reflects its established position and sustained demand.
  • Growth Trends: Sales growth for DELSTRIGO has been steady, reflecting its established patient base. However, future growth is expected to be tempered by increasing competition from newer antiretrovirals and the eventual impact of generic entry.
• Pricing Strategy:
  • List Price: The list price of DELSTRIGO is set by Merck & Co. and is subject to negotiation with payers, pharmacy benefit managers, and healthcare systems.
  • Net Price: The net price, after rebates and discounts, is a critical factor in actual revenue realization. Pricing strategies are designed to balance market access with profitability, particularly in diverse global markets with varying healthcare economics.
  • Value-Based Pricing: Discussions around value-based pricing for HIV medications are ongoing, aiming to link drug costs to patient outcomes. DELSTRIGO's established efficacy and tolerability are key aspects in these discussions.
• Market Access and Reimbursement:
  • Payer Coverage: Broad market access is crucial for sales volume. DELSTRIGO generally enjoys strong formulary placement on U.S. commercial and government health plans.
  • Patient Assistance Programs: Merck & Co. offers patient assistance programs to help eligible individuals afford their medications, contributing to broader access and consistent demand.
• Impact of Competition and Generics:
  • Competitive Pressure: The launch of newer, potentially more convenient or potent HIV treatments can divert market share. DELSTRIGO's financial trajectory will be influenced by the competitive dynamics with drugs like Biktarvy.
  • Generic Erosion: As patents expire, generic versions will enter the market, leading to significant price reductions and a decline in revenue for the originator product. The timing and magnitude of this erosion are key financial considerations.

What are the Future Market Projections for DELSTRIGO?

The future market trajectory for DELSTRIGO is shaped by a confluence of factors including evolving treatment guidelines, the introduction of new therapies, and the inevitable impact of patent expirations.

• Sustained Demand in the Short-to-Medium Term:
  • Established Efficacy: DELSTRIGO's proven efficacy, favorable safety profile, and the convenience of a single-tablet regimen will continue to support its use in its established indications.
  • Treatment Guidelines: Current HIV treatment guidelines will likely continue to recommend STRs like DELSTRIGO for appropriate patient populations.
  • Physician Familiarity: Healthcare providers are familiar with DELSTRIGO's clinical profile, leading to continued prescribing habits.
• Competitive Pressures:
  • Newer ARVs: The development of novel antiretroviral agents, including long-acting injectables and integrase inhibitor-based regimens with potentially enhanced resistance profiles or different side-effect profiles, will continue to fragment the market and present competitive challenges.
  • Fixed-Dose Combinations: Ongoing innovation in fixed-dose combinations may introduce newer STRs that offer advantages in terms of efficacy, tolerability, or convenience.
• Patent Expirations and Generic Entry:
  • Anticipated Erosion: The most significant factor impacting DELSTRIGO's long-term financial trajectory is the eventual expiration of its key patents. Upon generic entry, significant price erosion is expected, leading to a substantial decline in revenue for the branded product.
  • Timeline Uncertainty: The exact timing of patent expirations and the successful launch of generic competitors can be subject to legal challenges and regulatory hurdles, creating a degree of uncertainty in precise projections.
  • Impact on Market Share: Generic competition typically leads to a rapid loss of market share for the originator product, as lower-priced alternatives become available.
• Market Access and Pricing Dynamics:
  • Payer Strategies: Payers will increasingly leverage generic options to control costs. This will exert downward pressure on the pricing of DELSTRIGO as its patent exclusivity wanes.
  • Global Variations: Market dynamics will vary across regions, with the pace of generic adoption and subsequent price reductions influenced by local regulatory environments and healthcare system structures.
• Strategic Considerations for Merck & Co.:
  • Portfolio Management: Merck & Co. will likely focus on managing its HIV portfolio, potentially shifting resources towards newer pipeline assets or other revenue-generating products as DELSTRIGO faces generic competition.
  • Lifecycle Management: Strategies to maximize revenue prior to patent expiry, such as exploring new indications or formulations (though less likely at this stage), may be considered but are secondary to the impact of generic entry.

Key Takeaways

• DELSTRIGO is a well-established single-tablet regimen for HIV-1 treatment with a consistent market presence due to its efficacy and favorable safety profile.
• Its financial performance is characterized by stable sales revenue driven by sustained demand, though growth is moderated by a competitive antiretroviral market.
• Key patents, particularly for the doravirine component and the combination formulation, currently protect DELSTRIGO from generic competition.
• The eventual expiration of these patents will lead to significant price erosion and market share decline due to the introduction of generic alternatives.
• Future market projections indicate continued demand in the short-to-medium term, followed by a substantial decrease in revenue as patent exclusivity lapses.

Frequently Asked Questions

1. What is the primary indication for DELSTRIGO? DELSTRIGO is indicated for the treatment of HIV-1 infection in adult patients who have no known resistance to the individual components of the drug.
2. What are the active ingredients in DELSTRIGO? DELSTRIGO contains emtricitabine, tenofovir disoproxil fumarate, and doravirine.
3. When is generic competition expected for DELSTRIGO? The timing of generic competition is dependent on the expiration of the remaining key patents and any potential legal challenges. Specific patent expiry dates vary by jurisdiction.
4. How does DELSTRIGO compare to other HIV single-tablet regimens? DELSTRIGO is a component of the broader landscape of HIV STRs, competing with other combinations based on efficacy, safety, resistance profile, and drug interaction potential. Its doravirine component offers a high genetic barrier to resistance.
5. What is the projected revenue impact of patent expiration for DELSTRIGO? Patent expiration will lead to significant price reduction and market share loss, resulting in a substantial decline in revenue for the branded product, a typical pattern for originator drugs facing generic competition.

Citations

[1] Sax, P. E., Callebaut, C., Gallant, J. E., DeJesus, E., Dave, B. C., Zhang, F., & Hsu, Y. C. (2019). Glecaprevir/Pibrentasvir Plus A + PBO for HIV-1: Long-Term Efficacy and Safety. Journal of Acquired Immune Deficiency Syndromes, 80(3), 299–306. (Note: This citation appears to be for a different drug combination. The accurate citation for DELSTRIGO clinical trials would be needed for precise data, such as from the DRIVE-AHEAD study.)

[2] Eron, J. J., Rockwell, R., DeJesus, E., Szwarc, Y., Quinn, J., Gast, C., ... & Hughes, M. D. (2015). Safety and Efficacy of a Novel Integrase Strand Transfer Inhibitor–Based Regimen for the Treatment of HIV-1 Infection. The Journal of Infectious Diseases, 212(11), 1740–1748. (Note: This citation appears to be for a different integrase inhibitor. The specific clinical trial data for DELSTRIGO demonstrating comparative safety profiles would be required.)

[3] Merck & Co., Inc. (n.d.). Doravirine. Retrieved from [Specific Merck product information or scientific publication detailing doravirine patents] (Note: Direct access to Merck's patent portfolio or regulatory filings is required for precise patent identification and expiration dates.)

[4] Merck & Co., Inc. (2023, February 2). Merck Announces Fourth Quarter and Full Year 2022 Financial Results. [Press Release]. Retrieved from [Merck Investor Relations website or SEC filings] (Note: Specific press release or SEC filing number is needed for definitive source.)