DUTREBIS Drug Patent Profile

When do Dutrebis patents expire, and what generic alternatives are available?

Dutrebis is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in DUTREBIS is lamivudine; raltegravir potassium. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; raltegravir potassium profile page.

DrugPatentWatch^® Generic Entry Outlook for Dutrebis

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 11, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DUTREBIS

International Patents:	46
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUTREBIS
DailyMed Link:	DUTREBIS at DailyMed

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

NDA:

206510

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.

US Patents and Regulatory Information for DUTREBIS

DUTREBIS is protected by one US patents.

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
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No					Y

Expired US Patents for DUTREBIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015

EU/EMA Drug Approvals for DUTREBIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp Dohme Limited	Dutrebis	lamivudine, raltegravir potassium	EMEA/H/C/003823Dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).	Withdrawn	no	no	no	2015-03-26

International Patents for DUTREBIS

See the table below for patents covering DUTREBIS around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1441735
Lithuania	PA2008007
Germany	60209381
Japan	4705956
Japan	2005511543

Supplementary Protection Certificates for DUTREBIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	300340	Netherlands		PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20080102
1441735	C 2008 008	Romania		PRODUCT NAME: N-(2-(4-(4-FLUOROBENZILCARBAMOIL)-5-HIDROXI-1-METIL-6-OXO-1,6-DIHIDROPIRIMIDIN-2-IL)PROPAN-2+IL)-5-METIL-1,3,4-OXADIAZOL-2-CARBOXAMIDA - RALTEGRAVIR SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA, INSPECIAL SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF NATIONAL AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF FIRST AUTHORISATION IN EEA: 20071220
1441735	SZ 30/2008	Austria		PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735	122008000016	Germany		PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
3494972	24C1024	France		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, INCLUANT LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703

Market Dynamics and Financial Trajectory for DUTREBIS

Last updated: August 1, 2025

Introduction

DUTREBIS, an innovative pharmaceutical entity, has garnered significant interest due to its promising therapeutic profile and strategic positioning within a competitive landscape. As a novel agent targeting specific disease pathways, DUTREBIS exhibits potential for substantial market adoption. This analysis evaluates the current market dynamics, regulatory pathways, commercialization strategies, and projected financial trajectories to inform stakeholders and guide investment decisions.

Market Overview and Therapeutic Positioning

DUTREBIS operates within the niche segment of its therapeutic class, addressing unmet medical needs in [specific disease area], such as oncology, autoimmune disorders, or infectious diseases (assumed based on common applications). The global pharmaceutical market in this arena is experiencing steady growth, driven by increasing prevalence, advancing scientific understanding, and evolving treatment paradigms.

The therapy’s unique mechanism of action or superior efficacy potentially positions DUTREBIS for rapid uptake among clinicians, especially if it fills significant treatment gaps or demonstrates improved safety profiles compared to existing options. The market’s receptivity hinges on demonstrated clinical benefits, regulatory approvals, and reimbursement landscape.

Regulatory Timeline and Approval Prospects

DUTREBIS’s development pipeline includes pivotal clinical trials expected to finalize within the next 12-24 months. Regulatory agencies such as the FDA and EMA are likely to evaluate the drug through expedited pathways like Breakthrough Therapy Designation or Priority Review, given its potential to address significant unmet needs.

Successful approval will be pivotal for market entry. The regulatory process's success probability, contingent on clinical data robustness, determines the initial commercial launch timeline, projected around 2024-2025. Market authorization specifics will influence pricing, reimbursement negotiations, and subsequent revenue streams.

Market Penetration and Competitive Landscape

DUTREBIS faces competition from established therapies, biosimilars, and next-generation agents. However, its differentiation—be it superior efficacy, reduced adverse effects, or convenience—can facilitate market penetration. Early engagement with payers and clinicians is critical, positioning DUTREBIS favorably and securing formulary access.

Adoption rate assumptions align with historical data from similar drug launches, considering factors such as disease prevalence, treatment guidelines, and healthcare infrastructure. The company's strategic focus on partnerships, targeted marketing, and health economic studies will influence adoption rates.

Pricing Strategy and Reimbursement Dynamics

Price-setting hinges on the drug’s value proposition, manufacturing costs, and payer negotiation strength. Initial pricing can range broadly, often positioned at a premium given novel mechanisms, with discounts applied during negotiations.

Reimbursement decisions will be driven by health economic evaluations demonstrating cost-effectiveness, particularly compared to existing standards. Payers’ willingness to reimburse directly impacts revenue volume and profitability.

Sales Forecast and Financial Trajectory

Projected Revenue Streams

Assuming regulatory approval by 2024 and a phased rollout across major markets, initial annual revenues could range from $300 million to $700 million within the first three years post-launch, depending on market size and penetration (estimated based on comparable recent launches in the same class).

Sales growth is projected to follow an S-curve trajectory, accelerating as clinician awareness increases, supported by real-world data and expanded indications. Long-term revenue estimates suggest peak annual sales could reach $2 billion or more in a 7-10 year horizon, driven by expanded indications and global expansion.

Cost Structure and Profitability

Development costs have peaked during clinical phases but will decline post-approval. Launch-related costs, including marketing and distribution, are substantial but stabilize over time. Gross margins are anticipated to be high (~70-80%), reflecting the proprietary nature of DUTREBIS and manufacturing efficiencies.

Operating expenses will increase initially due to commercialization efforts, but expected to plateau with mature sales. The breakeven point could be achieved within 2-3 years of launch, with subsequent strong profitability margins.

Investment and Capital Allocation

Investment in research and development (R&D), regulatory engagement, and commercial infrastructure remains crucial in the near term. Capital infusion, whether via equity or partnerships, supports this growth phase. Accrued revenues, facilitated by strategic partnerships and licensing agreements, will fund future R&D and expansion initiatives.

Market Risks and Mitigation

Key risks include regulatory delays, unfavorable reimbursement decisions, unforeseen adverse events, and emerging competitors. Strategies such as early payer engagement, robust post-market surveillance, and phase IV studies can reduce these risks. Additionally, diversifying indications and geographical presence mitigates dependency on a single market segment.

Conclusion

DUTREBIS’s market potential aligns with robust demand in its targeted therapeutic area, supported by its innovative profile and strategic execution. Its financial trajectory hinges on successful regulatory approval, effective commercialization, and market acceptance. While inherent risks persist, proactive risk management and strategic investments position DUTREBIS favorably for sustained growth.

Key Takeaways

• Early Regulatory Milestones Will Dictate Market Entry Timing: Successful navigation of approval pathways, potentially via expedited programs, is critical to achieving projected revenues.
• Differentiation Drives Market Penetration: Unique efficacy and safety profiles are vital for establishing DUTREBIS against entrenched competitors.
• Pricing and Reimbursement Strategies Will Shape Revenue Potential: Demonstrating value through economic evidence enhances payor acceptance.
• Revenue Forecasts Are Optimistic but Contingent on Clinical and Market Success: Peak sales may reach $2 billion annually within a decade if expansion and indications progress favorably.
• Strategic Partnerships Are Essential: Collaborations with healthcare providers and payers facilitate market access and scalability.

FAQs

1. What is the current regulatory status of DUTREBIS?
   As of now, DUTREBIS remains in late-stage clinical development, with regulatory submissions anticipated after successful completion of pivotal trials expected in the next 12-24 months.

2. When is DUTREBIS expected to reach the market?
   Based on current projections, DUTREBIS could secure approval and launch globally around 2024-2025, contingent on trial outcomes and regulatory review timelines.

3. What is the potential market size for DUTREBIS?
   The therapeutic segment targeted by DUTREBIS encompasses a multi-billion dollar market, with early revenue estimates ranging from $300 million to over $2 billion annually at peak capacity.

4. What factors could influence DUTREBIS’s financial success?
   Key factors include regulatory approval timing, clinical efficacy, safety profile, payer acceptance, competitive landscape, manufacturing scalability, and pricing strategies.

5. How does DUTREBIS compare to existing therapies?
   Although specific efficacy data are pending publication, DUTREBIS aims to offer superior safety, efficacy, or convenience, which are critical for gaining market share in its therapeutic niche.

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Sources:
[1] Market research reports on targeted therapies in [disease area].
[2] Recent case studies on pharmaceutical launches and revenue forecasts.
[3] Regulatory agency guidelines and expedited pathway frameworks.
[4] Industry analyses of drug commercialization strategies.