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 are two patents protecting this drug.

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

Indicators of Generic Entry

Summary for DUTREBIS

International Patents:	95
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	21
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 two 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
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No

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/003823 Dutrebis 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
Canada	2463976	INHIBITEURS DE L'INTEGRASE DU VIH A BASE D'HYDROXYPYRIMIDINONE CARBOXAMIDE N-SUBSTITUE (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE)
Eurasian Patent Organization	200400585
Taiwan	200631944	Potassium salt of an HIV integrase inhibitor
New Zealand	533057	N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase

Supplementary Protection Certificates for DUTREBIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	C01441735/01	Switzerland		FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
1441735	DO 67; 3-2008	Slovakia		PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
3494972	LUC00346	Luxembourg		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703

DUTREBIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of DUTREBIS in the HIV-1 Treatment Market

Introduction to DUTREBIS

DUTREBIS, a fixed-dose combination (FDC) of lamivudine and rilpivirine, is used in the treatment of HIV-1 infection. To understand its market dynamics and financial trajectory, it is crucial to analyze the broader trends in the HIV-1 treatment market.

HIV-1 Treatment Market Overview

The HIV-1 treatment market has undergone significant changes in recent years, driven by advancements in antiretroviral therapies (ART) and shifting patient and physician preferences.

Shift from Multi-Tablet Regimens (MTRs) to Single-Tablet Regimens (STRs)

There has been a notable shift from MTRs to STRs due to the convenience, improved patient compliance, and reduced pill burden associated with STRs. For instance, the US market for MTRs declined from $5,918 million in 2018 to $3,867 million in 2020, while the market for STRs increased from $10,305 million in 2018 to $13,620 million in 2020[1].

Tenofovir Disoproxil Fumarate (TDF) vs. Tenofovir Alafenamide (TAF) Based Regimens

The market is also transitioning from TDF-based regimens to TAF-based regimens due to the latter's improved safety profile and reduced bone and kidney toxicity. This shift has impacted the sales of various HIV-1 therapies, including those that contain DUTREBIS's components.

Impact on DUTREBIS

DUTREBIS, being a combination of lamivudine and rilpivirine, faces competition from newer and more preferred STRs like Biktarvy (bictegravir, emtricitabine, and TAF) and other TAF-based regimens. Biktarvy, approved in 2018, has shown excellent safety and efficacy and does not require pharmacokinetic boosting, making it a market leader with sales increasing from $1,144 million in 2018 to $6,095 million in 2020[1].

Patent Expiry and Generic Competition

The HIV-1 treatment market is also influenced by patent expiries and the subsequent entry of generic drugs. Several key HIV-1 drugs, including those in the same class as DUTREBIS, are set to lose their patent protection between 2025 and 2030. For example, patents for drugs like Selzentry, Atripla, Truvada, and Complera/Eviplera are expiring, which could lead to increased generic competition and reduced pricing power for branded drugs[1][2].

Financial Trajectory

Given the competitive landscape and market trends, the financial trajectory of DUTREBIS is likely to be challenging.

Declining Market Share

As newer and more preferred STRs gain market share, DUTREBIS is expected to see a decline in its market share. The preference for TAF-based regimens and the rise of Biktarvy have already led to a decline in sales for other HIV-1 therapies, including those similar to DUTREBIS[1].

Pricing Pressure

The entry of generics and the loss of patent exclusivity for several HIV-1 drugs will increase pricing pressure. This could further reduce the revenue generated by DUTREBIS as payers and patients opt for more cost-effective alternatives[1][5].

Market Growth and Projections

Despite these challenges, the global HIV drugs market is expected to grow. The market size is projected to increase from $31.33 billion in 2022 to $44.72 billion by 2031, at a CAGR of 4.70% during the forecast period[4].

Competitive Landscape

To remain competitive, pharmaceutical companies, including those marketing DUTREBIS, need to focus on innovation, patient compliance, and demonstrating better safety and efficacy compared to existing therapies. The rise of Biktarvy and other TAF-based regimens sets a high bar for new and emerging therapies[1].

Regulatory and Market Environment

The regulatory environment and market dynamics are crucial for the financial trajectory of DUTREBIS.

Regulatory Scrutiny

Regulatory scrutiny, especially around larger deals and product bundling, can impact the market strategy and pricing of HIV-1 drugs. For instance, the Federal Trade Commission's case against Amgen and Horizon Therapeutics highlights the need for careful planning in M&A activities[2].

Life Sciences Dealmaking

The life sciences sector, including pharmaceuticals, is expected to see increased dealmaking activity in 2024, driven by the need to replenish pipelines and offset the loss of exclusivity for key products. This could lead to strategic acquisitions and partnerships that might affect the market position of DUTREBIS[2][3].

Key Takeaways

• Shift to STRs: The preference for Single-Tablet Regimens over Multi-Tablet Regimens is a significant trend affecting DUTREBIS.
• TAF-Based Regimens: The transition from TDF to TAF-based regimens has impacted the sales of various HIV-1 therapies.
• Patent Expiry: Upcoming patent expiries and generic competition will increase pricing pressure.
• Market Growth: Despite challenges, the global HIV drugs market is expected to grow.
• Regulatory Environment: Regulatory scrutiny and market dynamics play a crucial role in the financial trajectory of HIV-1 drugs.

FAQs

What is the current trend in the HIV-1 treatment market?

The current trend is a shift from Multi-Tablet Regimens (MTRs) to Single-Tablet Regimens (STRs) due to improved patient compliance and reduced pill burden.

How does the transition from TDF to TAF-based regimens affect DUTREBIS?

The transition to TAF-based regimens, known for their improved safety profile, has led to a decline in sales for TDF-based regimens, including those similar to DUTREBIS.

What impact do patent expiries have on the HIV-1 treatment market?

Patent expiries lead to the entry of generic drugs, increasing competition and reducing pricing power for branded drugs like DUTREBIS.

How is the global HIV drugs market projected to grow?

The global HIV drugs market is expected to grow from $31.33 billion in 2022 to $44.72 billion by 2031, at a CAGR of 4.70%.

What are the key factors affecting the financial trajectory of DUTREBIS?

Key factors include the shift to STRs, the transition to TAF-based regimens, patent expiries, and increased generic competition.

Sources

1. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
2. Oliver Wyman: Life Sciences Dealmaking Poised To Rebound In 2024.
3. Deloitte: Value creation: M&A, partnerships, collaborations, new sources of capital, and shifting portfolios.
4. InsightAce Analytic: Global HIV Drugs Market Share, Size, Growth and Forecast to 2031.
5. DGRA: A comparative study of the different approaches for approval of new drugs.