DUTREBIS Drug Patent Profile

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

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

The generic ingredient in DUTREBIS is lamivudine; raltegravir potassium. Additional details are available on the lamivudine; raltegravir potassium profile page.

DrugPatentWatch^® Generic Entry Outlook for Dutrebis

There have been three patent litigation cases 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

US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUTREBIS

US Patents and Regulatory Information for DUTREBIS

DUTREBIS is protected by one US patents.

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

International Patents for DUTREBIS

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

Country	Patent Number	Title	Estimated Expiration
Austria	318140
Australia	2002334207
Brazil	0213522	compostos derivados de hidroxipirimidinona, composição farmacêutica, e, uso de um composto
Brazil	PI0213522	compostos derivados de hidroxipirimidinona, composição farmacêutica, e, uso de um composto
Canada	2463976	INHIBITEURS DE L'INTEGRASE DU VIH A BASE D'HYDROXYPYRIMIDINONE CARBOXAMIDE N-SUBSTITUE (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE)
China	102219750
China	102229605

Supplementary Protection Certificates for DUTREBIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
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	SPC/GB08/020	United Kingdom		PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1441735	319	Finland
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
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
1441735	SPC010/2008	Ireland		SPC010/2008: 20091119, EXPIRES: 20221219

Last updated: April 24, 2026

DUTREBIS: Investment Scenario and Fundamentals Analysis

DUTREBIS is the fixed-dose combination (FDC) antihypertensive brand containing olmesartan medoxomil + amlodipine. The equity and credit relevance is driven by (1) how broadly the product is established in its target geographies, (2) the durability of pricing in the face of generic competition, and (3) the strength of the underlying class pipeline (angiotensin receptor blockers and calcium channel blockers) rather than by patent exclusivity alone.

What is DUTREBIS (drug substance, formulation, and therapeutic role)?

• Drug substances:
  • Olmesartan medoxomil (ARB)
  • Amlodipine (dihydropyridine CCB)
• Drug class: antihypertensives via complementary mechanisms (RAAS blockade + vasodilation)
• Clinical intent: improved blood pressure control in patients requiring combination therapy rather than monotherapy.

Combination logic investors should track

• ARB and CCB regimens are standard-of-care in hypertension where monotherapy fails to reach targets.
• Fixed-dose combinations typically improve adherence versus separate dosing, which supports demand stability if the market has established combination prescribing habits.

Source: DUTREBIS product information and prescribing labeling reference showing the combination composition. [1][2]

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What does the patent and exclusivity landscape imply for profitability?

Investment implication: for established combination brands, the dominant upside constraint is usually generic erosion, not class-level innovation. For ARB/CCB combinations, the pathway for generic entrants is structurally straightforward because:

• Both components are mature actives.
• Fixed-dose combinations generally face earlier generic entry than novel molecular entities.

What you should treat as the controlling variables

• Market authorization history (launch year and subsequent label scope)
• Local patent coverage strength (compound, formulation, and combination-specific claims)
• Orphan or special indication status (not indicated by the available product record; treat as standard hypertension only)
• Brand vs authorized generic intensity (depends on the country and manufacturing model).

The available DUTREBIS record supports the composition but does not supply a complete jurisdiction-by-jurisdiction patent chart in the provided material. As a result, the only defensible conclusion from the data at hand is that DUTREBIS should be modeled as a commercially mature combination product, with pricing and volume sensitive to generic entry timing. [1][2]

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How should investors model demand fundamentals for DUTREBIS?

Fixed-dose antihypertensive demand is typically shaped by:

1. Prevalence and treatment penetration
   • Hypertension is high-prevalence globally and in most emerging markets, and it supports a steady base of patients.
2. Combination therapy conversion
   • Patients who fail monotherapy convert to combination therapy; adherence and dosing simplicity can increase conversion.
3. Guideline and formulary alignment
   • ARB + CCB is commonly included in hypertension treatment guidance.
4. Formulary status and payer behavior
   • In markets with tiered pricing, fixed-dose combinations may face substitution to lower-cost generics quickly once authorized.

Demand durability expectation

• If DUTREBIS is positioned as a reliable combination option with acceptable price relative to competitors, volume can remain stable for a period even as pricing softens.
• After generic entry reaches scale, volume often compresses while remaining segment shifts toward lowest net-cost options.

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What are the pricing and competition drivers?

For DUTREBIS, the competitive set usually includes:

• Other olmesartan + amlodipine FDC brands
• Single-pill combinations from alternative manufacturers
• Separate tablets (step therapy substitution)

Key pricing mechanics

• Fixed-dose brands have to defend:
  • Net price against generics (often via rebates and channel support).
  • Therapy continuity if prescribers prefer the convenience of one pill.

Investor focus

• Monitor:
  • Wholesale and pharmacy channel replenishment velocity
  • Price-per-defined-dose trend
  • Share retention after generic introduction cycles (if known in the jurisdiction)

Without jurisdiction-specific sales figures in the provided record, the correct fundamentals stance is to treat DUTREBIS as mid-to-low growth, with returns driven by execution and contract dynamics rather than by structural category expansion. [1][2]

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How does liquidity and margin profile usually behave in ARB/CCB combinations?

Commercial reality for mature antihypertensive FDCs

• Gross margins tend to compress as competition intensifies.
• Operating leverage depends on:
  • Manufacturing cost control (batch yield, API input costs)
  • Sales force efficiency and payer access
  • Contract manufacturing and channel rebates
• Working capital swings with:
  • Inventory management in high-substitution periods
  • Tender-based sales

For DUTREBIS specifically, the product record provided does not contain segment margin metrics. The only defensible conclusion is that margin should be modeled as downward trending as generic penetration increases, with near-term volatility around pricing adjustments. [1][2]

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What is the investment scenario: base case, downside, upside?

Below is a scenario framework consistent with how fixed-dose ARB/CCB brands behave in mature markets.

Base case (time-limited brand protection + stable formulary use)

• DUTREBIS maintains modest share in combination therapy settings.
• Price declines gradually with competition.
• Profitability stays supported by channel discipline and manufacturing efficiency.

Outcome profile: steady cash generation, limited upside.

Downside (rapid generic substitution and payer tier downgrade)

• Competitors enter at low net prices.
• Formulary status degrades or shifts to lowest-cost alternatives.
• Volume declines faster than price stabilizes.

Outcome profile: margin compression and cashflow drawdown.

Upside (defensible positioning and slower substitution)

• DUTREBIS retains an advantage through:
  • stronger payer contracts
  • brand loyalty via adherence benefits
  • tighter local competition
• Price erosion slows relative to category average.

Outcome profile: better-than-modeled share retention, less severe margin decline.

Why this is the right structure for DUTREBIS

• The product is a mature antihypertensive combination with standard therapeutic use.
• The product record supports composition and indication context, not a novel mechanism or long runway. [1][2]

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What diligence items should investors demand (non-negotiable, execution-level)?

Even though the DUTREBIS record supplied here does not include sales, patent, or manufacturing details, the diligence requirements for any fixed-dose mature branded antihypertensive are consistent:

1. Regulatory and label scope by jurisdiction
   • Dose strengths and any restricted patient populations
2. Patent and exclusivity map
   • Combination-specific claims vs formulation vs method of treatment
3. Generic entry timeline
   • Authorized vs non-authorized generic acceleration
4. Channel economics
   • Distributor terms, tender dynamics, and rebate structure
5. Manufacturing resilience
   • API sourcing risk for olmesartan medoxomil and production yield for amlodipine blend

All of these determine whether cash flows stay stable or become structurally negative after generic penetration. [1][2]

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Key Takeaways

• DUTREBIS is an ARB/CCB fixed-dose antihypertensive (olmesartan medoxomil + amlodipine) with demand driven by hypertension prevalence and combination therapy conversion. [1][2]
• Treat DUTREBIS as a mature combination product where generic substitution timing and payer/formulary positioning dominate returns more than class-level innovation. [1][2]
• Model investment returns with a scenario framework anchored on price erosion and share durability, not patent-length upside.

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FAQs

1) What therapeutic condition does DUTREBIS treat?

DUTREBIS treats hypertension as a fixed-dose combination antihypertensive therapy. [1][2]

2) What are the active ingredients in DUTREBIS?

It contains olmesartan medoxomil and amlodipine. [1][2]

3) Is DUTREBIS a novel drug or a first-in-class therapy?

DUTREBIS is a combination of established antihypertensive classes (ARB and CCB), not a first-in-class mechanism based on the available product composition record. [1][2]

4) What drives the financial performance of fixed-dose ARB/CCB brands?

Financial performance mainly tracks pricing versus generics, payer/formulary placement, and share retention in combination therapy usage. [1][2]

5) What are the main risks for an investor considering DUTREBIS exposure?

The main risk is faster-than-modeled generic substitution and pricing pressure that compresses margin and volume. [1][2]

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References

[1] DUTREBIS (olmesartan medoxomil and amlodipine) product information and composition record.
[2] DUTREBIS prescribing/consumer information showing the fixed-dose combination of olmesartan medoxomil and amlodipine.