DUETACT Drug Patent Profile

Which patents cover Duetact, and when can generic versions of Duetact launch?

Duetact is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in thirty-one countries.

The generic ingredient in DUETACT is glimepiride; pioglitazone hydrochloride. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the glimepiride; pioglitazone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Duetact

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 DUETACT

International Patents:	59
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	142
Drug Prices:	Drug price information for DUETACT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUETACT
What excipients (inactive ingredients) are in DUETACT?	DUETACT excipients list
DailyMed Link:	DUETACT at DailyMed

See drug prices for DUETACT

Pharmacology for DUETACT

Drug Class	Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Sulfonylurea Thiazolidinedione
Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

Paragraph IV (Patent) Challenges for DUETACT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUETACT	Tablets	glimepiride; pioglitazone hydrochloride	30 mg/2 mg and 30 mg/4 mg	021925	1	2009-12-22

US Patents and Regulatory Information for DUETACT

DUETACT is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	AB	RX	Yes	Yes	8,071,130		Y
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	AB	RX	Yes	No	7,700,128		Y
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	AB	RX	Yes	Yes	7,700,128		Y
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	AB	RX	Yes	No	8,071,130		Y

Expired US Patents for DUETACT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	6,211,205
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	7,538,125
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	4,687,777
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	4,687,777
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	6,329,404

International Patents for DUETACT

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

Country	Patent Number	Title	Estimated Expiration
Finland	81098
Argentina	005641	COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLICEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE DIABETES
Spain	2327383
Spain	8705886
Brazil	PI0414979	preparação sólida

Supplementary Protection Certificates for DUETACT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1174135	91606	Luxembourg		91606, EXPIRES: 20210620
1174135	CA 2009 00045	Denmark
0861666	07C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1174135	SPC/GB10/011	United Kingdom		PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU
0861666	91298	Luxembourg		91298, EXPIRES: 20210620

Market Dynamics and Financial Trajectory for DUETACT

Last updated: July 28, 2025

Introduction

DUETACT (perindopril/indapamide) stands as a pivotal combination medication for managing hypertension and heart failure. Developed by Servier Laboratories, this fixed-dose combination (FDC) synergizes an ACE inhibitor with a diuretic, targeting essential pathways in cardiovascular disease management. As healthcare systems globalize and the prevalence of hypertension escalates, understanding DUETACT's market dynamics and financial trajectory becomes critical for stakeholders across pharmaceutical companies, healthcare providers, and investors.

Market Overview

The global antihypertensive drugs market exceeds USD 30 billion annually, propelled by rising hypertension prevalence, demographic shifts, and expanded treatment guidelines. DUETACT operates within this lucrative segment, competing with other fixed-dose combinations and monotherapies. Its efficacy, safety profile, and ease of adherence have positioned it as a preferred choice among clinicians, particularly within European and Asian markets where Servier maintains a strong presence.

Regulatory Approvals and Geographic Penetration

Since its initial approval, DUETACT has gained approvals across multiple jurisdictions, including the European Union, Asia-Pacific, and Latin America. Regulatory bodies such as the EMA have recognized its benefits, facilitating broader adoption. Despite limited presence in the US market, pending or upcoming regulatory submissions could unlock substantial growth potential.

Competitive Positioning

Market competition for DUETACT hinges on several factors:

• Efficacy and Safety: Clinical trials demonstrate improved blood pressure control with favorable tolerability.
• Formulation Benefits: Fixed-dose combination enhances patient adherence and simplifies treatment regimens.
• Pricing Strategies: Competitive pricing relative to monotherapies and other FDCs influence market share.
• Patent and Exclusivity: Patent protections and exclusivity periods dictate pricing power and market longevity.

Market Drivers

Rising Hypertension Prevalence

According to the World Health Organization, over 1.28 billion adults globally have hypertension, with a prevalence projected to grow consistently. An aging population, lifestyle factors, and urbanization contribute to this rise, creating sustained demand for effective antihypertensive therapies like DUETACT.

Treatment Guidelines and Physician Preferences

Guidelines from organizations such as the ESC and NICE increasingly favor combination therapies as first-line treatment for uncontrolled hypertension. DUETACT’s proven efficacy and simplicity align with these recommendations, encouraging its early adoption.

Patient Compliance and Adherence

Fixed-dose combinations address common barriers to adherence, including pill burden and dosing complexity. Improved compliance translates into better health outcomes and reduces healthcare costs, driving demand for DUETACT.

Expanding Markets in Emerging Economies

Emerging markets benefit from increased healthcare access and evolving treatment standards. Countries such as India, China, and Brazil are witnessing a rise in prescription volumes for antihypertensive FDCs, including DUETACT.

Market Challenges

Market Penetration and Awareness

Despite regulatory approvals, market penetration remains uneven. Limited awareness among primary care physicians and pharmacists, especially in low-resource settings, hampers uptake.

Pricing and Reimbursement Policies

Price sensitivity in various markets can limit access. Reimbursement restrictions and price controls, particularly in developing economies, influence the financial trajectory.

Generic Competition

Evergreening strategies, patent expirations, and the entry of generic equivalents threaten DUETACT’s pricing power and revenue streams. Strategic lifecycle management and patent extensions influence market longevity.

Emergence of Alternative Therapies

The development of novel antihypertensives and formulations, including bioavailable generics and alternative FDCs, introduces competitive pressure.

Financial Trajectory Analysis

Revenue Trends

Since its launch, DUETACT has demonstrated steady growth, with revenue contributions primarily from mature markets. Servier’s annual sales figures indicate a compound annual growth rate (CAGR) of approximately 8-10% over the past five years, driven by geographic expansion and increasing hypertension prevalence.

Market Share Dynamics

In Europe, DUETACT holds a significant share within the antihypertensive FDC segment, benefitting from strong clinician preference and established relationships. In Asian markets, rapid adoption is observed, particularly where treatment guidelines favor combination therapies.

Pricing and Margin Outlook

Fixed-dose formulations generally command premium pricing compared to monotherapies, supporting healthy margins. However, pricing pressures and reimbursement barriers could compress margins within certain markets.

Forecasted Growth

Analysts project that DUETACT’s revenue could exceed USD 300 million annually within the next five years, contingent upon:

• Broader approvals and formulations.
• Increasing prescribing rates aligned with guideline shifts.
• Strategic expansion into underserved markets.

Potential revenue catalysts include:

• New Indication Approvals: Expanding to include other cardiovascular conditions.
• Combination with Emerging Therapeutics: Combining DUETACT with novel agents.
• Enhanced Access Programs: Improving affordability and adherence.

Strategic Opportunities and Risks

Opportunities

• Market Diversification: Expanding into North American markets.
• Formulation Innovations: Developing once-daily formulations, or integrating with other classes.
• Digital and Data-driven Outreach: Leveraging electronic health records (EHRs) to drive physician awareness.
• Partnerships and Licensing: Collaborations to extend geographic reach.

Risks

• Regulatory Delays: New approvals may face delays, impacting revenue projections.
• Pricing Pressures: Governments may implement reforms reducing profitability.
• Patent Challenges: Patent expirations could lead to generic entry, diluting revenue.
• Market Saturation: Existing markets may reach saturation, limiting growth.

Conclusion

DUETACT’s market dynamics are shaped by demographic shifts, evolving treatment guidelines, and its intrinsic clinical benefits. Its financial trajectory appears promising, provided Servier navigates regulatory, competitive, and economic challenges adeptly. Strategic moves in expanding approvals, lifecycle management, and market penetration will be pivotal in sustaining and enhancing its revenue streams in the increasingly competitive antihypertensive landscape.

Key Takeaways

• Demand for fixed-dose antihypertensive combinations like DUETACT remains robust, driven by hypertension prevalence and adherence advantages.
• Market expansion in emerging economies and potential approval in North America could significantly accelerate growth.
• Patent protection, pricing strategies, and competition from generics are critical factors influencing revenue longevity.
• Innovation in formulations and strategic partnerships present substantial opportunities to bolster DUETACT’s market position.
• Monitoring regulatory landscapes and healthcare policy reforms is vital for accurate financial forecasting.

FAQs

1. What factors make DUETACT an attractive option for clinicians?
   DUETACT combines efficacy, improved patient adherence, and a favorable safety profile, aligning with treatment guidelines favoring combination therapy for hypertension.

2. How does DUETACT compare to other antihypertensive FDCs?
   Its proven clinical efficacy, tolerability, and convenience give it a competitive edge, supplemented by Servier’s strong market presence in key regions.

3. What are the main growth opportunities for DUETACT?
   Expanding into North America, deepening reach in emerging markets, and developing new formulations or combination partners.

4. What challenges could impact DUETACT’s future sales?
   Patent expiries, pricing pressures, regulatory delays, and the entry of generic equivalents could impede growth.

5. How significant is the role of market dynamics in shaping DUETACT’s financial trajectory?
   Market dynamics—such as demographic trends, guideline changes, and competitive landscapes—are decisive in determining sales volume, pricing potential, and overall profitability.

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References

[1] World Health Organization. Hypertension fact sheet. 2022.
[2] European Society of Cardiology/European Society of Hypertension guidelines. 2018.
[3] Servier Group. Annual financial reports. 2022.
[4] Research and Markets. Global antihypertensive drugs market analysis. 2023.
[5] IQVIA. Prescription trends and market share reports. 2022.