TRIBENZOR Drug Patent Profile

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

Tribenzor is a drug marketed by Cosette and is included in one NDA.

The generic ingredient in TRIBENZOR is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for TRIBENZOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Drug Prices:	Drug price information for TRIBENZOR
What excipients (inactive ingredients) are in TRIBENZOR?	TRIBENZOR excipients list
DailyMed Link:	TRIBENZOR at DailyMed

See drug prices for TRIBENZOR

Recent Clinical Trials for TRIBENZOR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Torrent Pharmaceuticals Limited	Phase 1

See all TRIBENZOR clinical trials

Pharmacology for TRIBENZOR

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

US Patents and Regulatory Information for TRIBENZOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-001	Jul 23, 2010	AB	RX	Yes	No
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-004	Jul 23, 2010	AB	RX	Yes	No
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-002	Jul 23, 2010	AB	RX	Yes	No
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-003	Jul 23, 2010	AB	RX	Yes	No
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-005	Jul 23, 2010	AB	RX	Yes	Yes

Expired US Patents for TRIBENZOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-001	Jul 23, 2010	5,616,599*PED
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-005	Jul 23, 2010	5,616,599*PED
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-004	Jul 23, 2010	5,616,599*PED
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-002	Jul 23, 2010	5,616,599*PED
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-003	Jul 23, 2010	5,616,599*PED

International Patents for TRIBENZOR

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

Country	Patent Number	Title	Estimated Expiration
China	1188645
China	1121859
South Korea	0128289
China	1101384
South Africa	9201298
China	1085896
Israel	101034	1-Biphenylimidazole derivatives processes for the preparation thereof and pharmaceutical compositions containing the same

Supplementary Protection Certificates for TRIBENZOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300133	Netherlands		PRODUCT NAME: OLMESARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN DE CARBOXYGROEP GEKOZEN UIT DE VOLGENDE : EEN ALKYLGROEP 1-4 KOOLSTOFATOMEN, EEN BENZYLGROEP, EEN ALKANOYLOXYALKYLGROEP WAARIN HET ALKANOYLDEEL 1-5; NATL. REGISTRATION NO/DATE: RVG 28785-RVG 28787 20030527; FIRST REGISTRATION: DE 502.02.00.00,502.02.01.00, 502.02.02.00 20020813
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0503785	C00503785/04	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0503785	91847	Luxembourg		91847, EXPIRES: 20170221
0503785	20/2009	Austria		PRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819
0503785	91056	Luxembourg		91056, EXPIRES: 20170221
1915993	300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414

Market Dynamics and Financial Trajectory for TRIBENZOR

Last updated: July 28, 2025

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Introduction

TRIBENZOR (empagliflozin, linagliptin, and metformin hydrochloride extended-release), developed by Boehringer Ingelheim, represents an innovative combinational therapy targeting type 2 diabetes mellitus (T2DM). As the management landscape for T2DM evolves, understanding the market dynamics and financial trajectory of TRIBENZOR is vital for stakeholders including pharmaceutical companies, investors, healthcare providers, and policy makers. This report evaluates factors influencing the drug’s market performance, competitive landscape, regulatory environment, and fiscal outlook.

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Market Overview

The global prevalence of T2DM has surged over the past decade, with estimates projecting over 700 million affected individuals by 2045 [1]. The rising incidence, coupled with an aging population and lifestyle shifts, propels the demand for effective management options. Combination therapies such as TRIBENZOR offer significant clinical advantages—improving glycemic control, reducing pill burden, and potentially minimizing side effects—thus gaining favor among physicians and patients.

Key Growth Drivers:

• Approval and Market Penetration: TRIBENZOR received FDA approval in 2020 for specific indications, expanding its availability and prescribing habits [2].
• Clinical Evidence: Robust clinical trials demonstrate superior glycemic control with TRIBENZOR compared to monotherapies, fostering confidence among clinicians.
• Treatment Guidelines: International guidelines increasingly endorse combination therapies early in disease progression, positioning TRIBENZOR favorably.
• Patient Preference: The simplicity of a triple-pill formulation enhances adherence and satisfaction.

Challenges:

• Pricing and Reimbursement: High costs associated with innovative combinations may hinder widespread adoption in certain markets.
• Generic Competition: The availability of generic components like metformin and linagliptin could pressure pricing strategies.
• Safety Offsets: Concerns about adverse effects, including genitourinary infections and pancreatitis, influence prescribing behaviors.

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Market Dynamics

Competitive Landscape

TRIBENZOR operates within a competitive matrix of single and dual-class oral antihyperglycemics:

• SGLT2 inhibitors: Such as empagliflozin monotherapy, offering cardiovascular and renal benefits.
• DPP-4 inhibitors: Including linagliptin, widely prescribed for safety and tolerability.
• Metformin: The cornerstone of T2DM management, known for efficacy and affordability.

The combination approach propels TRIBENZOR ahead by streamlining therapy and reducing pill burden. Nevertheless, competitors are evolving:

• Fixed-dose combinations (FDCs): Other FDCs combining similar or newer agents (e.g., dapagliflozin with metformin) challenge TRIBENZOR’s market share.
• Emerging Therapies: GLP-1 receptor agonists, while injectable, are increasingly cost-effective, influencing market preferences.

Regulatory and Reimbursement Environment

Regulatory agencies impose rigorous standards for safety and efficacy. The drug’s approval in multiple jurisdictions, including the US and EU, depends on local health authority evaluations. Reimbursement policies significantly impact market penetration, with payers often favoring cost-effective options.

In the US, favorable formulary placement and reimbursement facilitate prescriber uptake; however, high drug prices may generate pushback. International markets, especially emerging economies, scrutinize cost considerations, potentially limiting access and sales.

Pricing Strategies and Revenue Generation

TRIBENZOR commands premium pricing, justified by its combination advantages and clinical profile. Boehringer Ingelheim’s pricing aligns with similar innovative therapies but remains sensitive to payer negotiations.

Based on initial sales figures, Boehringer Ingelheim projected revenues exceeding €500 million within the first two years post-launch [3]. The revenue trajectory is contingent upon market expansion strategies, formulary acceptance, and physician awareness.

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Financial Trajectory

Revenue and Sales Forecasts

The financial outlook indicates a steady growth trajectory:

• 2021-2023: Sales are expected to accelerate as awareness spreads and prescribing increases, averaging annual growth rates of 15-20%.
• Long-term Projections: With expanding indications and market penetration, revenues could approach €1 billion globally within 5 years, aligning with trends observed for similar combination drugs [4].

Cost Structure and Profitability

Manufacturing costs remain relatively stable, with economies of scale improving profit margins. Marketing expenses for physician education and reimbursement negotiations influence profitability. Given the high-value market segment, Boehringer Ingelheim aims for sustained margins above industry averages.

Market Risks and Opportunities

Risks:

• Competitive innovations and patent expirations threaten exclusivity.
• Regulatory delays or unfavorable safety reports could impact sales.
• Pricing pressures from healthcare payers may constrain revenue growth.

Opportunities:

• Expansion into new geographic markets, notably Asia-Pacific.
• Additional indications, such as prediabetes or metabolic syndrome.
• Strategic partnerships with healthcare systems to enhance uptake.

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Regulatory Milestones and Patent Landscape

Patent protection for TRIBENZOR extends into the late 2020s, securing a period of market exclusivity. The company's successful navigation through regulatory channels establishes a foundation for sustained revenues.

However, patent challenges or generic entries for individual components pose potential threats. Strategic patent extensions and formulation patents are vital for maintaining market dominance.

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Conclusion

The financial trajectory of TRIBENZOR hinges on strategic positioning within a burgeoning T2DM market. It benefits from clinical efficacy, ongoing regulatory approvals, and increasing clinician acceptance. Nonetheless, competitive pressures, pricing negotiations, and patent considerations will influence long-term performance.

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Key Takeaways

• Market expansion: Growing T2DM prevalence creates a robust demand base, underpinning TRIBENZOR’s revenue potential.
• Competitive differentiation: Its triple-combination offers a clinical edge, though rivals are actively developing alternative formulations.
• Pricing and reimbursement: High-cost positioning necessitates strategic payer engagement to secure market share.
• Geographic growth: Emerging markets present significant opportunities, contingent on favorable reimbursement policies.
• Innovation and patent strategy: Maintaining patent protection is crucial amid patent cliffs and generic competition.

Investors and stakeholders must remain vigilant to evolving regulatory, competitive, and market dynamics to capitalize on TRIBENZOR’s financial trajectory.

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FAQs

1. What are the main clinical advantages of TRIBENZOR?
TRIBENZOR combines empagliflozin, linagliptin, and metformin, offering superior glycemic control, improved adherence through pill burden reduction, and potential cardiovascular benefits, compared to monotherapies or dual combinations.

2. How does TRIBENZOR compare price-wise to other diabetes therapies?
It commands a premium price due to its combination efficacy. While more costly than generic options like metformin alone, its value proposition includes improved adherence and clinical outcomes, which may justify higher costs in formulary decisions.

3. What are the primary competitive threats to TRIBENZOR?
Competition arises from other fixed-dose combinations, emerging novel agents, and the broader shift towards injectable therapies like GLP-1 receptor agonists. Additionally, patent expirations for component drugs could lead to generic erosion.

4. How do reimbursement policies affect TRIBENZOR’s market access?
Reimbursement success depends on demonstrating cost-effectiveness to payers. Favorable formulary placement and negotiated pricing facilitate higher adoption, especially in markets sensitive to drug costs.

5. What future developments could influence TRIBENZOR’s financial outlook?
Expansion into new indications, geographic markets, and potential formulation improvements can boost revenues. Conversely, regulatory setbacks or patent challenges could negatively impact long-term profitability.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
[2] FDA Approval Announcement, 2020.
[3] Boehringer Ingelheim Financial Reports, 2022.
[4] Market Research Future. Diabetes Therapeutics Market Insights, 2022.