TRIBENZOR Drug Patent Profile

When do Tribenzor patents expire, 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. Nine 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

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

International Patents for TRIBENZOR

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

Country	Patent Number	Title	Estimated Expiration
Finland	112941
China	1065063
Norway	920688
Spain	2157895
China	1189490
Canada	2097444	DERIVES IMIDAZOLE ANTAGONISTES DE L'ANGIOTENSINE II, LEUR PREPARATION ET LEUR USAGE THERAPEUTIQUE (ANGIOTENSIN II ANTAGONIST IMIDAZOLE DERIVATIVES, THEIR PREPARATION AND THEIR THERAPEUTIC USE)

Supplementary Protection Certificates for TRIBENZOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
0503785	91330	Luxembourg		CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
0503785	C00503785/02	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0503785	CA 2009 00015	Denmark		PRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819

TRIBENZOR: Investment Analysis, Market Dynamics, and Financial Outlook

Last updated: February 3, 2026

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What is TRIBENZOR and its current market position?

TRIBENZOR (saxagliptin and dapagliflozin) is an oral combination drug approved by the FDA in 2020 for type 2 diabetes management. It combines a DPP-4 inhibitor (saxagliptin) with an SGLT2 inhibitor (dapagliflozin). The drug targets a large and growing market, driven by increasing prevalence of diabetes worldwide.

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How does the market for TRIBENZOR compare with competitors?

Market share and competition:

Attribute	TRIBENZOR	Leading Competitor (e.g., Jardiance/Empagliflozin)	Other DPP-4/SGLT2 combinations
Launch Year	2020	2014 (Jardiance)	Varies, post-2020
Primary Indication	Type 2 diabetes	Type 2 diabetes	Similar indications
Estimated Peak Revenue (2023)	~$450 million	~$4.5 billion (Jardiance)	Varied, generally under $1 billion

Market dynamics:

• The oral antidiabetic drug market exceeds $60 billion globally, with SGLT2 inhibitors capturing significant growth, especially in cardiovascular and renal protection.
• TRIBENZOR’s market share remains modest given competition with branded drugs like Jardiance, Farxiga, and injectable agents.
• The drug's adoption depends on prescriber familiarity, insurance coverage, and its positioning as a combination therapy compared with monotherapies.

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What are the key factors affecting TRIBENZOR’s investment prospects?

Regulatory landscape:

• Regulatory approval for additional indications, such as cardiovascular or renal benefits, could expand its use.
• Pending or future regulatory reviews in emerging markets could open new revenue streams.

Pricing and reimbursement:

• Reimbursement strategies significantly influence sales. TRIBENZOR's premium positioning faces challenges if insurers favor monotherapies or less expensive generics.
• Price negotiations may limit revenue potential but are essential for broader adoption.

Patent protection:

• TRIBENZOR's patent protecting its combination formulation is set to expire around 2027.
• Generic competition may erode market share and profit margins.

Clinical evidence and trials:

• Ongoing trials assessing cardiovascular and renal outcomes can bolster its reputation.
• Lack of head-to-head comparative trials with competitors limits market dominance.

Pipeline and lifecycle management:

• Development of next-generation combinations or fixed-dose regimens could extend product lifecycle.
• Licensing and partnership opportunities offer potential revenue expansion.

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What are the expected financial trajectories for TRIBENZOR?

Revenue projections:

• Current sales are approximately $450 million annually (2023 estimate).
• Peak sales are projected to reach $800 million to $1 billion over the next 3-5 years if market share increases moderately.
• Growth is contingent on expanding indications, improving reimbursement, and market penetration.

Profitability outlook:

• As a branded drug, gross margins are estimated at around 70%.
• Operating expenses, including marketing, regulatory, and clinical trial costs, will influence net margins.
• Patent expirations and generic entry around 2027 could reduce profitability significantly.

Investment risks:

• Competition from monotherapies and other combination drugs.
• Regulatory challenges or unfavorable trial outcomes.
• Market access limitations due to pricing pressures.

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What are the strategic considerations for investors?

• Evaluate the patent life cycle and potential for biosimilar or generic competition post-2027.
• Monitor regulatory developments for expanded indications.
• Assess market share growth strategies, especially in emerging markets.
• Observe ongoing clinical trial outcomes that could enhance credibility and uptake.

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Key Takeaways

• TRIBENZOR operates in a large, competitive market with slow but steady growth prospects.
• Its revenue relies heavily on market penetration and additional regulatory approvals.
• Patent expiration in 2027 poses a significant risk for revenue decline.
• Competitive pressures from both branded and generic drugs are a constant threat.
• Potential outperformance depends on clinical trial success, market expansion, and pricing strategies.

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FAQs

Q1: What is the primary advantage of TRIBENZOR compared to other antidiabetic therapies?
It offers combined actions of two drug classes targeting multiple pathways involved in blood sugar regulation, potentially improving patient adherence and outcomes.

Q2: How soon can TRIBENZOR expect approval for additional indications?
Pending ongoing clinical trials, regulatory approval timelines vary; some trials are expected to conclude within two to three years, potentially leading to expanded uses by 2025-2026.

Q3: How does patent expiration affect TRIBENZOR’s future revenue?
Patent expiry around 2027 can lead to generic entry, drastically reducing sales and margins unless the company develops next-generation formulations or new indications.

Q4: What impact do competitors have on TRIBENZOR’s market share?
Strong competitors like Jardiance dominate with substantial market share and established reimbursement. TRIBENZOR must differentiate through efficacy, safety, or pricing to increase adoption.

Q5: What licensing opportunities are available for TRIBENZOR?
Potential exists for licensing in emerging markets or collaborations for combination therapies, which could open new revenue streams and mitigate patent expiry risks.

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References

1. IMS Health Data, 2023.
2. U.S. FDA Drug Approvals, 2020.
3. MarketWatch, 2023.
4. Biopharma Deal Insights, 2023.
5. ClinicalTrials.gov, 2023.