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. Six 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
Patent Applications:	6
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
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-005	Jul 23, 2010
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-004	Jul 23, 2010
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-002	Jul 23, 2010
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-003	Jul 23, 2010

International Patents for TRIBENZOR

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

Country	Patent Number	Title	Estimated Expiration
Germany	69329982
Germany	69231798
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)
Australia	647887
Australia	3988093
Denmark	0503785
New Zealand	247750	4-CARBOXYIMIDAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS THEREOF

Supplementary Protection Certificates for TRIBENZOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
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	SPC/GB03/024	United Kingdom		PRODUCT NAME: OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHAMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 50202.00.00 20020813; DE 50202.01.00 20020813; DE 50202.02.00 20020813; DE 50205.00.00 20020813; DE 50205.01.00 20020813; DE 50205.02.00 20020813; UK PL 08265/0015 20030522; UK PL 08265/0016 20030522; UK PL08265/0017 20030522
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0503785	03C0037	France		PRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
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	C00503785/02	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP

Market Dynamics and Financial Trajectory for the Drug: TRIBENZOR

Introduction

TRIBENZOR, a fixed-dose combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide, was approved by the U.S. Food and Drug Administration (FDA) in July 2010 for the treatment of hypertension. This article delves into the market dynamics and financial trajectory of TRIBENZOR, highlighting its impact, sales performance, and the competitive landscape.

Approval and Launch

TRIBENZOR was introduced by Daiichi Sankyo as a three-in-one combination product designed to simplify dosing regimens and reduce pill burden for patients with hypertension. The FDA approval marked a significant milestone, as it addressed the need for a more convenient and effective treatment option for patients not adequately controlled on any two of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers, and diuretics[4].

Market Need and Patient Compliance

Hypertension is a prevalent condition, with approximately 56% of patients not reaching the recommended blood pressure goals. More than two-thirds of patients require two or more antihypertensive medications to achieve goal blood pressure control. TRIBENZOR's fixed-dose combination was seen as a solution to improve patient compliance, as it reduced the complexity of multiple pill regimens[4].

Clinical Efficacy

Clinical trials demonstrated that TRIBENZOR produced statistically significant reductions in both systolic and diastolic blood pressures compared to dual combination therapies. This efficacy, combined with its convenience, positioned TRIBENZOR as a valuable treatment option for managing hypertension[4].

Sales Performance

Upon its launch, TRIBENZOR showed promising sales figures. By the time Teva announced the approval of its generic version in 2016, TRIBENZOR had annual sales of approximately $240 million in the U.S.[1].

Revenue Trends

Daiichi Sankyo's financial reports indicate that TRIBENZOR contributed to the company's revenue growth. For instance, in the fiscal year following its approval, TRIBENZOR generated significant revenue, although specific annual figures varied. The drug was part of a broader portfolio that included other antihypertensive medications like Azor and Benicar[2].

Competitive Landscape

The antihypertensive market is highly competitive, with multiple players offering various combination therapies. TRIBENZOR competed with other fixed-dose combinations, such as Azor (amlodipine and olmesartan medoxomil), which also had substantial sales. Azor, for example, had annual sales of approximately $354.1 million in the U.S. by 2016[1].

Generic Competition

The approval of generic versions of TRIBENZOR by companies like Teva marked a significant shift in the market dynamics. Generic drugs often lead to a decline in sales for the branded version, as they offer a more affordable alternative. Teva's generic version of TRIBENZOR was part of its extensive portfolio of FDA-approved generic products, further enhancing its market presence[1].

Financial Impact on Daiichi Sankyo

The introduction and subsequent generic competition of TRIBENZOR had a mixed impact on Daiichi Sankyo's financials. While TRIBENZOR contributed to the company's revenue, the eventual generic competition likely reduced its market share and revenue over time.

Revenue and Profitability

Daiichi Sankyo's financial reports show that the company experienced fluctuations in revenue and profitability. The sales of TRIBENZOR and other antihypertensive drugs were part of a broader portfolio that influenced the company's overall financial performance. For instance, in fiscal 2016, the company reported revenue and profitability metrics that reflected both the success of its products and the challenges posed by generic competition[2].

Life-Cycle Management

Daiichi Sankyo's strategy included life-cycle management of its products to maintain market share and revenue. This involved maximizing sales through various marketing and sales efforts, as well as exploring additional indications and geographic markets. The company also collaborated with other pharmaceutical companies, like Ranbaxy, to enhance its generic drug business and maintain cost efficiency[3].

Conclusion

TRIBENZOR's market dynamics and financial trajectory are characterized by its innovative approach to treating hypertension, significant sales performance, and the eventual impact of generic competition.

Key Takeaways

• Innovative Treatment: TRIBENZOR simplified dosing regimens and improved patient compliance.
• Sales Performance: The drug generated substantial revenue, with annual sales of approximately $240 million in the U.S. by 2016.
• Generic Competition: The approval of generic versions by companies like Teva affected TRIBENZOR's market share and revenue.
• Financial Impact: TRIBENZOR contributed to Daiichi Sankyo's revenue but faced challenges from generic competition.
• Life-Cycle Management: Daiichi Sankyo employed strategies to maximize sales and maintain market share.

FAQs

Q1: What is TRIBENZOR, and how does it differ from other antihypertensive medications?

TRIBENZOR is a fixed-dose combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide. It differs from other medications by combining three antihypertensive drug classes into a single pill, simplifying dosing regimens and reducing pill burden.

Q2: How did the FDA approval of TRIBENZOR impact the market?

The FDA approval of TRIBENZOR introduced a more convenient and effective treatment option for patients with hypertension, addressing the need for simpler dosing regimens and potentially improving patient compliance.

Q3: What was the sales performance of TRIBENZOR before the introduction of generic versions?

Before the introduction of generic versions, TRIBENZOR had annual sales of approximately $240 million in the U.S.

Q4: How did the approval of generic versions affect TRIBENZOR's market share?

The approval of generic versions by companies like Teva likely reduced TRIBENZOR's market share and revenue, as generic drugs offer more affordable alternatives.

Q5: What strategies did Daiichi Sankyo employ to manage the life cycle of TRIBENZOR?

Daiichi Sankyo employed strategies such as maximizing sales through marketing and sales efforts, exploring additional indications, and collaborating with other pharmaceutical companies to enhance its generic drug business and maintain cost efficiency.

Sources

1. Teva Announces Approval of Generic Tribenzor® in the United States. Teva Pharmaceutical Industries Ltd.
2. Reference Data. Daiichi Sankyo.
3. DAIICHI SANKYO CO., LTD. Annual Report. Daiichi Sankyo.
4. FDA APPROVES TRIBENZOR™, A NEW THREE-IN-ONE .... Daiichi Sankyo, Inc.