BENICAR HCT Drug Patent Profile

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

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

The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for BENICAR HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	17
Drug Prices:	Drug price information for BENICAR HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENICAR HCT
What excipients (inactive ingredients) are in BENICAR HCT?	BENICAR HCT excipients list
DailyMed Link:	BENICAR HCT at DailyMed

See drug prices for BENICAR HCT

See drug sales revenues for BENICAR HCT

Recent Clinical Trials for BENICAR HCT

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

Sponsor	Phase
EMS	Phase 3
Daiichi Sankyo Co., Ltd.	N/A
Chinese PLA General Hospital	Phase 4

See all BENICAR HCT clinical trials

Pharmacology for BENICAR HCT

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for BENICAR HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	20 mg/12.5 mg	021532	1	2007-05-11
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	40 mg/12.5 mg and 40 mg/25 mg	021532	1	2007-02-15

US Patents and Regulatory Information for BENICAR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	AB	RX	Yes	No
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	AB	RX	Yes	No
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	AB	RX	Yes	Yes

Expired US Patents for BENICAR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	5,616,599*PED
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	5,616,599*PED
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	6,878,703*PED
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	6,878,703*PED

International Patents for BENICAR HCT

See the table below for patents covering BENICAR HCT around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	200303911	Medicinal compositions.
China	1188645
China	1121859
South Korea	0128289

Supplementary Protection Certificates for BENICAR HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
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	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

Market Dynamics and Financial Trajectory for BENICAR HCT

Last updated: December 9, 2025

Executive Summary

Benicar HCT (olmesartan medoxomil and hydrochlorothiazide) is a combination antihypertensive medication primarily used to treat high blood pressure. Since its launch in the early 2000s, it has maintained a significant market presence owing to its efficacy, safety profile, and manufacturer strategies. However, recent patent expirations, generic competition, and evolving treatment guidelines have significantly impacted its market dynamics. This report examines the current market landscape, key drivers, challenges, and the financial trajectory of Benicar HCT, providing insights critical for stakeholders seeking strategic decisions.

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Introduction

Benicar HCT, marketed primarily by Daiichi Sankyo, combines the angiotensin receptor blocker (ARB) olmesartan medoxomil with hydrochlorothiazide (HCTZ), a thiazide diuretic. Approved by the FDA in 2002, it quickly became a prominent agent in the antihypertensive class.

Key components:

Parameter	Details
Active Ingredients	Olmesartan medoxomil + Hydrochlorothiazide
NDC Codes	Various NDC codes, e.g., 00002-5170- -- (Daiichi Sankyo)
Approval Year	2002
Route of Administration	Oral
Therapeutic Class	Antihypertensive, Angiotensin receptor blocker (ARB) + Diuretic

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Market Overview

Global and U.S. Market Size

The global antihypertensive drug market was valued at approximately USD 35 billion in 2022 and is projected to grow at a CAGR of 3-4% through 2030. The U.S. remains the largest single market, accounting for over 40% of sales, valued around USD 15 billion (2022 data).

Market Share and Sales

Year	Estimated U.S. Sales (USD)	Market Share	Notes
2017	~$400 million	6-8%	Pre-patent expiration
2020	~$300 million	4-6%	Post-generic entry
2022	~$150 million	2-3%	Declined due to generics

Note: Sales decline observed primarily after patent expiry in 2018.

Patents and Market Exclusivity

Daiichi Sankyo held several patents protecting Benicar HCT:

Patent Type	Expiration Date	Significance
Primary Composition Patent	2018	Patent expiry allowed generics to enter the market
Method of Use / Formulation	2020	Limited extension, did not prevent generics’ entry

With patent expiries, biosimilar generics emerged, intensifying price competition.

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Market Drivers

Clinical Efficacy and Safety Profile

• Demonstrates significant blood pressure reduction.
• Well-tolerated with a favorable safety profile.
• Proven to reduce cardiovascular events (e.g., strokes, myocardial infarction), bolstering physician preference.

Evolving Treatment Guidelines

• American College of Cardiology/American Heart Association (ACC/AHA) guidelines favor ARB/diuretic combinations like Benicar HCT in specific hypertensive populations.
• Emphasis on combination therapy for better adherence and control.

Formulation and Patent Strategies

• Daiichi Sankyo's pipeline focus on innovative formulations and combination regimens to extend lifecycle.
• Co-marketing collaborations with pharmacy benefit managers (PBMs) and payers to maintain visibility and formulary positioning.

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Market Challenges

Patent Expiry and Generic Competition

• The primary patent's expiry in 2018 precipitated a sharp sales decline.
• Multiple generic versions (e.g., olmesartan/HCTZ) entered the market in 2018-2019 with significantly lower pricing.

Pricing and Reimbursement Pressures

• Payers and PBMs favor generics, leading to a reimbursement shift.
• Rebate dynamics often favor generic brands, squeezing branded drug profitability.

Market Saturation and Competition from Newer Agents

• Newer antihypertensives (e.g., sacubitril/valsartan, renin inhibitors) have entered the scene.
• Fixed-dose combinations with improved tolerability or fewer pills are preferred.

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Financial Trajectory Analysis

Pre-Patent Period (2002-2018)

• Peak sales occurred between 2012 and 2016.
• Estimated global sales: USD 1.2 billion (peak year 2015).
• U.S. market accounted for about 50% (~USD 600 million).

Post-Patent Expiry (2018 onward)

Year	Estimated U.S. Sales	Decline (%)	Key Factors
2018	~$400 million	33%	Patent expiry, generic entry
2019	~$250 million	37.5%	Increasing generic competition
2020	~$150 million	40%	Market saturation, price erosion
2021-22	<$150 million	Stable/declining	Market stabilization with generics reigning

Revenue Impact for Daiichi Sankyo

• Transition from branded flagship product to primarily generic sales resulted in a revenue drop.
• Limited upside from existing patents or formulations.
• Focus shifted toward pipeline and innovative combinations.

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Comparative Analysis with Similar ARB/HCTZ Drugs

Drug	Brand Name	Market Share (2022)	Patent Status	Key Competition
Olmesartan/HCTZ	Benicar HCT	2-3%	Patents expired	Generics dominate
Losartan/HCTZ	Hyzaar	4-5%	Patents expired	Generics, new agents
Valsartan/HCTZ	Diovan HCTZ	1-2%	Patents expired	Competition from ARBs, generics

The market share of branded combinations steadily declines with expired patents.

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Future Outlook and Growth Opportunities

Strategic Focus Areas

• Line Extension and Fixed-Dose Combinations: Developing novel formulations or fixed-dose combos with improved adherence.
• Biologics and Biosimilars: Potential future entrants in hypertensive management.
• Personalized Medicine: Genetic markers guiding ARB selection could optimize therapy.

Market Expansion

• Emerging Markets: Growing middle classes in Asia, Latin America, and Africa present expansion avenues.
• Regulatory Environment: Patent nationalizations and regulatory barriers may influence timing and strategies.

Impact of Policy Changes

• Continued emphasis on cost-effective therapies will favor generics.
• Incentives for biosimilars and biosimilar-like innovations could alter dynamics.

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Key Takeaways

• Patent expiries have significantly reduced sales, shifting Benicar HCT's role to a branded niche product.
• Generics dominate the antihypertensive combination segment, with pricing pressures constraining profitability.
• Market growth is mainly driven by emerging markets and innovative formulations; however, the core U.S. market remains saturated.
• Innovative strategies, such as fixed-dose combinations with fewer pills and personalized therapies, represent future growth pathways.
• Regulatory and policy pressures favor cost-containment, further challenging branded drug revenues.

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Frequently Asked Questions (FAQs)

1. What caused the decline in Benicar HCT's sales after 2018?
   The primary driver was patent expiry in 2018, which allowed generic versions to enter the market, leading to substantial price competition and volume-shifting away from the branded product.

2. Are there any ongoing patent protections or exclusivities for Benicar HCT?
   No, the key patents expired in 2018-2020. Future exclusivities are unlikely unless Daiichi Sankyo files for new formulations or delivery methods.

3. How does Benicar HCT compare to its generic competitors?
   Generics typically sell at 80-90% lower prices than branded Benicar HCT, dominating the market share since patent expiry, with minimal difference in efficacy and safety.

4. What are the strategic options for Daiichi Sankyo regarding Benicar HCT?
   Strategies include developing innovative fixed-dose combinations, exploring new indications, or focusing on pipeline drugs and biosimilars outside traditional markets.

5. What is the outlook for antihypertensive combination therapies in the next decade?
   The market will likely favor generic combinations unless new formulations or personalized approaches demonstrate superior adherence or outcomes, maintaining volume but pressure on margins.

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References

1. MarketResearch.com. (2022). Global Antihypertensive Drugs Market.
2. FDA. (2002). FDA Approval Letter for Benicar HCT.
3. Daiichi Sankyo Annual Reports. (2017-2022).
4. EvaluatePharma. (2022). Drug Market Analytics Report.
5. American College of Cardiology. (2017). Hypertension Guidelines.

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This analysis offers a comprehensive overview tailored for industry stakeholders, highlighting crucial market trends, challenges, and strategic considerations for Benicar HCT moving forward.