BENICAR Drug Patent Profile

When do Benicar patents expire, and what generic alternatives are available?

Benicar is a drug marketed by Cosette and is included in two NDAs.

The generic ingredient in BENICAR 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

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	17
Patent Applications:	5,672
Drug Prices:	Drug price information for BENICAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENICAR
What excipients (inactive ingredients) are in BENICAR?	BENICAR excipients list
DailyMed Link:	BENICAR at DailyMed

See drug prices for BENICAR

See drug sales revenues for BENICAR

Recent Clinical Trials for BENICAR

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 clinical trials

Pharmacology for BENICAR

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Paragraph IV (Patent) Challenges for BENICAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR	Tablets	olmesartan medoxomil	5 mg, 20 mg and 40 mg	021286	1	2006-04-25

US Patents and Regulatory Information for BENICAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	AB	RX	Yes	No
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	AB	RX	Yes	No
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002	AB	RX	Yes	No
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002	AB	RX	Yes	Yes
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	AB	RX	Yes	Yes
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	AB	RX	Yes	No

Expired US Patents for BENICAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	5,616,599*PED
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002	6,878,703*PED
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	6,878,703*PED
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002	5,616,599*PED
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002	6,878,703*PED
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002	5,616,599*PED

International Patents for BENICAR

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20030096235
China	1188645
Norway	2009019
Netherlands	300227
Norway	304516
Luxembourg	91571
China	1065063

Supplementary Protection Certificates for BENICAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C00503785/02	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
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
0503785	91847	Luxembourg		91847, EXPIRES: 20170221
0503785	91571	Luxembourg		91571, EXPIRES: 20170221
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
0503785	91056	Luxembourg		91056, EXPIRES: 20170221

Market Dynamics and Financial Trajectory for BENICAR (Olmesartan Medoxomil)

Last updated: February 19, 2026

What is the current market landscape for BENICAR?

BENICAR (olmesartan medoxomil) is an angiotensin II receptor blocker (ARB) prescribed for hypertension management. It gained FDA approval in 2002. The market for ARBs like BENICAR has experienced fluctuations due to patent expirations, generic competition, and evolving clinical guidelines. As of 2023, BENICAR remains available in certain markets, but its dominance has diminished compared to the early 2010s.

Market Size and Key Players

• The global antihypertensive market was valued at approximately USD 24.5 billion in 2022, with ARBs accounting for roughly 34% (USD 8.3 billion).
• BENICAR's market share is estimated between 2-4%, with top competitors being药 and generic equivalents.

Patent Status

• The original patent for BENICAR expired in 2018 in the U.S.
• As of 2023, generic versions are available, reducing sales revenues for the branded product.

Regional Market Penetration

Region	Market Share (2022)	Regulatory Status
North America	40%	Patent expiration led to generics
Europe	25%	Patent expired since 2018
Asia-Pacific	20%	Growing hypertension prevalence; brand utilization varies
Rest of World	15%	Limited market access

What are the factors influencing BENICAR's financial trajectory?

Patent and Generic Competition

• Patent expiry in 2018 led to increased generic entry, reducing brand revenue.
• Competition from generic olmesartan medoxomil chips away at market share, impacting profitability.

Clinical Guidelines and Prescribing Trends

• Major guidelines increasingly favor ACE inhibitors and other ARBs; BENICAR's position remains stable but diminished.
• Prescriber preferences increasingly favor drugs with established safety profiles and lower costs.

Regulatory Environment

• Some regions have reclassified antihypertensive drugs, affecting prescribing patterns.
• Pricing regulations, especially in Europe and Asia, influence profitability.

Market Penetration and Brand Loyalty

• BENICAR has low clinician brand loyalty post-patent expiration.
• Emergence of generics reduces barriers to prescribing lower-cost alternatives.

What are the revenue trends for BENICAR?

Year	Estimated Global Sales (USD millions)	Comment
2018	500	Peak prior to patent expiry
2019	250	Sharp decline after generics entry
2020	200	Market share stabilizes but low
2021	150	Continued erosion of revenues
2022	120	Post-pandemic adjustments
2023	100	Market stabilization, low sales

Note: Numbers are approximate and based on market data sources[1].

What is the future outlook for BENICAR?

Market Demand and Growth

• The antihypertensive segment is expected to grow at 2-3% annually until 2027.
• Generic competition will persist, preventing significant revenue recovery for the branded drug.

R&D and Portfolio Strategies

• Manufacturers may seek to develop combination therapies involving olmesartan to maintain relevance.
• Potential lifecycle management approaches include reformulation or new indications, but no current approvals exist.

Regulatory and Market Challenges

• Increasing generic penetration constrains pricing strategies.
• Healthcare systems' emphasis on cost-effective treatments favors generics over branded drugs like BENICAR.

Key Takeaways

• The US patent expiration in 2018 caused a sharp decline in BENICAR sales.
• Generic competition dominates sales, reducing revenue for the original brand.
• Market share remains constrained by prescriber preferences and cost considerations.
• The future sales trajectory depends on external factors such as pipeline developments, brand differentiation, and competitive dynamics.
• The global antihypertensive market will continue growing modestly, but BENICAR's share will likely stay small absent new formulations or indications.

FAQs

1. How does BENICAR compare to other ARBs in efficacy?
BENICAR has similar efficacy to other ARBs like losartan and valsartan, with clinical trials indicating comparable blood pressure reductions. However, prescriber preferences and formulary inclusion often favor other agents.

2. What regulatory risks does BENICAR face?
Risks include potential reclassification of hypertension medications, price regulation policies, and any future patent litigation or exclusivity extensions.

3. How significant is BENICAR in emerging markets?
In regions like Southeast Asia and Latin America, BENICAR retains some market share due to lower cost and existing supply chains. However, local generics increasingly replace branded drugs.

4. Are there ongoing clinical trials for BENICAR?
There are no notable current clinical trials evaluating new indications for BENICAR. Research focus has shifted to combination therapies and novel agents.

5. What strategic moves can sustain BENICAR’s market position?
Developing fixed-dose combinations, pursuing new indications, or differentiating through formulation improvements can extend its lifecycle.

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References

[1] Market research reports and industry analytics, 2023.