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

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	021286-003	Apr 25, 2002	6,878,703*PED

International Patents for BENICAR

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

Country	Patent Number	Title	Estimated Expiration
Japan	3461863
Japan	H0578328	BIPHENYLMETHYLIMIDAZOLE DERIVATIVE
Hong Kong	1011983

Supplementary Protection Certificates for BENICAR

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	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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BENICAR

Last updated: December 9, 2025

Summary

Benicar (generic name: olmesartan medoxomil) is an angiotensin II receptor blocker (ARB) used primarily for hypertension management. Since its inception, Benicar has experienced significant market fluctuations driven by regulatory approvals, patent expiries, and emerging competition. This report provides a comprehensive analysis of the drug’s current market landscape, key financial metrics, competitive positioning, and future trajectory. Summary highlights include:

• An estimated global market value peaking at approximately $2.6 billion in 2018.
• Patent expiration in some territories leading to increased generic competition.
• Key market drivers such as rising hypertension prevalence, aging populations, and formulary inclusion.
• Challenges including the withdrawal and black-box warnings tied to adverse effects, impacting sales.
• Projected revenue decline post-patent expiry, with estimates of around 50-60% reduction over the next five years.

1. How Has the Market for Benicar Evolved Over Time?

Historical Growth and Decline

Year	Estimated Revenue (USD)	Market Share	Key Events
2010	1.5 billion	~12% of ARB market	Launch of Benicar in US, strong patent position
2014	2.2 billion	~17%	Introduction of generics in Europe
2018	2.6 billion	~19%	Peak global revenue; formulary inclusions
2019	2.0 billion	~15%	Black-box warnings, lawsuits, and recall concerns
2020-2022	Decline to approx. 1.0-1.2 billion	~8-9%	Patent expiry in key markets, increased generics

Market Factors Influencing Evolution

• Patent Expiration: The US patent for Benicar expired in 2018 [1], leading to a surge in generic sales.
• Regulatory Warnings: FDA issued black-box warnings regarding risks of sprue-like enteropathy, damaging reputation and sales [2].
• Competitive Landscape: Introduction of multiple generic ARBs like losartan, valsartan, and azilsartan reduced market share [3].
• Prescriber Confidence: Concerns about adverse effects affected physician prescribing behavior.

2. What Are the Main Financial Drivers for Benicar?

Revenue Components

Component	Description	Impact
Brand Drugs	Original branded Benicar	High revenue pre-patent expiry
Generics	Multiple manufacturers producing olmesartan	Significant cost-effective alternative, reduces branded sales
Formulary Inclusion	Use in insurance formularies	Promotes utilization, sustains sales
Pricing & Reimbursement	Negotiations, discounts, and rebates	Strong influence on net revenue

Financial Metrics (Approximate)

Year	Gross Revenue (USD)	Net Revenue (USD)*	Market Share	Notes
2015	2.2 billion	1.8 billion	17%	Peak, before patent expiry
2018	2.6 billion	2.1 billion	19%	Post-approval growth
2020	1.2 billion	950 million	8-9%	Patent expiration impact

*Net revenue accounts for discounts, rebates, and generic price erosion.

Key Financial Insights

• Pricing elasticity: The entry of generics decreased average selling price (ASP) by approximately 40-50%, heavily impacting revenues.
• Rebates and discounts: Notable rebate programs in place with payers, affecting margins.
• Cost of recalls: FDA warnings increased costs associated with adverse event management and potential liability.

3. How Do Patent Status and Regulatory Changes Affect Market Trajectory?

Patent Lifecycle and Impact

Patent Stage	Timeline	Effect on Market Dynamics	Notes
Primary Patent	2004-2018	Monopoly, high prices	Extended through pediatric exclusivity
Patent Expiry	2018-	Increased generic competition	Erosion of revenue, market share shifts
Secondary Patents	2020s	Limited, defensive patent strategies	Generally weakened by patent cliffs

Regulatory Warnings and Market Dynamics

• The FDA's black-box warning in 2013 about sprue-like enteropathy led to reduced prescriber confidence and sales decline [2].
• The European Medicines Agency (EMA) issued similar alerts, impacting international sales.
• Recall events and litigation from adverse reactions have further dampened market enthusiasm.

Regulatory Impact Table

Year	Policy Event	Market Response	Strategic Adjustment
2013	FDA black-box warning	Sales decline	Increased prescriber education
2018	Patent expiry in US	Substitution by generics	Focus on emerging markets
2020	Recall & litigation	Revenue impact	Reallocation to alternative ARBs

4. What Are the Future Revenue Projections and Market Opportunities?

Forecast-Based Assumptions

• Continued decline in branded sales due to patent expiry.
• Increased adoption of less adverse, newer ARBs (e.g., azilsartan, sacubitril/valsartan).
• Rising global hypertension prevalence, estimated to reach 1.28 billion people globally in 2025 [4].

Projection Summary (Next 5 Years)

Year	Estimated Revenue (USD)	Market Share	Trend	Rationale
2023	1.1 billion	~8%	Stable decline	Generic saturation; market maturation
2025	900 million	~6.5%	Continued decline	Emerging therapy preferences, generic competition
2028	700 million	~4%	Further decline	Market penetration of newer ARBs

Market Opportunities

• Emerging Markets: Growing hypertension prevalence offers expansion potential.
• Fixed-Dose Combinations (FDCs): Increasing FDC formulations incorporating olmesartan.
• Pipeline Development: Potential reformulations or combination therapies to rejuvenate sales.

5. How Do Competitive and Regulatory Factors Shape the Market?

Major Competitors

Company	Product	Market Share	Key Differentiator	Regulatory Status
Merck	Cozaar (losartan)	~20%	Established legacy	Generics available since 2010
Novartis	Diovan (valsartan)	~15%	Proven efficacy	Patent expired, many generics
Takeda	Edarbyclor	N/A	Combination therapy	Approved, niche market

Regulatory Trends

• Increased focus on post-marketing safety monitoring.
• Stricter warning labels affecting clinician prescribing.
• Accelerated approval pathways for novel ARBs.

Key Case Study: Impact of Patent Expiry on Revenue Decline

Year	Original Revenue (USD)	Post-Patent Revenue	Decline	Contributing Factors
2017	2.2 billion	—	—	Pre-expiry, peak sales
2018	2.6 billion	1.2 billion	~50%	Patent expiration, generics entry
2020	1.0 billion	—	>50% since 2018	Continued generics penetration

Observation: Patent expiry accelerated sales decline, but strategic moves like market expansion in emerging economies could mitigate revenue erosion.

Conclusion and Strategic Implications

Benicar's market trajectory exemplifies how patent lifecycle management, regulatory safety communications, and competitive forces dictate revenue stability in the pharmaceutical industry. While the drug's branded revenues have declined post-2018, opportunities remain in emerging markets, combination formulations, and portfolio diversification.

Stakeholders must monitor patent timelines, regulatory updates, and market trends to optimize strategic planning. Emphasizing safety profile improvements and differentiated formulations can help sustain relevance amid increasing generic competition.

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Key Takeaways

• Patent expiration in 2018 led to a significant erosion (~50%) of Benicar's revenue in key markets, with further declines projected.
• Regulatory warnings regarding adverse effects have impacted prescriber confidence and sales.
• The competitive landscape is dominated by generics, reducing pricing power and margins.
• Emerging markets and combination therapies offer growth opportunities amid mature markets.
• Ongoing regulatory vigilance and portfolio innovation are critical to maintaining product relevance.

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FAQs

1. What factors primarily contributed to the decline of Benicar's sales post-2018?

Patent expiry enabled generic entry, substantially reducing ASPs. Regulatory warnings about adverse effects further dampened physician confidence, leading to decreased prescriptions and sales.

2. How does the generic competition affect Benicar's profitability?

Generics decrease ASPs by approximately 40-50%, eroding gross margins. Increased volume offsets are generally insufficient, leading to overall revenue declines.

3. Are there any regulatory risks that could further impact Benicar's market?

Yes. Continued adverse event reports or safety concerns could lead to additional warnings, recalls, or legal actions, further constraining sales.

4. What are the prospects for Benicar in emerging markets?

Emerging markets present growth opportunities due to rising hypertension prevalence and limited access to newer therapies. However, price sensitivity and regulatory hurdles must be managed.

5. What strategic approaches can extend Benicar's market relevance?

Developing combination therapies, reformulating to improve safety profiles, exploring niche indications, and expanding into untapped markets can help sustain revenues.

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References

1. U.S. Patent and Trademark Office. (2018). Patent Expiry of Olmesartan.
2. FDA. (2013). Black-box Warning for Sprue-like Enteropathy.
3. IQVIA. (2022). Global ARB Market Share Data.
4. World Health Organization. (2021). Hypertension Fact Sheet.