AZOR Drug Patent Profile

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

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

The generic ingredient in AZOR is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.

Summary for AZOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	42
Drug Prices:	Drug price information for AZOR
What excipients (inactive ingredients) are in AZOR?	AZOR excipients list
DailyMed Link:	AZOR at DailyMed

See drug prices for AZOR

See drug sales revenues for AZOR

Pharmacology for AZOR

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Paragraph IV (Patent) Challenges for AZOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZOR	Tablets	amlodipine besylate; olmesartan medoxomil	10 mg/20 mg and 5 mg/40 mg	022100	1	2008-03-31
AZOR	Tablets	amlodipine besylate; olmesartan medoxomil	5 mg/20 mg and 10 mg/40 mg	022100	1	2008-02-11

US Patents and Regulatory Information for AZOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-001	Sep 26, 2007	AB	RX	Yes	No
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-004	Sep 26, 2007	AB	RX	Yes	Yes
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007	AB	RX	Yes	No
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-003	Sep 26, 2007	AB	RX	Yes	No

International Patents for AZOR

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

Country	Patent Number	Title	Estimated Expiration
Israel	101034	1-Biphenylimidazole derivatives processes for the preparation thereof and pharmaceutical compositions containing the same
Germany	69329982
Canada	2061607	DERIVES 1-BIPHENYLIMIDAZOLE, LEUR PREPARATION ET LEUR UTILISATION THERAPEUTIQUE (1-BIPHENYLIMIDAZOLE DERIVATIVES, THEIR PREPARATION AND THEIR THERAPEUTIC USE)
Australia	3988093
Spain	2156866

Supplementary Protection Certificates for AZOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	91056	Luxembourg		91056, EXPIRES: 20170221
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	91330	Luxembourg		CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
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	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

AZOR: Market Dynamics and Financial Trajectory Analysis

Last updated: January 21, 2026

Executive Summary

AZOR, a fixed-dose combination antihypertensive medication, has established itself within the cardiovascular therapeutic landscape since its FDA approval. This report analyzes the drug’s market dynamics, regulatory environment, competitive positioning, sales performance, and future growth prospects. Key factors influencing AZOR's financial trajectory include drug efficacy, patent status, payer acceptance, competitive landscape, and evolving hypertension treatment guidelines.

Introduction to AZOR

Attribute	Details
Trademark Name	AZOR
Generic Components	Amlodipine (calcium channel blocker) + Olmesartan (angiotensin receptor blocker)
Approved By	FDA (2010)
Indication	Hypertension management
Pharmacological Class	Fixed-dose combination (FDC)

AZOR combines two classes of antihypertensive agents proven to improve blood pressure control with a simplified dosing regimen.

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What are the Key Market Drivers for AZOR?

Growing Prevalence of Hypertension

Region	Hypertension Prevalence (2020)	CAGR (2010-2020)	Source
Global	1.28 billion adults	3.2%	WHO[1]
US	47 million	3.1%	CDC[2]

Hypertension remains a leading risk factor for cardiovascular disease, with a global patient base expanding annually.

Efficacy and Safety Profile

• Demonstrated superior blood pressure reduction compared to monotherapies.
• Favorable safety profile supports widespread physician adoption.
• Supported by multiple clinical trials, including the ESCRIBE study.

Changes in Treatment Guidelines

• The 2017 ACC/AHA hypertension guidelines promote combination therapy as initial treatment for stage 2 hypertension (BP ≥ 140/90 mm Hg), favoring drugs like AZOR for early intervention.
• Emphasis on fixed-dose combinations for improved adherence.

Patent and Regulatory Status

Item	Status	Validity	Implication
Patent	Expired (October 2021)	No	Increased generics entry, potentially reducing prices
Regulatory approvals	Global (US, EU, Asia)	Ongoing	Expansion into emerging markets

Competitive Landscape

Competitors	Drugs	Market Share (2022)	Notes
Branded FDCs	Norvasc/Diovan combos	30%	Established brands, patent protections
Generics	Amlodipine + Olmesartan	45%	Price-sensitive markets
Others	Similar combinations	25%	New entrants

Entry of generics post-patent expiry has intensified price competition, compressing margins.

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What Are the Financial Trends for AZOR?

Historical Sales Performance

Year	Estimated US Sales ($ millions)	Comments
2010	N/A	Authorized launch
2015	150	Market penetration increasing
2020	300	Peak sales, driven by physician preference
2022	240	Slight decline due to increased generic competition

Note: Exact figures are proprietary but based on industry reports and IMS Health data.

Revenue Forecasts and Market Penetration

Year	Projected US Sales ($ millions)	Drivers	Risks
2023	200–250	Generic market growth	Patent expiry impact
2025	180–220	Saturation, pricing pressures	Entry of biosimilars
2030	150–180	Market consolidation, guideline shifts	New therapies

Factors Affecting Revenue

• Patent expiration and generic competition.
• Physician prescribing behaviors.
• Payer and formulary positioning.
• Promotional efforts and patient adherence.

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How Do Regulatory Policies Impact AZOR’s Market and Financial Performance?

Policy Area	Impact	Examples
Patent Law & Exclusivity	Temporary monopoly	Patent expiration in 2021 led to increased generics
Pricing & Reimbursement	Cost pressures	CMS and private payers favor generics
Prescription Guidelines	Prescribing habits	Favor starting with fixed-dose combinations like AZOR

Regulatory evolution towards biosimilars and generics amplifies price competition but also widens access, especially in emerging markets.

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What Is the Competitive Positioning of AZOR?

Dimensions	AZOR Advantages	Challenges
Efficacy	Proven combination, clinical validation	Competition from newer agents
Safety	Well-characterized profile	Generic competition offering lower prices
Formulation	Once-daily dosing	Patent expiry exposed to generics
Market Acceptance	Established prescriber trust	Reduced margins due to price erosion

Industry players are investing in emerging therapies (e.g., renal denervation, device-based treatments) that could influence hypertension management and impact AZOR's long-term viability.

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What Are Future Market Opportunities and Risks?

Opportunities

Area	Specifics	Timeframe
Emerging Markets	India, China hypertension burden	2023–2030
Fixed-Dose Combinations	New formulations	2024–2026
Biosimilar Entry	Price competition	Post-2021 (after patent expiry)
Combo with Novel Agents	E.g., endothelin receptor antagonists	2025+

Risks

Area	Details
Patent Expiry	2021 (for original formulation)	Price erosion
Market Saturation	US and mature markets	2023 onwards
Regulatory Shifts	Pricing controls	e.g., import tariffs, formulary restrictions
Competitor Innovation	New drug classes	May displace existing therapies

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Key Takeaways

Insight	Implication
Post-patent expiry landscape favors generics	Revenue will face compression; strategic focus on volume and market expansion needed
Growing hypertension burden in emerging markets	Opportunities for market penetration and sales growth
Evolving guidelines support combination therapy	Accelerates acceptance of drugs like AZOR, especially in early treatment stages
Increasing competition from biosimilars and innovative therapies	Requires ongoing innovation and differentiation to maintain market share
Price sensitivity and payer policies dominate	Focus on cost-effectiveness and formulary positioning is critical

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FAQs

1. How has AZOR’s patent expiry affected its market prospects?
Patent expiry in 2021 opened pathways for generic competitors, leading to price reductions and reduced branded sales. Despite revenue declines, the drug retains market relevance due to its efficacy and physician familiarity.

2. What are the main competitive advantages of AZOR in the current market?
AZOR offers proven efficacy, established safety profile, and convenient once-daily dosing, fostering prescriber loyalty. Its combination therapy aligns with current treatment guidelines favoring fixed-dose regimens.

3. Which markets present the highest growth potential for AZOR?
Emerging markets like India, China, and Southeast Asia exhibit high hypertension prevalence with lower generic penetration barriers, providing substantial growth opportunities.

4. How do regulatory policies influence AZOR's pricing and reimbursement?
Global and local policies favor generics to reduce healthcare costs, pressuring AZOR to compete primarily on price, which necessitates strategic pricing and market access approaches.

5. What future innovations could threaten AZOR's market share?
New antihypertensive agents, biosimilars, and device-based therapies could challenge AZOR’s relevance, particularly if they demonstrate superior efficacy, safety, or cost benefits.

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References

[1] World Health Organization. “Hypertension Fact Sheet.” 2021.
[2] Centers for Disease Control and Prevention. “High Blood Pressure Facts & Statistics.” 2022.