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. Fifteen 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

Expired US Patents for AZOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-001	Sep 26, 2007	5,616,599*PED
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-004	Sep 26, 2007	5,616,599*PED
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-003	Sep 26, 2007	5,616,599*PED
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007	5,616,599*PED

International Patents for AZOR

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

Country	Patent Number	Title	Estimated Expiration
Japan	3461863
Japan	H0578328	BIPHENYLMETHYLIMIDAZOLE DERIVATIVE
Hong Kong	1011983
China	1065063
China	1085896
Japan	H0649036	IMIDAZOLE DERIVATIVE
Hungary	T60475

Supplementary Protection Certificates for AZOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C00503785/01	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
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	91847	Luxembourg		91847, EXPIRES: 20170221
0503785	C00503785/02	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
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
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AZOR

Last updated: July 28, 2025

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Introduction

AZOR, a combination antihypertensive medication comprising olmesartan medoxomil and amlodipine besylate, has established itself as a significant player in the cardiovascular therapeutics segment. Its positioning within the antihypertensive market is driven by evolving market dynamics, regulatory landscapes, and competitive innovations. This report examines AZOR’s market environment, analyzing key drivers, challenges, and projected financial performance trajectories to assist stakeholders in strategic decision-making.

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Product Overview and Regulatory Status

AZOR was developed and commercialized primarily by Daiichi Sankyo, targeting hypertension management, a condition with high prevalence globally. The drug’s combination therapy offers enhanced efficacy and patient compliance over monotherapies. Its regulatory approval spans multiple markets, including the United States, Europe, and Asia. The FDA initially approved AZOR in 2012, recognizing its safety and efficacy profile. The drug’s patent protection dynamics and biosimilar entries influence its market exclusivity and valuation over time.

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Market Dynamics

Global Hypertension Market Overview

The global hypertension therapeutics market is projected to expand at a compound annual growth rate (CAGR) of approximately 3.8% from 2023 to 2030, driven by increasing hypertension prevalence, aging populations, and expanding healthcare access in emerging markets [1]. As hypertension remains a primary risk factor for cardiovascular morbidity, demand for effective combination medications like AZOR continues to grow.

Key Drivers

• Prevalence and Demographics: The World Health Organization reports over 1.2 billion individuals globally with hypertension, with prevalence rising in low- and middle-income countries [2]. Aging populations further elevate demand for antihypertensive agents.

• Therapeutic Innovations: The shift toward fixed-dose combination therapies improves adherence and outcomes. AZOR’s combination of olmesartan (an ARB) and amlodipine (a calcium channel blocker) aligns well with current treatment guidelines favoring such regimens.

• Regulatory Approvals and Label Expansions: Ongoing approvals and expanded indications bolster AZOR’s market penetration. In some regions, regulatory bodies have approved generic equivalents, intensifying competition.

• Healthcare Infrastructure: Increased diagnosis rates and improved healthcare infrastructure facilitate prescriptions of combination therapies like AZOR.

Market Challenges

• Biosimilars and Generics: Patent expirations in several jurisdictions have led to generic equivalents entering the market, pressuring pricing and margins [3].

• Competitive Landscape: AZOR faces competition from other combination therapies, including losartan with amlodipine and valsartan-based combinations, which have comparable efficacy profiles.

• Pricing Pressure: Payers’ emphasis on cost-containment influences drug pricing, especially in countries adopting value-based care models.

• Regulatory and Patent Constraints: Patent cliffs and legal challenges for patent extensions could accelerate generic entry, impacting AZOR’s exclusivity period.

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Financial Trajectory Analysis

Historical Performance

Since its debut, AZOR has demonstrated steady sales growth driven by increased adoption in hypertensive patients. According to Daiichi Sankyo’s quarterly financial disclosures, AZOR contributed a significant share of the company’s cardiovascular segment revenues, with year-over-year growth averaging 5-7% prior to patent expiry concerns.

Forecasting Future Revenue

The financial trajectory for AZOR hinges on key factors:

• Market Penetration and Patient Adherence: As awareness increases, prescriptions are expected to grow, especially in emerging markets where hypertension awareness campaigns are active.

• Patent and Patent Expiry Outlook: In jurisdictions where patent protection is nearing expiration (typically 10-12 years post-launch), revenues may decline unless mitigated by formulations or new indications.

• Generic and Biosimilar Competition: Entry of generics could decrease average selling prices (ASPs) by 30-50%, compounding revenue declines unless offset by volume increases.

• Pricing Strategies and Payer Dynamics: Price negotiations, discounts, and formulary placements directly influence revenue streams.

Utilizing population-based models and sales data from comparable combination drugs, analysts project AZOR’s global revenues to peak at approximately USD 600-700 million by 2025, followed by stabilization or gradual decline contingent on patent protections and competitive actions [4].

Profitability Outlook

Gross margins are anticipated to decline upon generic entry, but strategic volume increases and cost efficiencies could sustain profitability. R&D investments into next-generation formulations or novel indications could also provide upside potential.

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Strategic Considerations

• Patent Life Management: Patent defenses and strategic patenting of formulations or delivery mechanisms are critical in delaying generic displacements.

• Lifecycle Extension: Development of new dosing options or combination formulations can prolong AZOR’s market relevance.

• Regional Expansion: Focused efforts on emerging markets can offset stagnation in mature regions, given their large hypertensive populations.

• Partnerships and Alliances: Collaborations with regional distributors can facilitate market access and volume growth.

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Conclusion

AZOR’s market dynamics are intricately linked to hypertension prevalence, innovation in therapeutic regimens, and regulatory factors. While current growth is robust, impending patent expirations and competition pose risks to future revenue. Strategic maneuvers—such as lifecycle management, geographic expansion, and pipeline development—are essential for optimizing its financial trajectory.

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Key Takeaways

• The global demand for effective hypertension treatments supports AZOR’s continued relevance; however, patent expiration and biosimilar competition threaten profitability.

• Market expansion in emerging economies presents significant growth opportunities, leveraging increasing hypertension awareness and healthcare infrastructure.

• Price pressures and formulary decisions necessitate strategic pricing and regulatory agility to sustain margins.

• Lifecycle management initiatives, including new indications and formulations, can mitigate revenue decline post-patent expiry.

• Investors and stakeholders should monitor patent statuses, competitive dynamics, and regional market policies to navigate AZOR’s financial outlook effectively.

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FAQs

1. What is AZOR, and how does it differ from other antihypertensive drugs?
   AZOR is a fixed-dose combination of olmesartan medoxomil and amlodipine besylate, offering synergistic blood pressure reduction and improved patient adherence compared to monotherapies.

2. When are patent protections for AZOR expected to expire?
   Patent protections typically extend around 10-12 years post-launch; for AZOR, this is projected around 2024–2026 in major markets, after which generic competitors may enter.

3. What are the primary factors influencing AZOR’s revenue growth?
   Factors include hypertension prevalence, regional adoption rates, patent status, competitive generics, and formulary placements.

4. How might biosimilars impact AZOR’s market share?
   While AZOR is a small-molecule drug and not a biosimilar, generic entry will likely reduce prices and market share unless countered with lifecycle strategies.

5. Are there any new developments or formulations of AZOR in pipeline?
   Currently, no publicly announced new formulations are available; however, ongoing research into novel antihypertensive combinations might offer future opportunities.

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References

[1] MarketWatch. "Hypertension Therapeutics Market Forecast," 2023.
[2] WHO. "Hypertension," 2022.
[3] IQVIA. "Generic Drug Trends," 2022.
[4] Deloitte. "Pharmaceutical Market Outlook," 2023.