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. Eighteen 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:	3
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
China	1045770
Norway	2011013
Luxembourg	91056
Hungary	9200578
Hong Kong	1011361
Norway	2006012

Supplementary Protection Certificates for AZOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	91571	Luxembourg		91571, EXPIRES: 20170221
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
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	C00503785/02	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114

AZOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azor (Amlodipine and Olmesartan)

Introduction to Azor

Azor, a combination medication of amlodipine and olmesartan, is widely used to treat hypertension (high blood pressure). Amlodipine, a calcium channel blocker, relaxes blood vessels to improve blood flow, while olmesartan, an angiotensin II receptor blocker, prevents blood vessel constriction. This dual-action approach makes Azor an effective treatment for patients requiring multiple therapies to manage their blood pressure.

Market Size and Forecast

The Amlodipine and Olmesartan market, which includes Azor, was valued at USD 597.95 million in 2023 and is projected to reach USD 824.65 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.10% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Hypertension

The global incidence of cardiovascular diseases, including hypertension, is on the rise. This trend is expected to drive the demand for antihypertensive medications like Azor. In regions such as North America and the Asia Pacific, the high prevalence of hypertension among the adult population is a significant driver of market growth[1].

Advancements in Drug Formulations

Advancements in drug formulations and the increased emphasis on combination therapies are expected to enhance patient outcomes, thereby boosting the demand for Azor. New formulations and generic versions entering the market are likely to cater to a broader patient base[1].

Regulatory and Public Health Initiatives

Strong regulatory support and favorable reimbursement policies in regions like North America encourage the adoption of innovative healthcare solutions, including Azor. Public health initiatives aimed at reducing cardiovascular risks also contribute to the growing demand for this medication[1].

Market Challenges

Generic Competition

The entry of generic versions of Azor poses a significant challenge to the market growth of branded products. Generic alternatives, such as those launched by Aurobindo Pharma Limited and Hikma Pharmaceuticals, can lead to price erosion and reduced profit margins for branded products[1].

Adverse Drug Reactions

Potential side effects associated with Azor, such as dizziness, swelling, or gastrointestinal issues, may deter some patients from continuing their prescribed treatment. This can impact market demand and patient adherence to the medication[1].

Regulatory Hurdles

The lengthy and complex approval process for new formulations and combination therapies can delay the introduction of innovative products in the market, limiting growth opportunities[1].

Economic Factors

Economic instability and healthcare budget constraints can affect drug pricing and reimbursement policies, limiting access to essential medications like Azor, particularly in low- and middle-income countries[1].

Regional Market Dynamics

North America

North America is the dominant region in the Amlodipine and Olmesartan market, driven by a robust healthcare infrastructure, high prevalence of hypertension, and increased awareness of cardiovascular diseases. The United States and Canada are key contributors to market growth due to the presence of well-established pharmaceutical companies and advanced research and development facilities[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for Azor, driven by rapid urbanization, rising disposable incomes, and increasing awareness of health and wellness. Countries like India and China are experiencing significant growth due to the rising prevalence of lifestyle-related diseases, including hypertension[1].

Application Segments

Hospitals

The hospitals segment dominates the market due to comprehensive patient management capabilities and the availability of specialized medical personnel to prescribe and administer Azor. Hospitals play a crucial role in the initial treatment and stabilization of patients with hypertension[1].

Drug Stores

The drug stores segment is the fastest-growing segment, driven by increasing patient self-management of chronic conditions and a growing preference for over-the-counter access to antihypertensive medications[1].

Financial Impact of Generic Versions

The launch of generic versions of Azor, such as those by Aurobindo Pharma Limited and Hikma Pharmaceuticals, is expected to significantly impact the financial trajectory of the branded product. Generic versions can reduce the market share and revenue of branded Azor, as they offer lower-priced alternatives. For example, the generic version of Azor can cost as low as $98.51 for 30 tablets, compared to the branded version which can cost around $410 for the same quantity[1][5].

Industry Expert Insights

Industry experts highlight the importance of managing hypertension effectively to reduce cardiovascular risks. According to the American Heart Association, there is a growing emphasis on managing hypertension, which has resulted in a surge in prescriptions for medications like Azor[1].

Illustrative Statistics

• Approximately 47% of adults in the U.S. have hypertension, underscoring the high demand for effective antihypertensive medications like Azor[1].
• The World Health Organization (WHO) estimates that hypertension affects about 30% of the adult population in countries like India and China, highlighting a vast potential customer base for these medications[1].

Key Takeaways

• The Amlodipine and Olmesartan market, including Azor, is projected to grow at a CAGR of 4.10% from 2024 to 2031.
• The market is driven by the increasing prevalence of hypertension, advancements in drug formulations, and strong regulatory support.
• Generic competition, adverse drug reactions, regulatory hurdles, and economic factors pose significant challenges to market growth.
• North America and the Asia Pacific are key regions driving market growth.
• Hospitals and drug stores are the primary application segments, with hospitals dominating due to comprehensive patient management.

FAQs

1. What is Azor used for?

Azor is used to treat hypertension (high blood pressure) by combining amlodipine, a calcium channel blocker, and olmesartan, an angiotensin II receptor blocker.

2. What is the projected market size of Azor by 2031?

The Amlodipine and Olmesartan market, which includes Azor, is projected to reach USD 824.65 million by 2031[1].

3. What are the main challenges facing the Azor market?

The main challenges include generic competition, adverse drug reactions, regulatory hurdles, and economic factors such as healthcare budget constraints[1].

4. Which regions are driving the growth of the Azor market?

North America and the Asia Pacific are the key regions driving market growth, with North America being the dominant region and the Asia Pacific being the fastest-growing region[1].

5. How do generic versions impact the Azor market?

Generic versions of Azor can lead to price erosion and reduced profit margins for branded products, as they offer lower-priced alternatives to patients[1][5].

Cited Sources:

1. Verified Market Research: Amlodipine And Olmesartan Market Size, Share, Trends & Forecast.
2. Daiichi Sankyo: Annual Report.
3. ASPE: Explaining the Growth in Prescription Drug Spending: A Review of Recent Studies.
4. iHealthcareAnalyst: Antihypertensive Drugs Market and Forecast 2024-2031.
5. Drugs.com: Azor Prices, Coupons, Copay Cards & Patient Assistance.