AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - Generic Drug Details

What are the generic sources for amlodipine besylate; olmesartan medoxomil and what is the scope of freedom to operate?

Amlodipine besylate; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Micro Labs, Sciegen Pharms Inc, Teva Pharms Usa, Torrent, Zydus Pharms, and Cosette, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	18
Clinical Trials:	4
DailyMed Link:	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL at DailyMed

Recent Clinical Trials for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Daiichi Sankyo, Inc.	Phase 3
Daiichi Sankyo Inc.	Phase 3
Daiichi Sankyo Inc.	Phase 4

See all AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Applicant	Application No.	Strength	Dosage Form
		10MG/40MG	TABLET; ORAL
		10MG/20MG	TABLET; ORAL
		5MG/40MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209042-003	Aug 14, 2017	AB	RX	No	No
Alkem Labs Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209042-002	Aug 14, 2017	AB	RX	No	No
Accord Hlthcare Inc	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209600-004	Aug 30, 2018		DISCN	No	No

Expired US Patents for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Olmesartan Medoxomil

Introduction to Amlodipine Besylate and Olmesartan Medoxomil

Amlodipine besylate and olmesartan medoxomil are two medications commonly combined 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 combination is widely used for patients who require multiple therapies to effectively manage their blood pressure.

Market Size and Forecast

The market for amlodipine and olmesartan is projected to grow significantly over the next few years. As of 2023, the market size was valued at USD 597.95 million and is expected 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 rising global incidence of hypertension and cardiovascular diseases is a major driver of the market. According to the World Health Organization (WHO), approximately 1.28 million adults in low and middle-income countries suffer from hypertension, with many unaware of their condition[3].

Advancements in Drug Formulations

Advancements in pharmaceutical formulations, such as extended-release versions and combination therapies, enhance patient compliance and accessibility. These innovations are crucial in sustaining market growth as they offer better treatment outcomes and convenience for patients[3].

Regulatory Support and Reimbursement Policies

Strong regulatory support and favorable reimbursement policies, particularly in regions like North America, encourage the adoption of innovative healthcare solutions. This support is instrumental in driving the market forward by ensuring broad access to these medications[1].

Regional Analysis

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 contribute significantly to market growth due to the presence of well-established pharmaceutical companies and advanced research and development facilities. Approximately 47% of adults in the U.S. have hypertension, underscoring the high demand for effective antihypertensive medications[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for amlodipine and olmesartan. Rapid urbanization, rising disposable incomes, and increasing awareness of health and wellness among consumers are key factors driving this growth. Countries like India and China are experiencing significant growth due to the rising prevalence of lifestyle-related diseases, including hypertension. Government initiatives aimed at promoting hypertension awareness and improving access to healthcare services further boost demand in this region[1].

Market Segmentation

By Application

The global amlodipine and olmesartan market is segmented into hospitals and drug stores. The hospitals segment dominates due to comprehensive patient management capabilities and the availability of specialized medical personnel. However, the drug stores segment is the fastest-growing, driven by increasing patient self-management of chronic conditions and a growing preference for over-the-counter access to antihypertensive medications[1].

Challenges

Generic Competition

The entry of generic versions of amlodipine and olmesartan poses a significant challenge to market growth. Generic alternatives can lead to price erosion and reduced profit margins for branded products, affecting the financial trajectory of the market[1].

Adverse Drug Reactions

Potential side effects associated with amlodipine and olmesartan, such as dizziness, swelling, or gastrointestinal issues, may deter some patients from continuing their prescribed treatment. This can impact market demand and the overall financial performance of the medications[1].

Regulatory Hurdles

The approval process for new formulations and combination therapies can be lengthy and complex, delaying the introduction of innovative products in the market and limiting growth opportunities. This regulatory complexity can hinder the financial growth of the market by slowing down the introduction of new and improved treatments[1].

Economic Factors

Economic instability and healthcare budget constraints can affect drug pricing and reimbursement policies, limiting access to essential medications for patients, particularly in low- and middle-income countries. These economic factors can significantly impact the market's financial trajectory by reducing demand and affecting pricing strategies[1].

Clinical Efficacy and Tolerability

Studies have shown that the combination of amlodipine and olmesartan is highly effective and well-tolerated in patients with hypertension. A multicenter, randomized, double-blind study demonstrated that combination therapy resulted in significant reductions in both systolic and diastolic blood pressure compared to monotherapy. The study also highlighted that the combination was generally well-tolerated, with no unexpected safety concerns emerging[2].

Market Players and Recent Developments

Aurobindo Pharma Limited

In May 2024, Aurobindo Pharma Limited received final approval from the U.S. Food and Drug Administration (FDA) for its amlodipine and olmesartan medoxomil tablets in multiple dosages. This product is recognized as bioequivalent to Daiichi Sankyo’s Azor®, catering to a significant market segment[1].

Hikma Pharmaceuticals

In August 2024, Hikma Pharmaceuticals successfully launched its generic version of amlodipine and olmesartan in the U.S. market. This move allows Hikma to expand its generic product line, leveraging its existing distribution channels and manufacturing capabilities[1].

Financial Trajectory

The financial trajectory of the amlodipine and olmesartan market is expected to be positive, driven by the increasing demand for effective antihypertensive medications. Here are some key financial indicators:

• Market Size: Projected to reach USD 824.65 million by 2031 from USD 597.95 million in 2023, growing at a CAGR of 4.10% from 2024 to 2031[1].
• Revenue Growth: The market is expected to see steady revenue growth due to the rising prevalence of hypertension and the increasing adoption of combination therapies.
• Profit Margins: Despite challenges from generic competition, pharmaceutical companies can maintain profit margins by focusing on differentiating their products through improved formulations and combination therapies[3].

Key Takeaways

• The amlodipine and olmesartan market is driven by the increasing prevalence of hypertension and advancements in drug formulations.
• North America and the Asia Pacific are key regions driving market growth.
• Generic competition, adverse drug reactions, and regulatory hurdles are significant challenges.
• The combination of amlodipine and olmesartan is clinically effective and well-tolerated.
• Market players are expanding their product lines through FDA approvals and strategic launches.

FAQs

What is the primary use of amlodipine and olmesartan?

Amlodipine and olmesartan are primarily used to treat hypertension (high blood pressure) by combining a calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (olmesartan)[1].

What are the key drivers of the amlodipine and olmesartan market?

The key drivers include the increasing prevalence of hypertension, advancements in drug formulations, and strong regulatory support and reimbursement policies[1][3].

Which regions are leading the market growth?

North America is the dominant region, while the Asia Pacific is the fastest-growing region due to rapid urbanization and increasing awareness of health and wellness[1].

What are the major challenges facing the market?

Generic competition, adverse drug reactions, regulatory hurdles, and economic factors are significant challenges to market growth[1].

How effective is the combination of amlodipine and olmesartan?

Clinical studies have shown that the combination of amlodipine and olmesartan is highly effective and well-tolerated, resulting in significant reductions in both systolic and diastolic blood pressure[2].

Sources

1. Verified Market Research: Amlodipine And Olmesartan Market Size, Share, Trends & Forecast.
2. PubMed: The combination of olmesartan medoxomil and amlodipine besylate.
3. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031].
4. Oxford Academic: An efficacy evaluation of olmesartan medoxomil/hydrochlorothiazide.
5. Drugs.com: Amlodipine and Olmesartan Medoxomil: Package Insert.