Olmesartan medoxomil - Generic Drug Details

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

Olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Cosette, Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Inventia, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Prinston Inc, Qilu, Rising, Sandoz, Sciegen Pharms Inc, Sunshine, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for olmesartan medoxomil. Twenty-nine suppliers are listed for this compound.

Summary for olmesartan medoxomil

US Patents:	0
Tradenames:	2
Applicants:	25
NDAs:	25
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	80
Patent Applications:	5,595
Drug Prices:	Drug price trends for olmesartan medoxomil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olmesartan medoxomil
What excipients (inactive ingredients) are in olmesartan medoxomil?	olmesartan medoxomil excipients list
DailyMed Link:	olmesartan medoxomil at DailyMed

See drug prices for olmesartan medoxomil

Recent Clinical Trials for olmesartan medoxomil

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

Sponsor	Phase
EMS	Phase 3
Seoul National University Bundang Hospital	Phase 4
Shenzhen People's Hospital	Phase 2

See all olmesartan medoxomil clinical trials

Pharmacology for olmesartan medoxomil

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for olmesartan medoxomil

Angiotensin II Type 1 Receptor Blockers

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for olmesartan medoxomil

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 OLMESARTAN MEDOXOMIL

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 olmesartan medoxomil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	207480-003	Jul 11, 2023		DISCN	No	No
Umedica	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	207135-002	Jul 18, 2019	AB	RX	No	No
Teva Pharms Usa	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	091079-002	Apr 24, 2017		DISCN	No	No
Torrent	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	202375-003	Apr 24, 2017		DISCN	No	No
Amneal	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	207480-002	Jul 11, 2023		DISCN	No	No
Accord Hlthcare	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	207662-001	Apr 24, 2017	AB	RX	No	No
Chartwell Rx	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	206227-003	Jan 25, 2024	AB	RX	No	No

Expired US Patents for olmesartan medoxomil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002

Olmesartan medoxomil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Olmesartan Medoxomil

Market Introduction

Olmesartan medoxomil, a prodrug that converts to olmesartan in the gastrointestinal tract, is an angiotensin II receptor blocker (ARB) used primarily to treat hypertension, kidney failure, and certain cases of heart attacks. It works by relaxing blood vessels, allowing blood to flow more easily[1][5].

Key Market Drivers

The market for olmesartan medoxomil is driven by several key factors:

• Rising Prevalence of Cardiovascular Disorders: The increasing incidence of hypertension, stroke, and cardiac arrest globally is a significant driver. As the population ages and lifestyle-related diseases become more common, the demand for effective antihypertensive medications like olmesartan medoxomil is expected to rise[1][4].
• Increasing Geriatric Population: The growing number of elderly individuals, who are more prone to cardiovascular diseases, is another major driver. This demographic shift is expected to fuel market growth during the forecast period[1].

Market Restraints

Despite the positive drivers, there are several restraints that could impact the market:

• Potential Side Effects: Olmesartan medoxomil is associated with side effects such as dizziness, muscle weakness, shortness of breath, and allergic reactions. These adverse effects can deter patients and healthcare providers, potentially restraining market growth[1][5].
• Generic Competition: The entry of generic versions of olmesartan medoxomil can lead to price erosion and reduced profit margins for branded products, posing a significant challenge to market growth[4].

Market Segmentation

The olmesartan medoxomil market is segmented based on product and application:

• Product Segmentation: The market is segmented into 20 mg and 40 mg tablets. These dosages are tailored to meet the varying needs of patients, with the option to increase the dose from 20 mg to 40 mg based on the patient's response[1].
• Application Segmentation: The primary applications include hypertension, kidney failure, and heart attacks. The drug can be used as monotherapy or in combination with other antihypertensive medications to achieve better blood pressure control[1][5].

Regional Framework

The market is analyzed across several key regions:

• North America: This region is a significant market due to its robust healthcare infrastructure, high prevalence of hypertension, and strong regulatory support. The United States and Canada are major contributors to the market growth in this region[4].
• Europe: Europe also represents a substantial market, driven by the high incidence of cardiovascular diseases and the presence of well-established pharmaceutical companies.
• Asia-Pacific: This region is the fastest-growing market, 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[4].
• Middle East and Africa (MEA) and South & Central America: These regions also show potential for growth, although they are currently smaller markets compared to North America, Europe, and Asia-Pacific.

Financial Trajectory

The financial outlook for the olmesartan medoxomil market is promising:

• Market Size and Growth: The market is expected to witness high growth during the forecast period from 2024 to 2031. The global market size is projected to increase significantly, driven by the rising demand for antihypertensive medications[1][4].
• CAGR: The compound annual growth rate (CAGR) for the olmesartan medoxomil market is expected to be substantial, reflecting the increasing need for effective blood pressure management solutions[1].
• Revenue Forecast: The revenue forecast indicates a steady increase, with the market size expected to reach significant figures by 2031. For example, the Amlodipine and Olmesartan market, which includes olmesartan medoxomil, was valued at USD 597.95 million in 2023 and is projected to reach USD 824.65 million by 2031, growing at a CAGR of 4.10%[4].

Competitive Landscape

The market for olmesartan medoxomil is competitive, with several key players:

• Key Players: Companies such as Daiichi Sankyo, Aurobindo Pharma Limited, and Hikma Pharmaceuticals are significant players in the market. These companies are focusing on both organic and inorganic growth strategies, including product launches, acquisitions, and partnerships to expand their market share[1][4].
• Generic Versions: The launch of generic versions by companies like Aurobindo Pharma Limited and Hikma Pharmaceuticals is expected to increase market competition and provide more affordable options for patients[4].

PEST Analysis

The market is influenced by various political, economic, social, and technological factors:

• Political Factors: Regulatory support and favorable reimbursement policies in regions like North America are crucial for market growth.
• Economic Factors: Economic stability and healthcare budget constraints can affect drug pricing and reimbursement policies, impacting market access.
• Social Factors: Increasing awareness of health and wellness, particularly in the Asia-Pacific region, drives the demand for antihypertensive medications.
• Technological Factors: Advancements in drug formulations and the development of combination therapies are expected to improve patient outcomes and drive market growth[1][4].

Key Takeaways

• The olmesartan medoxomil market is driven by the rising prevalence of cardiovascular disorders and an increasing geriatric population.
• The market is segmented by product and application, with 20 mg and 40 mg tablets being the primary products.
• North America, Europe, and Asia-Pacific are key regions driving market growth.
• The market faces restraints such as potential side effects and generic competition.
• The financial trajectory indicates a significant growth potential, with a substantial CAGR and increasing revenue forecast.

Frequently Asked Questions (FAQs)

Q: What is olmesartan medoxomil used for? A: Olmesartan medoxomil is used to treat hypertension, kidney failure, and certain cases of heart attacks by relaxing blood vessels and improving blood flow[1][5].

Q: What are the common side effects of olmesartan medoxomil? A: Common side effects include dizziness, muscle weakness, shortness of breath, and allergic reactions. Long-term use can also lead to sprue enteropathy-like symptoms[1][5].

Q: Which regions are driving the growth of the olmesartan medoxomil market? A: North America, Europe, and the Asia-Pacific region are the key drivers of market growth, with the Asia-Pacific region being the fastest-growing market[1][4].

Q: How does the competitive landscape of the olmesartan medoxomil market look? A: The market is competitive with key players like Daiichi Sankyo, Aurobindo Pharma Limited, and Hikma Pharmaceuticals. Generic versions are also entering the market, increasing competition[1][4].

Q: What is the financial outlook for the olmesartan medoxomil market? A: The market is expected to grow significantly, with a substantial CAGR and increasing revenue forecast. The Amlodipine and Olmesartan market, for example, is projected to reach USD 824.65 million by 2031[1][4].

Cited Sources:

1. The Insight Partners - Olmesartan Medoxomil Market SWOT Analysis by 2031
2. FDA - sNDA 21-286 Olmesartan medoxomil (Benicar®)
3. GlobalData - Net Present Value Model: Olmesartan Medoxomil
4. Verified Market Research - Amlodipine And Olmesartan Market Size, Share, Trends & Forecast
5. NCBI Bookshelf - Olmesartan - StatPearls