You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

AMLODIPINE AND OLMESARTAN MEDOXOMIL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Amlodipine And Olmesartan Medoxomil patents expire, and what generic alternatives are available?

Amlodipine And Olmesartan Medoxomil is a drug 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, and Zydus Pharms. and is included in thirteen NDAs.

The generic ingredient in AMLODIPINE AND OLMESARTAN MEDOXOMIL 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.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for AMLODIPINE AND OLMESARTAN MEDOXOMIL?
  • What are the global sales for AMLODIPINE AND OLMESARTAN MEDOXOMIL?
  • What is Average Wholesale Price for AMLODIPINE AND OLMESARTAN MEDOXOMIL?
Summary for AMLODIPINE AND OLMESARTAN MEDOXOMIL
US Patents:0
Applicants:13
NDAs:13
Finished Product Suppliers / Packagers: 15
Clinical Trials: 14
What excipients (inactive ingredients) are in AMLODIPINE AND OLMESARTAN MEDOXOMIL?AMLODIPINE AND OLMESARTAN MEDOXOMIL excipients list
DailyMed Link:AMLODIPINE AND OLMESARTAN MEDOXOMIL at DailyMed
Drug patent expirations by year for AMLODIPINE AND OLMESARTAN MEDOXOMIL
Recent Clinical Trials for AMLODIPINE AND OLMESARTAN MEDOXOMIL

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

SponsorPhase
Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo CompanyPhase 3
Daiichi Sankyo Korea Co., Ltd.Phase 3
Torrent Pharmaceuticals LimitedPhase 1

See all AMLODIPINE AND OLMESARTAN MEDOXOMIL clinical trials

US Patents and Regulatory Information for AMLODIPINE AND OLMESARTAN MEDOXOMIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 091154-001 Oct 26, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 206884-004 Oct 26, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 207771-001 Sep 22, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Torrent AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 202933-001 Nov 25, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

AMLODIPINE AND OLMESARTAN MEDOXOMIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine and Olmesartan Medoxomil

Introduction

Amlodipine and Olmesartan Medoxomil is a combination medication widely used to treat hypertension (high blood pressure). This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this medication.

Market Size and Forecast

The Amlodipine and Olmesartan Market 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].

Mechanism of Action

Amlodipine, a calcium channel blocker, relaxes blood vessels by inhibiting the influx of calcium ions into vascular smooth muscle and cardiac muscle. Olmesartan, an angiotensin II receptor blocker, prevents blood vessel constriction by blocking the action of angiotensin II. This combination is effective in managing blood pressure levels in patients who require multiple therapies for optimal control[1].

Key Applications

Hospitals

Hospitals dominate the application segment due to their comprehensive patient management capabilities and the presence of specialized medical personnel. Hospitals play a crucial role in the initial treatment and stabilization of patients with hypertension, leading to higher medication usage[1].

Drug Stores

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. This shift reflects a broader trend towards patient empowerment and convenience in healthcare[1].

Regional Market 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 strong regulatory support. 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. According to the Centers for Disease Control and Prevention (CDC), 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, 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. The World Health Organization (WHO) estimates that hypertension affects about 30% of the adult population in these countries, highlighting a vast potential customer base for these 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, forcing pharmaceutical companies to differentiate their products through improved formulations and combination therapies[1][3].

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 necessitate careful patient monitoring and education[1][2].

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. This regulatory environment can limit growth opportunities and require pharmaceutical companies to invest heavily in research and development[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 fluctuate market dynamics and impact the financial trajectory of the medication[1].

Pharmacoeconomic Impact

Studies have shown that the combination of Amlodipine and Olmesartan is cost-effective in treating hypertension. For instance, a study in China found that the fixed-dose combination of Olmesartan and Amlodipine led to fewer cardiovascular events and deaths, and was more cost-effective compared to other treatment options[5].

Recent Developments

  • 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, which are recognized as bioequivalent to Daiichi Sankyo’s Azor®. This approval is expected to cater to a significant market demand[1].
  • In August 2024, Hikma Pharmaceuticals successfully launched its generic version of Amlodipine and Olmesartan in the U.S. market, expanding its generic product line and leveraging its existing distribution channels and manufacturing capabilities[1].

Market Projections and Forecast

The global market for Amlodipine and Olmesartan is expected to continue its upward trajectory, driven by the increasing prevalence of cardiovascular diseases, advancements in pharmaceutical formulations, and the growing adoption of online retail channels. The market is projected to reach USD 824.65 million by 2031, with a CAGR of 4.10% from 2024 to 2031[1].

Key Takeaways

  • The Amlodipine and Olmesartan Market is growing steadily, driven by the rising prevalence of hypertension and cardiovascular diseases.
  • North America and the Asia Pacific region are key markets, with the latter experiencing rapid growth.
  • The competitive landscape is robust, with major pharmaceutical companies competing for market share.
  • Generic competition and regulatory hurdles are significant challenges.
  • The combination is cost-effective and leads to better health outcomes compared to other treatment options.

FAQs

Q1: What is the current market size of the Amlodipine and Olmesartan Market?

The Amlodipine and Olmesartan Market was valued at USD 597.95 million in 2023[1].

Q2: What is the projected growth rate of the Amlodipine and Olmesartan Market?

The market is projected to grow at a CAGR of 4.10% from 2024 to 2031[1].

Q3: Which regions are driving the growth of the Amlodipine and Olmesartan Market?

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

Q4: What are the main challenges facing the Amlodipine and Olmesartan Market?

Generic competition, adverse drug reactions, regulatory hurdles, and economic factors are the main challenges[1].

Q5: Is the combination of Amlodipine and Olmesartan cost-effective?

Yes, studies have shown that the fixed-dose combination of Olmesartan and Amlodipine is cost-effective and leads to better health outcomes compared to other treatment options[5].

Sources

  1. Verified Market Research: Amlodipine And Olmesartan Market Size, Share, Trends & Forecast.
  2. FDA: TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide).
  3. Drug Patent Watch: Generic AMLODIPINE BESYLATE INN equivalents, drug patent.
  4. Mayo Clinic: Olmesartan, amlodipine, and hydrochlorothiazide (oral route).
  5. PubMed: Economic evaluation of olmesartan/amlodipine fixed-dose combination.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.