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Last Updated: December 22, 2024

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE Drug Patent Profile


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When do Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide patents expire, and when can generic versions of Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide launch?

Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide is a drug marketed by Endo Operations, Teva Pharms Usa, and Torrent. and is included in three NDAs.

The generic ingredient in OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.

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Summary for OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
US Patents:0
Applicants:3
NDAs:3
Finished Product Suppliers / Packagers: 5
Clinical Trials: 8
What excipients (inactive ingredients) are in OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE?OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE at DailyMed
Drug patent expirations by year for OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Recent Clinical Trials for OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

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 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE clinical trials

US Patents and Regulatory Information for OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 206137-001 Oct 26, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 202491-002 Nov 3, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 206137-004 Oct 26, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Torrent OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 203580-002 Oct 26, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 202491-003 Nov 3, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Torrent OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 203580-004 Oct 26, 2016 AB RX 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

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide

Introduction

The combination of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide is a potent antihypertensive medication used to treat high blood pressure. This article delves into the market dynamics and financial trajectory of this drug combination, highlighting key factors influencing its growth and challenges.

Market Size and Forecast

The market for Amlodipine and Olmesartan, key components of this combination, 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% from 2024 to 2031[1].

Mechanism of Action

This combination therapy works through the synergistic effects of its components:

  • Olmesartan Medoxomil: An angiotensin II receptor blocker (ARB) that relaxes blood vessels by blocking the action of angiotensin II, a substance that causes blood vessels to tighten[5].
  • Amlodipine: A calcium channel blocker (CCB) that affects the movement of calcium into the cells of the heart and blood vessels, leading to vasodilation and reduced blood pressure[5].
  • Hydrochlorothiazide: A diuretic that reduces the volume of water in the blood, further lowering blood pressure[2].

Market Drivers

Growing Prevalence of Hypertension

The increasing global incidence of hypertension, particularly in regions like North America and the Asia Pacific, drives the demand for effective antihypertensive medications. In the U.S., approximately 47% of adults have hypertension, while in countries like India and China, about 30% of the adult population is affected[1].

Advancements in Drug Formulations

The development of combination therapies like TRIBENZOR™, which combines Olmesartan, Amlodipine, and Hydrochlorothiazide, offers a simple and effective treatment option for patients who require multiple therapies. Such innovations enhance patient outcomes and drive market growth[2].

Regulatory Support

Strong regulatory support and favorable reimbursement policies in regions like North America encourage the adoption of innovative healthcare solutions, including combination antihypertensive medications[1].

Market Challenges

Generic Competition

The entry of generic versions of these medications poses a significant challenge. Companies like Aurobindo Pharma Limited and Hikma Pharmaceuticals have received FDA approvals for their generic versions, which can lead to price erosion and reduced profit margins for branded products[1].

Adverse Drug Reactions

Potential side effects such as dizziness, swelling, or gastrointestinal issues may deter patients from continuing their prescribed treatment, impacting market demand. Caution is advised in patients with conditions like hyponatremia, congestive heart failure, or liver disease[5].

Regulatory Hurdles

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

Economic Factors

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

Regional Market Dynamics

North America

North America is the dominant region in the market, driven by a robust healthcare infrastructure, high prevalence of hypertension, and strong regulatory support. The U.S. and Canada contribute significantly 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, 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

The global market is segmented into hospitals and drug stores. Hospitals dominate due to their comprehensive patient management capabilities, while the drug stores segment is the fastest-growing, driven by increasing patient self-management of chronic conditions and a preference for over-the-counter access to antihypertensive medications[1].

Key Products and Launches

  • TRIBENZOR™: Approved by the FDA in 2010, this three-in-one pill combines Olmesartan, Amlodipine, and Hydrochlorothiazide, offering a simple and effective therapy for patients not adequately controlled on dual combination therapies[2].
  • Sevikar™: A fixed-dose combination of Amlodipine and Olmesartan, for which Daiichi Sankyo filed a marketing authorization application in Europe, expected to be marketed as Sevikar™[3].

Financial Impact of Generic Entries

The launch of generic versions by companies like Aurobindo Pharma Limited and Hikma Pharmaceuticals in 2024 is expected to impact the financial trajectory of branded products. For instance, Aurobindo Pharma’s generic version of Amlodipine and Olmesartan Medoxomil Tablets received final FDA approval, which will cater to a significant market segment[1].

Public Health Initiatives

Public health initiatives aimed at reducing cardiovascular risks further solidify the demand for these medications. For example, the American Heart Association’s emphasis on managing hypertension has resulted in a surge in prescriptions for Amlodipine and Olmesartan[1].

Conclusion

The market for Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide is driven by the growing prevalence of hypertension, advancements in drug formulations, and strong regulatory support. However, it faces challenges from generic competition, adverse drug reactions, regulatory hurdles, and economic factors.

Key Takeaways

  • The market for Amlodipine and Olmesartan is projected to grow at a CAGR of 4.10% from 2024 to 2031.
  • Combination therapies like TRIBENZOR™ offer effective treatment options for patients with hypertension.
  • Generic competition and adverse drug reactions are significant challenges.
  • North America and the Asia Pacific are key regions driving market growth.
  • Public health initiatives and regulatory support are crucial for market expansion.

FAQs

Q: What is the primary use of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide?

A: This combination is primarily used to treat high blood pressure (hypertension) in patients who require multiple therapies for effective control.

Q: What are the key components of TRIBENZOR™?

A: TRIBENZOR™ combines Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide, each working differently to lower blood pressure.

Q: Which regions are driving the growth of the Amlodipine and Olmesartan market?

A: North America and the Asia Pacific are the dominant and fastest-growing regions, respectively, driven by robust healthcare infrastructure and rising prevalence of hypertension.

Q: What are the challenges faced by the market for this drug combination?

A: The market faces challenges from generic competition, adverse drug reactions, regulatory hurdles, and economic factors.

Q: How do public health initiatives impact the market for these medications?

A: Public health initiatives aimed at reducing cardiovascular risks increase the demand for effective antihypertensive medications like Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide.

Sources

  1. Verified Market Research - Amlodipine And Olmesartan Market Size, Share, Trends & Forecast
  2. Daiichi Sankyo - FDA APPROVES TRIBENZOR™, A NEW THREE-IN-ONE ...
  3. Euroland - A Future of Innovation
  4. Geneesmiddeleninformatiebank - Public Assessment Report
  5. Mayo Clinic - Olmesartan, amlodipine, and hydrochlorothiazide (oral route)

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