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Last Updated: December 26, 2024

ETHMOZINE Drug Patent Profile


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When do Ethmozine patents expire, and what generic alternatives are available?

Ethmozine is a drug marketed by Shire and is included in one NDA.

The generic ingredient in ETHMOZINE is moricizine hydrochloride. Additional details are available on the moricizine hydrochloride profile page.

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Summary for ETHMOZINE
Drug patent expirations by year for ETHMOZINE
Recent Clinical Trials for ETHMOZINE

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

SponsorPhase
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
National Heart, Lung, and Blood Institute (NHLBI)Phase 2

See all ETHMOZINE clinical trials

US Patents and Regulatory Information for ETHMOZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-001 Jun 19, 1990 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-002 Jun 19, 1990 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-003 Jun 19, 1990 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

Expired US Patents for ETHMOZINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-001 Jun 19, 1990 3,740,395 ⤷  Subscribe
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-003 Jun 19, 1990 3,864,487 ⤷  Subscribe
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-003 Jun 19, 1990 3,740,395 ⤷  Subscribe
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-002 Jun 19, 1990 3,864,487 ⤷  Subscribe
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-001 Jun 19, 1990 3,864,487 ⤷  Subscribe
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-002 Jun 19, 1990 3,740,395 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ETHMOZINE

See the table below for patents covering ETHMOZINE around the world.

Country Patent Number Title Estimated Expiration
Germany 2014201 HYDROCHLORID DES 10-(BETA-MORPHOLINOPROPIONYL)-PHENOTHIAZIN-2-CARBAMIN-SAEUREAETHYLESTERS, VERFAHREN ZU DESSEN HERSTELLUNG UND PHARMAZEUTISCHES MITTEL ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

ETHMOZINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ethmozine

Introduction

Ethmozine, also known as moricizine, is a Class I antiarrhythmic agent used to treat ventricular arrhythmias. Understanding its market dynamics and financial trajectory involves examining its clinical efficacy, market reception, and the broader financial context of the pharmaceutical industry.

Clinical Efficacy of Ethmozine

Ethmozine has been shown to be effective in reducing ventricular premature complexes (VPCs) and ventricular tachycardia (VT) in clinical trials. In one study, 65% of patients experienced a more than 75% reduction in VPC frequency, and 84% of patients had a more than 90% reduction in VT events of three beats or more[1][3][4].

Market Reception

The drug's market reception is influenced by its efficacy and safety profile. Ethmozine has been found to be clinically useful for suppressing VPCs in a selected population, although it has side effects and may not be effective for all patients. The drug prolongs PR and QRS intervals but does not significantly affect the JT interval, indicating its specific mechanism of action[1][4].

Financial Context of Antiarrhythmic Drugs

The financial trajectory of ethmozine is part of the larger landscape of antiarrhythmic drugs. The market for these drugs is competitive, with various other agents like disopyramide, propranolol, and quinidine. Ethmozine's financial performance would be compared to these alternatives in terms of efficacy, safety, and cost-effectiveness[4].

Funding and Capital in the Pharmaceutical Industry

Biotechnology and pharmaceutical companies, including those developing antiarrhythmic drugs, often face significant financial challenges. The industry is characterized by high risk, long lead times, and substantial capital requirements. Many biotech companies rely heavily on accessing public markets for capital to fund their research and development activities[2].

Initial Public Offerings (IPOs) and Venture Capital

The success of biotech companies, including those developing drugs like ethmozine, can be volatile. IPOs and venture capital play crucial roles in funding these companies. However, the market can be unpredictable, with companies experiencing significant fluctuations in stock prices based on clinical trial outcomes and regulatory approvals[2].

Ethmozine's Place in the Market

Ethmozine, being a specific treatment for ventricular arrhythmias, would need to compete with other antiarrhythmic agents. Its market share would depend on its clinical performance, side effect profile, and pricing strategy. The drug's ability to prevent the induction of sustained ventricular tachycardia in a significant portion of patients could be a selling point, but it must also navigate the complexities of healthcare reimbursement and regulatory approvals[4].

Regulatory and Clinical Trials Costs

The development and approval of ethmozine involve substantial costs associated with clinical trials and regulatory processes. These costs can be a significant burden for pharmaceutical companies, affecting their financial trajectory. Ethmozine's inclusion in studies like those conducted by the National Heart Lung and Blood Institute can influence its market acceptance and financial viability[4].

Patient and Physician Adoption

The adoption of ethmozine by patients and physicians is crucial for its financial success. Factors such as ease of dosing, side effect profile, and overall efficacy play significant roles. For instance, the study showing that ethmozine can be used effectively with a twice-daily dosing regimen could enhance its appeal to both patients and healthcare providers[3].

Pharmacokinetics and Pharmacodynamics

Ethmozine's pharmacokinetics, including its extensive first-pass metabolism and large volume of distribution, can affect its pricing and market positioning. The drug's unique pharmacodynamic profile, such as its ability to prolong PR and QRS intervals without affecting the JT interval, may also influence its market dynamics[4].

Competitive Landscape

The competitive landscape for antiarrhythmic drugs is intense, with several established and newer agents vying for market share. Ethmozine's financial trajectory would be influenced by how it compares to other drugs in terms of efficacy, safety, and cost. Its ability to prevent sustained ventricular tachycardia and reduce VPC frequency would need to be highlighted to differentiate it from competitors[4].

Market Fluctuations and Risks

The biotech and pharmaceutical industries are known for their volatility. Companies developing drugs like ethmozine face risks such as clinical trial failures, regulatory setbacks, and market fluctuations. For example, the story of Synergen, a biotech company that saw its stock plummet after a drug failure, highlights the risks involved[2].

Financial Performance Metrics

The financial performance of ethmozine would be evaluated based on metrics such as revenue growth, market share, and return on investment. The drug's ability to generate consistent revenue and maintain market share over time would be critical for its financial success.

Conclusion

Ethmozine's market dynamics and financial trajectory are influenced by its clinical efficacy, competitive landscape, and the broader financial context of the pharmaceutical industry. While the drug has shown promise in treating ventricular arrhythmias, its financial success depends on various factors including patient and physician adoption, regulatory approvals, and market positioning.

Key Takeaways

  • Clinical Efficacy: Ethmozine is effective in reducing VPCs and VT in clinical trials.
  • Market Reception: The drug's market reception is influenced by its efficacy and safety profile.
  • Financial Context: The pharmaceutical industry is characterized by high risk and significant capital requirements.
  • Competitive Landscape: Ethmozine competes with other antiarrhythmic agents in a competitive market.
  • Regulatory and Clinical Trials Costs: Substantial costs are associated with clinical trials and regulatory processes.
  • Patient and Physician Adoption: Ease of dosing and side effect profile are crucial for adoption.

FAQs

What is Ethmozine used for?

Ethmozine is used to treat ventricular arrhythmias, including ventricular premature complexes (VPCs) and ventricular tachycardia (VT).

How effective is Ethmozine in clinical trials?

Ethmozine has been shown to reduce VPC frequency by more than 75% in 65% of patients and VT events by more than 90% in 84% of patients in clinical trials[1][3][4].

What are the common side effects of Ethmozine?

Common side effects include transient side effects such as hyperanxiety and drug-related left anterior hemiblock. Some patients may also experience prolongation of PR and QRS intervals[1][3][4].

How does Ethmozine compare to other antiarrhythmic drugs?

Ethmozine's antiarrhythmic activity is generally similar to that of disopyramide, propranolol, and quinidine at the doses studied. It has a unique pharmacodynamic profile that differentiates it from other agents[4].

What are the financial risks associated with developing drugs like Ethmozine?

The development of drugs like Ethmozine involves high financial risks due to the volatility of the biotech and pharmaceutical markets, clinical trial failures, and regulatory setbacks[2].

Sources

  1. PubMed: Ethmozine for ventricular premature complexes.
  2. Boston University Journal of Science & Technology Law: Financing the Biotech Industry.
  3. PubMed: Safety and efficacy of a twice-daily dosing regimen for moricizine.
  4. Drugs.com: Ethmozine: Package Insert / Prescribing Information.

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