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Last Updated: April 18, 2025

Indecainide hydrochloride - Generic Drug Details


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What are the generic sources for indecainide hydrochloride and what is the scope of freedom to operate?

Indecainide hydrochloride is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for indecainide hydrochloride
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 21
Patent Applications: 86
DailyMed Link:indecainide hydrochloride at DailyMed

US Patents and Regulatory Information for indecainide hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lilly DECABID indecainide hydrochloride TABLET, EXTENDED RELEASE;ORAL 019693-001 Dec 29, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lilly DECABID indecainide hydrochloride TABLET, EXTENDED RELEASE;ORAL 019693-002 Dec 29, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lilly DECABID indecainide hydrochloride TABLET, EXTENDED RELEASE;ORAL 019693-003 Dec 29, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Expired US Patents for indecainide hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Lilly DECABID indecainide hydrochloride TABLET, EXTENDED RELEASE;ORAL 019693-001 Dec 29, 1989 4,452,745 ⤷  Try for Free
Lilly DECABID indecainide hydrochloride TABLET, EXTENDED RELEASE;ORAL 019693-002 Dec 29, 1989 4,382,093 ⤷  Try for Free
Lilly DECABID indecainide hydrochloride TABLET, EXTENDED RELEASE;ORAL 019693-002 Dec 29, 1989 4,389,393 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Indecainide Hydrochloride

Introduction

Indecainide hydrochloride, a rarely used antidysrhythmic drug, belongs to the membrane stabilizing (Class 1) group of antiarrhythmic agents. Despite its specific use case, understanding the market dynamics and financial trajectory of such drugs can provide valuable insights into the broader antiarrhythmic drug market.

Market Overview of Antiarrhythmic Drugs

The global critical care antiarrhythmic drugs market has been experiencing significant growth, driven by factors such as the increasing prevalence of cardiovascular disorders and the rising adoption of these drugs in intensive care units (ICUs)[1].

Current Market Size and Growth Projections

As of 2019, the global critical care antiarrhythmic drugs market size was USD 796.8 million. It is projected to grow to USD 1,319.7 million by 2027, exhibiting a Compound Annual Growth Rate (CAGR) of 5.6% during the 2020-2027 period. This growth is largely attributed to the increasing number of cardiac disorders and the high demand for effective treatments in ICUs[1].

Segment Analysis

The antiarrhythmic drugs market is segmented by drug class, with beta blockers expected to be the leading segment. However, the potassium channel blockers segment is also anticipated to witness lucrative growth due to its effectiveness in treating atrial fibrillation and related arrhythmias[1].

Regional Market Dynamics

  • North America: This region held a significant market share in 2019, with a market size of USD 359.2 million. The presence of numerous clinical trials and drug launches in the U.S. is a key driver for this region[1].
  • Europe: Europe is projected to be the second-largest region, driven by a rising geriatric population and favorable reimbursement policies[1].
  • Asia Pacific: This region is expected to grow at a high rate due to government initiatives raising awareness about the ill effects of prolonged atrial fibrillation and increasing healthcare spending[1].

Specifics of Indecainide Hydrochloride

Mechanism of Action

Indecainide acts on sodium channels on the neuronal cell membrane, limiting the spread of seizure activity and reducing seizure propagation. Its antiarrhythmic actions are mediated through effects on sodium channels in Purkinje fibers[4].

Clinical Use

Indecainide is indicated for the treatment of life-threatening dysrhythmias and sustained ventricular tachycardia. However, it is rarely used due to its specific side effect profile and the availability of other more commonly prescribed antiarrhythmic drugs[4].

Regulatory Status

Indecainide is not approved in the U.S. or other major markets, which significantly limits its market presence and financial impact compared to other antiarrhythmic drugs[4].

Financial Trajectory

Given its rare use and lack of approval in major markets, the financial trajectory of indecainide hydrochloride is not as robust as other antiarrhythmic drugs.

Revenue Contribution

The revenue generated by indecainide hydrochloride is minimal compared to the overall antiarrhythmic drugs market. This is due to its limited clinical use and the absence of significant market approvals.

Research and Development

While the broader antiarrhythmic drugs market benefits from increasing investments in research and development, indecainide hydrochloride does not see substantial R&D activities due to its niche status and limited market potential[1].

Competitive Landscape

The antiarrhythmic drugs market is dominated by major pharmaceutical companies such as Sanofi, Pfizer, and Mylan N.V. These companies have a strong presence in the market with a variety of approved drugs, unlike indecainide hydrochloride which is not a major player[1].

Challenges and Opportunities

Challenges

  • Limited Approval: The lack of approval in major markets significantly hampers the market potential of indecainide hydrochloride.
  • Rare Use: Its rare clinical use limits the revenue generation and market impact.
  • Side Effects: The drug's side effect profile, including nausea, vomiting, and cardiac complications, can deter its adoption[4].

Opportunities

  • Niche Markets: There may be opportunities in niche markets or specific patient populations where indecainide hydrochloride could be more effective than other antiarrhythmic drugs.
  • Research: Further research could potentially uncover new uses or improve the safety profile of indecainide hydrochloride, although this is speculative given its current status.

Key Takeaways

  • The global critical care antiarrhythmic drugs market is growing, driven by increasing cardiovascular disorders and ICU adoption.
  • Indecainide hydrochloride, despite its specific mechanism of action, has a limited market presence due to its rare use and lack of major market approvals.
  • The financial trajectory of indecainide hydrochloride is not significant compared to other antiarrhythmic drugs.
  • Opportunities for indecainide hydrochloride may exist in niche markets or through further research, but these are limited.

FAQs

What is the current market size of the global critical care antiarrhythmic drugs market?

The global critical care antiarrhythmic drugs market size was USD 796.8 million in 2019 and is projected to reach USD 1,319.7 million by 2027[1].

What is the mechanism of action of indecainide hydrochloride?

Indecainide hydrochloride acts on sodium channels on the neuronal cell membrane, limiting the spread of seizure activity and reducing seizure propagation. Its antiarrhythmic actions are mediated through effects on sodium channels in Purkinje fibers[4].

Why is indecainide hydrochloride rarely used?

Indecainide hydrochloride is rarely used due to its specific side effect profile and the availability of other more commonly prescribed antiarrhythmic drugs. It also lacks approval in major markets[4].

What are the key drivers of the antiarrhythmic drugs market?

The key drivers include the increasing prevalence of cardiac disorders, growing adoption in ICUs, rising geriatric populations, and a high willingness to spend on anti-arrhythmia drug research[1].

Which regions are expected to see significant growth in the antiarrhythmic drugs market?

North America, Europe, and the Asia Pacific are expected to see significant growth, with the Asia Pacific region growing at a particularly high rate[1].

What are the challenges faced by indecainide hydrochloride in the market?

The challenges include limited approval in major markets, rare clinical use, and a significant side effect profile[4].

Sources

  1. Fortune Business Insights: Critical Care Antiarrhythmic Drugs Market Size, Share & Report, 2027.
  2. PubChem: Indecainide | C20H24N2O | CID 52195.
  3. PubMed: The economics of follow-on drug research and development.
  4. DrugBank: Indecainide: Uses, Interactions, Mechanism of Action.

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