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Last Updated: December 23, 2024

ISMOTIC Drug Patent Profile


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Which patents cover Ismotic, and when can generic versions of Ismotic launch?

Ismotic is a drug marketed by Alcon and is included in one NDA.

The generic ingredient in ISMOTIC is isosorbide. There are thirty-seven drug master file entries for this compound. Additional details are available on the isosorbide profile page.

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Summary for ISMOTIC
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 86
Patent Applications: 3,430
DailyMed Link:ISMOTIC at DailyMed
Drug patent expirations by year for ISMOTIC

US Patents and Regulatory Information for ISMOTIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon ISMOTIC isosorbide SOLUTION;ORAL 017063-001 Approved Prior to Jan 1, 1982 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

ISMOTIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Osmotic Pumps

Market Overview

The osmotic pumps market is poised for significant growth, driven by the increasing demand for targeted and controlled drug delivery systems. Here are the key dynamics and financial projections for this market.

Market Size and Growth Projections

  • The global osmotic pumps market was valued at USD 7.8 billion in 2023 and is expected to reach USD 8.5 billion by 2024. By 2034, the market is projected to expand to USD 18.2 billion, growing at a Compound Annual Growth Rate (CAGR) of 7.9% between 2024 and 2034[1][4].

Segmentation and Key Markets

  • The market is segmented into oral osmotic pumps and implantable osmotic pumps. The oral osmotic pump segment dominated the market, holding 76.2% of the share in 2023[1].
  • Geographically, North America is the largest market shareholder, driven by advanced healthcare infrastructure, high healthcare expenditure, and robust investment in healthcare R&D. The Asia Pacific region is expected to be the fastest-growing market during the forecast period[4].

Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

  • The rising prevalence of chronic diseases such as diabetes, cardiovascular diseases, and chronic pain is a significant driver. For instance, the International Diabetes Federation estimates that the number of adults with diabetes will increase from 537 million in 2021 to 643 million by 2030[4].

Advancements in Technology and Design

  • Advancements in pump design and drug formulation have made osmotic pumps more efficient and safe. Technologies combining osmosis, swelling, and effervescence allow for more customized and complex drug release profiles[1][4].

Personalized Medicine and Targeted Delivery

  • The trend towards personalized medicine and away from conventional dosage forms is another key driver. Osmotic pumps offer better patient compliance, minimized side effects, and improved therapeutic outcomes, making them a preferred choice for long-term therapy[4].

Challenges and Barriers

Safety Concerns and Regulatory Hurdles

  • Historical safety concerns, such as gastrointestinal tract infections and obstructions, have been addressed through improved design and materials. However, stringent regulatory procedures remain a barrier to market entry[1][5].

High Costs

  • The high cost of developing and manufacturing osmotic pumps is another challenge. The total capital investment for setting up a production facility can be substantial, with estimates ranging from $61 million to $500 million for FDA approvals and equipment validation[2].

Financial Trajectory

Revenue and Profitability

  • Despite the high initial investment, osmotic pump ventures can be highly profitable. For example, a project involving the production of osmotic tablets for treating benign prostatic hyperplasia (BPH) is expected to reach a financial break-even point in under two years, with annual revenues of approximately $300 million[2].

Cost Structure

  • The cost structure includes significant investments in equipment, raw materials, and quality control. The annual manufacturing cost can be around $156 million, but the revenue generated far outweighs these expenses[2].

Industry Collaborations and Research

  • Manufacturers are collaborating with academic institutions and research facilities to expand the applications of osmotic pumps. Integrations with IT companies are also underway to enhance clinical and research infrastructure[1].

Recent Industry Developments

  • Recent advancements include the use of advanced imaging technologies to ensure uniformity in the semipermeable membrane and to monitor processing steps. This has improved the quality and performance of osmotic pumps[1].

End-User Segmentation

  • The market is segmented into hospitals, ambulatory surgical centers, specialty clinics, and homecare settings. The demand from these segments is driven by the need for controlled and targeted drug delivery systems[1].

Regional Insights

  • North America leads in terms of market share due to its advanced healthcare infrastructure and high healthcare expenditure. The Asia Pacific region is expected to grow rapidly, driven by increasing healthcare investments and a growing awareness of the benefits of osmotic pumps[4].

Key Takeaways

  • The osmotic pumps market is growing rapidly, driven by the need for controlled and targeted drug delivery systems.
  • Chronic diseases such as diabetes, cardiovascular diseases, and chronic pain are key drivers of this market.
  • Advancements in technology and design, along with personalized medicine trends, are boosting market growth.
  • Despite high costs and regulatory hurdles, the market offers significant profitability and growth opportunities.

FAQs

What is the projected market size of osmotic pumps by 2034?

The osmotic pumps market is expected to reach USD 18.2 billion by 2034[1].

What is the CAGR of the osmotic pumps market between 2024 and 2034?

The market is projected to grow at a CAGR of 7.9% between 2024 and 2034[1][4].

Which segment dominates the osmotic pumps market?

The oral osmotic pump segment dominates the market, holding 76.2% of the share in 2023[1].

What are the main drivers of the osmotic pumps market?

The main drivers include the increasing prevalence of chronic diseases, advancements in technology and design, and the trend towards personalized medicine[1][4].

What are the major challenges facing the osmotic pumps market?

The major challenges include safety concerns, high costs, and stringent regulatory procedures[1][5].

Cited Sources

  1. Future Market Insights - Osmotic Pumps Market Size, Industry Share & Trends - 2034
  2. University of Oklahoma - Engineering Drug Delivery - The University of Oklahoma
  3. National Bureau of Economic Research - The Economics of Drug Development: Pricing and Innovation in a Changing Market
  4. Straits Research - Osmotic Pumps Market Size, Top Share, Demand, Forecast to 2032
  5. IJRPC - OSMOTIC PUMP DRUG DELIVERY- A NOVEL APPROACH

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