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Last Updated: December 26, 2024

ORAP Drug Patent Profile


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US Patents and Regulatory Information for ORAP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva ORAP pimozide TABLET;ORAL 017473-003 Aug 27, 1997 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-001 Jun 1, 2006 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva ORAP pimozide TABLET;ORAL 017473-001 Jul 31, 1984 DISCN Yes 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

ORAP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oral Transmucosal Drugs: A Deep Dive

Introduction to Oral Transmucosal Drugs

Oral transmucosal drugs are designed to be administered through the mucous membranes in the mouth, bypassing the digestive system and providing rapid absorption into the bloodstream. This method of drug delivery has gained significant attention due to its efficiency and the growing demand for innovative drug delivery systems.

Market Growth and Projections

The global oral transmucosal drugs market is poised for substantial growth, with a projected compound annual growth rate (CAGR) of 7.8% from 2023 to 2030. This growth is driven by the increasing demand for efficient and rapid drug delivery systems, particularly for medications that require swift absorption into the bloodstream[1].

Regional Market Dominance

North America is currently the dominant region in the oral transmucosal drugs market, largely due to the high prevalence of conditions such as Parkinson's, Alzheimer's, and dysphagia. The region also benefits from a strong geriatric population and a willingness to adopt innovative oral transmucosal drugs. Notable developments, such as the FDA's acceptance of new drug applications, further support the market's expansion in this region[1].

Key Drivers of Market Growth

Technological Advancements

Advancements in pharmaceutical formulations and technology have been instrumental in the development of innovative oral transmucosal drug products. Companies like Oramed Pharmaceuticals are pioneering platform technologies for oral drug delivery, including the Protein Oral Delivery (PODâ„¢) technology, which protects drug integrity and increases absorption[2].

Increasing Prevalence of Target Conditions

The rising prevalence of conditions that benefit from oral transmucosal drug delivery, such as pain management and opioid use disorders, is a significant driver of market growth. For instance, the persistent global opioid use disorder and addiction crisis have highlighted the need for effective oral transmucosal drugs[1].

Patient-Centric Approach

The shift towards patient-centric drug delivery systems is another key factor. Oral transmucosal drugs offer a more convenient and less invasive method of administration, which enhances patient compliance and usability. This is particularly important for older patient populations who may struggle with traditional drug delivery methods[4].

Financial Trajectory

Market Size and Revenue

The oral transmucosal drugs market is expected to see significant revenue growth. While specific financial figures for the oral transmucosal segment are not isolated, the broader oral solid dosage pharmaceutical market provides a context. This market is expected to grow from US$ 524.6 billion in 2021 to US$ 1.03 trillion by 2032, with a CAGR of 6.4%[4].

Investment and Funding

Companies in the oral transmucosal drugs market are securing substantial investments to drive innovation and expansion. For example, Oramed Pharmaceuticals has executed definitive agreements for a new financing of $50 million and has also secured warrants and conversion options, indicating a strong financial trajectory for companies in this sector[2].

Competitive Landscape

Major Players

The market is characterized by the presence of several key players, including Oramed Pharmaceuticals, which is a pioneer in oral delivery solutions for drugs currently delivered via injection. Other companies, such as Aquestive Therapeutics, are also making significant strides with FDA approvals and new product launches[1][2].

Strategic Partnerships and Restructuring

Strategic partnerships and financial restructuring are common in this market. Oramed Pharmaceuticals' restructuring of its debt with Scilex Holding Company and the acquisition of royalty rights on certain products demonstrate the dynamic financial strategies employed by market players[2].

Regulatory Environment

FDA Approvals and Guidelines

The regulatory environment plays a crucial role in the growth of the oral transmucosal drugs market. FDA approvals, such as the acceptance of new drug applications, are critical for market expansion. The FDA's proactive stance on approving innovative oral drug delivery systems supports the market's growth[1].

Patient Impact and Clinical Benefits

Rapid Absorption and Efficacy

Oral transmucosal drugs offer rapid absorption into the bloodstream, which is particularly beneficial for conditions requiring immediate drug action. This method of delivery can significantly improve the efficacy of medications, especially in pain management and emergency situations.

Patient Compliance

The convenience and ease of use of oral transmucosal drugs enhance patient compliance. This is especially important for chronic conditions where adherence to medication regimens is crucial for effective management.

Challenges and Concerns

Cost Implications

Despite the clinical benefits, the cost of oral transmucosal drugs can be a significant challenge. The high prices of new cancer drugs, for example, have raised concerns about the quantity and quality of evidence supporting their approval and the subsequent financial burden on patients and healthcare systems[5].

Clinical Evidence and Approval

The lack of documented clinical benefits for some oral targeted cancer drugs has raised questions about the approval process and the cost-effectiveness of these medications. Ensuring robust clinical evidence to support the approval of new drugs is essential for maintaining trust and ensuring patient safety[5].

Key Takeaways

  • Market Growth: The oral transmucosal drugs market is expected to grow at a CAGR of 7.8% from 2023 to 2030.
  • Regional Dominance: North America leads the market due to high prevalence of target conditions and a strong geriatric population.
  • Technological Advancements: Innovations in pharmaceutical formulations and technology are driving market growth.
  • Patient-Centric Approach: Enhanced patient compliance and usability are key drivers.
  • Financial Trajectory: Significant investments and strategic partnerships are supporting market expansion.
  • Regulatory Environment: FDA approvals are crucial for market growth.
  • Patient Impact: Rapid absorption and improved efficacy are significant clinical benefits.

FAQs

What is the expected CAGR for the oral transmucosal drugs market from 2023 to 2030?

The oral transmucosal drugs market is expected to grow at a CAGR of 7.8% from 2023 to 2030[1].

Which region dominates the oral transmucosal drugs market?

North America currently dominates the oral transmucosal drugs market due to the high prevalence of target conditions and a strong geriatric population[1].

What technological advancements are driving the market growth?

Advancements in pharmaceutical formulations and technology, such as Oramed Pharmaceuticals' Protein Oral Delivery (PODâ„¢) technology, are driving market growth[2].

How do oral transmucosal drugs improve patient compliance?

Oral transmucosal drugs offer a more convenient and less invasive method of administration, enhancing patient compliance and usability, especially for older patient populations[4].

What are the cost implications of oral transmucosal drugs?

The cost of oral transmucosal drugs can be significant, raising concerns about the financial burden on patients and healthcare systems, particularly for conditions like cancer[5].

How important are FDA approvals for the oral transmucosal drugs market?

FDA approvals are critical for the growth of the oral transmucosal drugs market, as they validate the safety and efficacy of new drug delivery systems[1].

Sources

  1. Grand View Research: Oral Transmucosal Drugs Market Size & Share Report, 2030.
  2. PR Newswire: Oramed Pharmaceuticals Announces Restructuring of Scilex Holding Company Debt.
  3. Mordor Intelligence: North America Oral Anti-Diabetic Drug Market Size & Share Analysis.
  4. Fact.MR: Oral Solid Dosage Pharmaceutical Market Size & Trends 2032.
  5. JAMA Network: Real-world Use of and Spending on New Oral Targeted Cancer Drugs Among US Residents.

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