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Last Updated: December 22, 2024

ORA-TESTRYL Drug Patent Profile


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Which patents cover Ora-testryl, and when can generic versions of Ora-testryl launch?

Ora-testryl is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in ORA-TESTRYL is fluoxymesterone. There are three drug master file entries for this compound. Additional details are available on the fluoxymesterone profile page.

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Summary for ORA-TESTRYL
Drug patent expirations by year for ORA-TESTRYL

US Patents and Regulatory Information for ORA-TESTRYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb ORA-TESTRYL fluoxymesterone TABLET;ORAL 011359-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb ORA-TESTRYL fluoxymesterone TABLET;ORAL 011359-002 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

ORA-TESTRYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oral Transmucosal Drugs: A Focus on ORA-TESTRYL and Similar Formulations

Introduction

Oral transmucosal drugs, including formulations like ORA-TESTRYL, are experiencing significant growth due to their efficient and rapid drug delivery mechanisms. This article delves into the market dynamics, financial trajectory, and key factors influencing the oral transmucosal drugs market, with a particular focus on drugs similar to ORA-TESTRYL.

Market Growth and CAGR

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

Drivers of Market Growth

Several factors are driving the growth of the oral transmucosal drugs market:

Escalating Demand for Efficient Drug Delivery

Oral transmucosal drugs offer a more effective and rapid route of administration compared to traditional oral medications. This is particularly beneficial for pain management and certain medical conditions where quick absorption is crucial[1].

Advancements in Pharmaceutical Formulations

Technological advancements in pharmaceutical formulations and delivery systems have led to the creation of innovative oral transmucosal drug products. These advancements have broadened the applications of these drugs across various therapeutic areas[1].

Rising Incidence of Chronic Diseases

The increasing global prevalence of autoimmune diseases, Parkinson's disease, and cancer is a significant driver of the market. For instance, the worldwide prevalence of diabetes is projected to be substantial, contributing to the heightened demand for transmucosal medications[1].

Regulatory Approvals and New Product Launches

Regulatory approvals for new oral transmucosal drugs are expected to drive market growth. For example, the approval of asenapine sublingual tablets by the U.S. FDA in May 2021 is anticipated to augment the market's expansion[1].

Regional Market Dynamics

North America

North America dominated the oral transmucosal drugs market in 2022, driven by the high prevalence of target populations afflicted by Parkinson's, Alzheimer's, and dysphagia. The region benefits from a strong willingness to adopt innovative oral transmucosal drugs and a significant geriatric population[1].

Asia Pacific

The Asia Pacific region is expected to witness the highest growth rate due to the increasing prevalence of viral infections, growing healthcare expenditure, and rising investments in drug development. Countries like China, India, and Japan are at the forefront of this growth[4].

Key Players and Market Strategies

Key players in the oral transmucosal drugs market, such as ZIM Laboratories Limited, Sunovion Pharmaceuticals, Inc., and C.L.Pharm Co., Ltd., are consistently engaging in novel product development, mergers and acquisitions, and strategic alliances. These strategies are aimed at exploring fresh market opportunities and strengthening their market positions[1].

Financial Trajectory

The financial trajectory of the oral transmucosal drugs market is promising, with significant investments in research and development. The market's growth is expected to be fueled by the increasing demand for effective and rapid drug delivery systems. Here are some key financial insights:

Market Size and Growth

The global oral transmucosal drugs market is expected to grow substantially, driven by the factors mentioned above. The market size and growth projections indicate a robust financial future for this segment[1].

Revenue Streams

Revenue streams for oral transmucosal drugs are diverse, including sales from various therapeutic areas such as pain management, autoimmune diseases, and cancer treatment. The market also benefits from the growing demand for opioids and other pain relief medications[1].

Technological Advancements

Technological advancements in drug discovery, formulation technologies, and delivery systems are crucial for the growth of the oral transmucosal drugs market. These advancements have resulted in oral transmucosal drugs that offer improved efficacy, safety, and patient adherence[4].

Sustainability and Regulatory Trends

Sustainability trends are influencing the pharmaceutical industry, including the oral transmucosal drugs market. Pharmaceutical companies are focusing on developing environmentally friendly production processes and sustainable packaging solutions, driven by regulatory pressures and growing awareness of environmental sustainability[4].

ORA-TESTRYL and Similar Formulations

ORA-TESTRYL, known by its generic name fluoxymesterone, is an androgen and anabolic steroid medication. Here are some key points about ORA-TESTRYL and similar formulations:

Clinical Use

ORA-TESTRYL is administered orally to treat conditions such as cancer. It is known for its high oral bioavailability, with approximately 80% of the drug being absorbed when taken by mouth[2].

Side Effects and Precautions

The drug has several side effects, including changes in liver function, nausea, headache, and electrolyte changes. It also carries warnings for infertility, pregnancy, and breastfeeding due to its potential harmful effects on an unborn child and breastfeeding babies[5].

Market Position

While ORA-TESTRYL itself is not an oral transmucosal drug, its oral formulation highlights the importance of efficient drug delivery systems. The market for oral transmucosal drugs is more focused on medications that bypass gastrointestinal breakdown and deliver rapid therapeutic effects, which is a trend that ORA-TESTRYL's oral formulation aligns with in terms of efficiency.

Key Takeaways

  • The global oral transmucosal drugs market is expected to grow at a CAGR of 7.8% from 2023 to 2030.
  • The market is driven by the demand for efficient and rapid drug delivery systems, advancements in pharmaceutical formulations, and the rising incidence of chronic diseases.
  • North America dominates the market, while the Asia Pacific region is expected to witness the highest growth rate.
  • Key players are engaging in novel product development and strategic alliances to strengthen their market positions.
  • Technological advancements and sustainability trends are significant factors influencing the market.

FAQs

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

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

What are the primary drivers of the oral transmucosal drugs market?

The primary drivers include the escalating demand for efficient and rapid drug delivery systems, advancements in pharmaceutical formulations, and the rising incidence of chronic diseases such as autoimmune diseases, Parkinson's disease, and cancer[1].

Which region dominates the oral transmucosal drugs market?

North America dominates the oral transmucosal drugs market, driven by the high prevalence of target populations and a strong willingness to adopt innovative oral transmucosal drugs[1].

What are the key side effects of ORA-TESTRYL?

ORA-TESTRYL can cause side effects such as changes in liver function, nausea, headache, and electrolyte changes. It also carries warnings for infertility, pregnancy, and breastfeeding[5].

How do technological advancements impact the oral transmucosal drugs market?

Technological advancements in drug discovery, formulation technologies, and delivery systems have resulted in oral transmucosal drugs that offer improved efficacy, safety, and patient adherence[4].

What is the role of sustainability trends in the oral transmucosal drugs market?

Sustainability trends are influencing the market, with pharmaceutical companies focusing on environmentally friendly production processes and sustainable packaging solutions, driven by regulatory pressures and growing awareness of environmental sustainability[4].

Sources

  1. Grand View Research: Oral Transmucosal Drugs Market Size & Share Report, 2030.
  2. Wikipedia: Fluoxymesterone.
  3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  4. GlobeNewswire: Oral Antiviral Market Research 2024-2025 & 2030.
  5. UPMC Hillman Cancer Center: Fluoxymesterone (Other Names: Halotestin®, Ora-Testryl).

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