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Last Updated: December 22, 2024

DRONABINOL Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Dronabinol

A generic version of DRONABINOL was approved as dronabinol by ASCENT PHARMS INC on February 7th, 2020.

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Recent Clinical Trials for DRONABINOL

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SponsorPhase
Incannex Healthcare LtdPhase 2/Phase 3
National Center for Advancing Translational Sciences (NCATS)Phase 2/Phase 3
Corey HawesPhase 2/Phase 3

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Pharmacology for DRONABINOL
Drug ClassCannabinoid
Medical Subject Heading (MeSH) Categories for DRONABINOL
Paragraph IV (Patent) Challenges for DRONABINOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYNDROS Oral Solution dronabinol 5 mg/mL 205525 1 2017-04-17

US Patents and Regulatory Information for DRONABINOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ascent Pharms Inc DRONABINOL dronabinol CAPSULE;ORAL 207421-001 Feb 7, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Insys Therap DRONABINOL dronabinol CAPSULE;ORAL 078501-001 Aug 19, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma DRONABINOL dronabinol CAPSULE;ORAL 079217-001 Jun 20, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett Co Inc DRONABINOL dronabinol CAPSULE;ORAL 201463-003 May 18, 2018 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Insys Therap DRONABINOL dronabinol CAPSULE;ORAL 078501-002 Aug 19, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Svc Pharma DRONABINOL dronabinol CAPSULE;ORAL 078292-002 Jun 27, 2008 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

DRONABINOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dronabinol

Introduction to Dronabinol

Dronabinol, a synthetic form of the naturally occurring cannabinoid THC, is a pharmaceutical drug used primarily for the treatment of chemotherapy-induced nausea and vomiting (CINV) and AIDS-related weight loss. The market for dronabinol is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global dronabinol market was valued at US$ 240.9 million in 2023 and is expected to reach US$ 373.8 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period from 2024 to 2030[1].

Key Drivers of Market Growth

Increasing Prevalence of Cancer and Chemotherapy Use

The rising global incidence of cancer and the increasing use of chemotherapy have driven the demand for effective anti-emetic medications like dronabinol. As more patients undergo chemotherapy, the need for managing CINV has significantly contributed to market growth[4].

Growing Acceptance of Cannabis-Based Therapies

There has been a gradual shift in societal attitudes and legal frameworks regarding the use of cannabis-based therapies for various medical conditions. This growing acceptance has increased the demand for dronabinol and other synthetic cannabinoids[4].

Unmet Medical Needs

The integration of personalized medicine approaches, such as pharmacogenomics and patient-specific dosing strategies, could optimize the therapeutic benefits of dronabinol and enhance its safety profile. This could lead to improved patient outcomes and drive market growth by addressing specific patient needs[4].

Geographical Expansion and Emerging Markets

Europe

Companies like MediPharm Labs have seen significant success in European markets, particularly with the sales of dronabinol. For instance, MediPharm Labs doubled its dronabinol sales in Q2 2024 in the European Union, achieving total sales of $1.9 million year-to-date[2].

Asia-Pacific, Latin America, and Middle East & Africa

Emerging markets in these regions present significant growth opportunities due to changing legal landscapes and increasing healthcare expenditure. However, legal and regulatory barriers in many countries may hinder immediate market growth[4].

Competitive Landscape

The dronabinol market is highly competitive, with a limited number of key players operating in the approved therapeutic areas. Major pharmaceutical companies have established a strong presence, leveraging their expertise in drug development, manufacturing capabilities, and regulatory compliance. Product differentiation, marketing strategies, and the ability to navigate complex legal and regulatory frameworks are crucial for competitive positioning[4].

Financial Performance of Key Players

MediPharm Labs

MediPharm Labs, a significant player in the dronabinol market, reported notable financial improvements in Q2 2024. The company achieved net revenue of $10.3 million, an 8% increase compared to Q2 2023, and a gross profit margin of 33%, significantly up from 8.1% in Q2 2023. Adjusted EBITDA improved substantially, from a negative $949K in Q1 2024 to a negative $124K in Q2 2024, indicating a strong move towards profitability[2].

Innovation and R&D

The development of novel formulations and delivery systems for dronabinol, such as transdermal patches, sublingual formulations, and sustained-release products, is a key area of focus. These innovations aim to improve patient convenience, bioavailability, and therapeutic efficacy, creating new market opportunities and driving product differentiation.

Regulatory Environment

Stringent regulatory requirements and varying legal frameworks across different regions are significant factors influencing the dronabinol market. Companies must navigate these complexities to ensure compliance and market access. For example, MediPharm Labs has successfully expanded its product offerings in Germany, leveraging favourable regulatory changes[2].

Management Commentary and Market Outlook

David Pidduck, CEO of MediPharm Labs, highlighted the company's strategic initiatives and operational efficiencies as key drivers of their positive Q2 results. He expressed optimism about the continued growth in international sales and the progress in innovating non-combustible cannabis formats[2].

Greg Hunter, CFO of MediPharm Labs, noted that Q2 2024 was a significant step towards profitability, with the company on the verge of becoming cash flow positive. He emphasized the strong financial position of the company, with a cash balance of $16 million and less than $3 million in debt at the end of Q2 2024[2].

Future Outlook

The dronabinol market is poised for substantial growth, driven by the increasing acceptance of cannabis-based therapies, the rising incidence of cancer and chemotherapy use, and the exploration of new therapeutic applications. As legal and regulatory landscapes evolve, and societal attitudes toward cannabis-derived compounds become more favorable, the market is expected to witness significant growth and innovation[4].

Key Takeaways

  • The global dronabinol market is projected to grow from US$ 240.9 million in 2023 to US$ 373.8 million by 2030, at a CAGR of 6.4%.
  • Key drivers include the increasing prevalence of cancer, growing acceptance of cannabis-based therapies, and unmet medical needs.
  • Emerging markets in Asia-Pacific, Latin America, and the Middle East & Africa offer significant growth opportunities.
  • Innovation in formulations and delivery systems is crucial for market growth.
  • Regulatory compliance and navigating complex legal frameworks are essential for market success.

FAQs

Q: What is the current market size of the dronabinol market? A: The global dronabinol market was valued at US$ 240.9 million in 2023[1].

Q: What is the projected growth rate of the dronabinol market from 2024 to 2030? A: The dronabinol market is expected to grow at a CAGR of 6.4% from 2024 to 2030[1].

Q: Which factors are driving the growth of the dronabinol market? A: Key drivers include the increasing prevalence of cancer, growing acceptance of cannabis-based therapies, and unmet medical needs[4].

Q: How is MediPharm Labs performing in the dronabinol market? A: MediPharm Labs reported significant financial improvements in Q2 2024, including increased revenue and gross profit margins, and improved Adjusted EBITDA[2].

Q: What are the future outlook and potential innovations in the dronabinol market? A: The market is expected to witness substantial growth driven by new therapeutic applications, innovative formulations, and expansion into emerging markets[4].

Cited Sources

  1. Global Dronabinol Market Research Report 2024 - Valuates Reports
  2. MediPharm Labs Reports Second Quarter Results - Newswire.ca
  3. Cannabidiol/Dronabinol - Drug Targets, Indications, Patents - Synapse
  4. Dronabinol Market Size, Share & Forecast 2033 - Data Horizon Research
  5. MediPharm Labs Reports Second Quarter Results - MediPharm Labs

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