DRONABINOL - Generic Drug Details

What are the generic drug sources for dronabinol and what is the scope of freedom to operate?

Dronabinol is the generic ingredient in three branded drugs marketed by Ascent Pharms Inc, Hikma, Insys Therap, Lannett Co Inc, Svc Pharma, Alkem Labs Ltd, and Benuvia Operations, and is included in seven NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dronabinol has four patent family members in four countries.

There are eleven drug master file entries for dronabinol. Nine suppliers are listed for this compound.

Summary for DRONABINOL

International Patents:	4
US Patents:	4
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	106
Patent Applications:	7,208
Drug Prices:	Drug price trends for DRONABINOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DRONABINOL
What excipients (inactive ingredients) are in DRONABINOL?	DRONABINOL excipients list
DailyMed Link:	DRONABINOL at DailyMed

See drug prices for DRONABINOL

Recent Clinical Trials for DRONABINOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Incannex Healthcare Ltd	Phase 2/Phase 3
Corey Hawes	Phase 2/Phase 3
National Center for Advancing Translational Sciences (NCATS)	Phase 2/Phase 3

See all DRONABINOL clinical trials

Pharmacology for DRONABINOL

Drug Class

Cannabinoid

Medical Subject Heading (MeSH) Categories for DRONABINOL

Analgesics, Non-Narcotic

Cannabinoid Receptor Agonists

Hallucinogens

Psychotropic Drugs

Anatomical Therapeutic Chemical (ATC) Classes for DRONABINOL

A04AD	Other antiemetics
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

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
Svc Pharma	DRONABINOL	dronabinol	CAPSULE;ORAL	078292-003	Jun 27, 2008		DISCN	No	No
Svc Pharma	DRONABINOL	dronabinol	CAPSULE;ORAL	078292-002	Jun 27, 2008		DISCN	No	No
Hikma	DRONABINOL	dronabinol	CAPSULE;ORAL	079217-001	Jun 20, 2014		DISCN	No	No
Benuvia Operations	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No			Y	Y
Svc Pharma	DRONABINOL	dronabinol	CAPSULE;ORAL	078292-001	Jun 27, 2008		DISCN	No	No
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-003	May 31, 1985	AB	RX	Yes	No
Hikma	DRONABINOL	dronabinol	CAPSULE;ORAL	079217-002	Jun 20, 2014		DISCN	No	No

Expired US Patents for DRONABINOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-001	May 31, 1985
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-003	May 31, 1985
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-002	May 31, 1985

International Patents for DRONABINOL

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009020666
Canada	2698752	FORMULATIONS LIQUIDES A USAGE ORAL DE CANNABINOIDES ET PROCEDES DE TRAITEMENT AVEC CELLES-CI (ORAL CANNABINOID LIQUID FORMULATIONS AND METHODS OF TREATMENT)
Japan	2010535774
European Patent Office	2184983	FORMULATIONS LIQUIDES À USAGE ORAL DE CANNABINOÏDES ET PROCÉDÉS DE TRAITEMENT AVEC CELLES-CI (ORAL CANNABINOID LIQUID FORMULATIONS AND METHODS OF TREATMENT)

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