Dronabinol - Generic Drug Details

What are the generic drug sources for dronabinol and what is the scope of patent protection?

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:	1
Clinical Trials:	113
Patent Applications:	7,785
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
Montefiore Medical Center	PHASE3
National Institute on Drug Abuse (NIDA)	PHASE3
Baylor College of Medicine	PHASE2

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	078292-001	Jun 27, 2008		DISCN	No	No
Svc Pharma	DRONABINOL	dronabinol	CAPSULE;ORAL	078292-003	Jun 27, 2008		DISCN	No	No
Lannett Co Inc	DRONABINOL	dronabinol	CAPSULE;ORAL	201463-002	May 18, 2018		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
Canada	2698752
Japan	2010535774
European Patent Office	2184983

Market Dynamics and Financial Trajectory for Dronabinol: An Industry Overview

Last updated: July 27, 2025

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Introduction

Dronabinol, a synthetic THC (tetrahydrocannabinol), is a globally recognized pharmaceutical used primarily for the treatment of nausea and anorexia associated with chemotherapy and AIDS-related weight loss. Its unique positioning within cannabinoid therapeutics and evolving regulatory landscape influence its market dynamics and financial prospects substantially. As of 2023, an in-depth understanding of these forces enables stakeholders to navigate the complex pharmaceutical terrain effectively.

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Regulatory Landscape and Market Access

Dronabinol is approved formally by the U.S. Food and Drug Administration (FDA) under the brand Marinol, with several generic versions emerging subsequently. Its legal status remains nuanced; while FDA-approved, the broader Cannabis sativa plant remains Schedule I under the Controlled Substances Act, complicating clinical research and market expansion in some regions. Legislative shifts, notably in North America and Europe, towards medicinal cannabis legalization bolster Dronabinol's commercial potential, despite its synthetic nature.

The U.S. represents the largest market, propelled by stringent oncology and AIDS care protocols and growing acceptance of cannabinoid-based therapies. In contrast, regulatory hurdles in European markets—where cannabis-derived medications are gaining form—delay widespread adoption but promise long-term growth once approved.

Impact on Market Entry:
Stringent federal regulations in the U.S. have historically limited market expansion but are gradually softening. The recent rescheduling proposals and state-level legalization initiatives could unlock wider access, increasing Dronabinol sales significantly.

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Market Demand and Clinical Use Cases

Dronabinol’s primary indications—chemotherapy-induced nausea and AIDS-related anorexia—have established steady demand. However, with increasing recognition of cannabinoids’ broader clinical applications, including chronic pain, neurological disorders, and substance use disorders, its potential demand spectrum broadens.

Recent literature and clinical trials investigate Dronabinol’s efficacy as part of neuroprotective therapies or in managing opioid dependence, which could catalyze new markets. Nevertheless, competition from FDA-approved cannabinoid products like nabilone and natural cannabis extracts constrains growth.

Trends Influencing Demand:

• Oncology and AIDS: Continued prevalence sustains baseline demand.
• Expanded Therapeutic Areas: Emerging evidence may catalyze off-label use.
• Patient Preference: Growing acceptance of plant-based and synthetic cannabinoids supports sustained interest.

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Competitive Landscape and Market Participants

The market features established players like AbbVie (Marinol), Sun Pharmaceutical (generic versions), and emerging biotech entrants developing novel cannabinoid formulations. The patent landscape, with exclusivity periods influencing pricing strategies, remains critical.

Generic competition significantly impacts revenue streams, pressing branded manufacturers to innovate formulations or seek new indications to maintain market share. Additionally, 'biosimilar' or alternative synthetic cannabinoids could emerge, intensifying market competition.

Market Entry Barriers:
High regulatory requirements, patent expirations, and lobbying efforts shape the competitive environment, requiring strategic collaboration and innovation to succeed.

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Financial Trajectory and Market Projections

Forecasts from industry analysts project a compound annual growth rate (CAGR) of approximately 4-6% for the Dronabinol market over the next five years, driven mostly by North American markets. The overall market size, valued at around USD 250 million in 2022, could reach USD 350-400 million by 2028, based on current growth assumptions.

Key Revenue Drivers:

• Market Penetration: Increased approval for additional indications.
• Pricing Strategies: Premium pricing for novel, patent-protected formulations.
• Regulatory Favorability: Navigation of legislative pathways to streamline approvals.

Potential Challenges:

• Regulatory Hurdles: Stringent control status hampers rapid expansion.
• Market Saturation: As generics enter, profit margins shrink unless differentiated.
• Clinical Evidence: The need for robust data to expand indicating labels.

Investment Outlook:
Pharmaceutical companies focusing on cannabinoid therapeutics are likely to invest in R&D and strategic partnerships, possibly leading to pipeline diversification and enhanced revenue streams.

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Emerging Trends Shaping the Future

• Legislative Changes: Increasing bipartisan support for medicinal cannabis could de-schedule Dronabinol or facilitate broader access.
• Formulation Innovation: Development of novel delivery systems (e.g., transdermal patches, inhalers) could command premium pricing.
• Integration into Broader Therapeutics: Combining Dronabinol with other agents for multimodal therapy presents an upswing opportunity.
• Market Expansion: Entry into emerging markets, facilitated by regional regulatory reform, can diversify revenue streams.

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Key Takeaways

• The Dronabinol market remains stable, with steady demand rooted in existing indications, but potential for growth hinges on regulatory reforms and expanded therapeutic label approvals.
• Competition from generics and alternative cannabinoid therapies exerts downward pressure on pricing, necessitating innovation and differentiation strategies.
• Legislative momentum favoring medicinal cannabinoids, particularly in North America and parts of Europe, offers a promising trajectory for market expansion.
• Financial growth is forecasted to be moderate but steady, with innovative delivery systems and broader indications acting as catalysts.
• Stakeholders should monitor regulatory developments and clinical evidence to mitigate risks and capitalize on emerging opportunities.

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FAQs

1. How does Dronabinol differ from medical cannabis?
Dronabinol is a synthetic isolated THC compound approved for specific indications. Medical cannabis contains a complex mixture of cannabinoids, offering broader spectrum effects but lacking FDA approval for many uses, which affects standardization and safety profiles.

2. What are the primary factors limiting Dronabinol’s market growth?
Regulatory restrictions, patent expirations leading to generic competition, and limited indications restrict growth. Additionally, stigma associated with cannabinoids and the status of cannabis legalization influence adoption.

3. Are there new formulations of Dronabinol on the horizon?
Yes, research into alternative delivery mechanisms like transdermal patches or inhalable forms aims to improve bioavailability and patient compliance, potentially commanding premium prices.

4. How might legislative changes impact the Dronabinol market?
Legal de-scheduling or broader acceptance of medicinal cannabis can facilitate increased prescriptions and research, unlocking new markets and expanding existing uses.

5. What role does clinical research play in shaping Dronabinol’s market trajectory?
Robust clinical data supports label expansion, drives physician confidence, and justifies premium pricing, all critical for sustained market growth.

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Sources:

[1] FDA. Marinol (dronabinol) Prescribing Information. 2022.
[2] Global Market Insights. Cannabinoid Pharmaceuticals Market Size. 2022.
[3] The Cannabis Market Report. 2023.
[4] U.S. DEA. Rescheduling Proposals and Regulatory Updates. 2022.
[5] Industry Analysis. Future Trends in Cannabinoid Therapeutics. 2023.