Cannabidiol - Generic Drug Details

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

Cannabidiol is the generic ingredient in one branded drug marketed by Jazz Pharms Res and is included in one NDA. There are thirty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cannabidiol has one hundred and sixty-nine patent family members in twenty-seven countries.

There are nine drug master file entries for cannabidiol. One supplier is listed for this compound.

Summary for cannabidiol

International Patents:	169
US Patents:	32
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	414
Patent Applications:	6,839
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cannabidiol
What excipients (inactive ingredients) are in cannabidiol?	cannabidiol excipients list
DailyMed Link:	cannabidiol at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cannabidiol

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for cannabidiol

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

Sponsor	Phase
University of Maryland	Phase 2
Sheppard Pratt Health System	Phase 2
University of Maryland, Baltimore	Phase 2

See all cannabidiol clinical trials

Pharmacology for cannabidiol

Mechanism of Action

Cytochrome P450 1A2 Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors UGT1A9 Inhibitors UGT2B7 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for cannabidiol

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for CANNABIDIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDIOLEX	Oral Solution	cannabidiol	100 mg/mL	210365	10	2022-09-28

US Patents and Regulatory Information for cannabidiol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes

Expired US Patents for cannabidiol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018

EU/EMA Drug Approvals for cannabidiol

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Jazz Pharmaceuticals Ireland Limited	Epidyolex	cannabidiol	EMEA/H/C/004675Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.	Authorised	no	no	yes	2019-09-19

International Patents for cannabidiol

Country	Patent Number	Title	Estimated Expiration
Australia	2024204208
Israel	281793	שימוש בקנבינואידים בטיפול באפילפסיה (Use of cannabinoids in the treatment of epilepsy)
Japan	2020079265	てんかんの治療におけるカンナビジオールの使用 (USE OF CANNABIDIOL IN TREATMENT OF EPILEPSY)
Japan	7238037
Mexico	2020006954
New Zealand	765231	Use of cannabidiol in the treatment of epilepsy
Spain	2680656

Market Dynamics and Financial Trajectory for Cannabidiol (CBD)

Last updated: December 18, 2025

Executive Summary

Cannabidiol (CBD) has emerged as a prominent compound within the expanding autonomous segment of the global pharmaceutical and health & wellness markets. With its versatile therapeutic applications, regulatory shifts, and evolving consumer acceptance, CBD's market trajectory is poised for substantial growth over the next decade. This comprehensive analysis delineates the current landscape, key drivers, market segmentation, challenges, and future outlook—offering stakeholders strategic insights necessary for informed decision-making.

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What Are the Key Market Dynamics Influencing CBD?

1. Regulatory Environment and Legal Status

Global Legal Variability:

Region	Status	Key Milestones	Impact on Market
United States	Legal federally for hemp-derived CBD (since 2018)	Hemp Farming Act of 2018, FDA considerations for medicinal use	Facilitated market entry; No federal ban
European Union	Permissive but with strict THC limits	EU Novel Foods Authorization (2021)	Market expansion; Compliance challenges
Asia-Pacific	Fragmented, with some countries legalizing	Australia, South Korea legal CBD for medicinal purposes	Emerging markets; Market barriers
Others	Varying degrees of restrictions	Variable, often restrictive	Limited growth potential

Implication: Regulatory clarity and alignment are crucial for market expansion. Delays or unfavorable policies constrain supply chains and hinder innovation.

2. Consumer Acceptance and Market Penetration

End-User Demographics:

Segment	Growth Drivers	Challenges
Wellness & Lifestyle	Increasing health consciousness, non-psychoactive nature	Skepticism, misinformation
Medical & Therapeutic	Approved indications (e.g., epilepsy, anxiety)	Regulatory hurdles, limited approved products
Pharmaceuticals	Prescription formulations	Strict clinical trial requirements

Impact: The broader acceptance fuels demand, particularly in wellness and medical applications, fostering a substantial consumer base.

3. Scientific Validity and Research

Key Developments:

Year	Study Focus	Findings
2018	Epilepsy treatment (Epidiolex)	Approved by FDA in 2018; proven efficacy
2020	Anxiety and sleep disorders	Positive outcomes in preliminary trials
2022	Anti-inflammatory effects	Ongoing; early-stage validation

Implication: Evidence-based research underpins regulatory approvals, which directly influence clinical acceptance and insurance coverage policies.

4. Market Drivers

• Rising consumer interest in natural, plant-based solutions.
• Official pharmaceutical approvals boosting credibility.
• Expansion of OTC and prescription CBD formulations.
• Increasing investment from Big Pharma.
• Innovative delivery formats (e.g., topicals, nanoemulsions).

5. Challenges and Barriers

• Regulatory uncertainty and lagging legislation.
• Industry fragmentation and lack of standardization.
• Quality control issues, including adulteration and mislabeled products.
• Limited long-term clinical data for certain indications.
• Intellectual property challenges and patenting issues.

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How Is the Market Segmented and What Are Its Drivers?

Market Segmentation

Segment Type	Subcategories	Market Share (2022, Estimated)	Growth Rate (CAGR 2023-2028)
Product Type	Oils & Tinctures, Edibles, Topicals, Capsules	45%	20%
Application	Medical, Wellness & Lifestyle, Animal Health	30%	19%
Distribution Channel	Retail Pharmacies, E-commerce, Medical Clinics	35%	22%
Geography	North America, Europe, Asia-Pacific, Rest of World	NA	Varies; fastest in APAC

Primary Market Drivers by Segment

Driver	Effect	Evidence/Stats
Regulatory Approvals	Legitimizes use; encourages R&D, manufacturing	FDA approval of Epidiolex (2018)
Consumer Demand	Expanding market for wellness products	CAGR of 22.4%, 2023-2028 [1]
Scientific Validation	Increased clinical acceptance	>200 clinical trials registered [2]
Investment and M&A Activity	Accelerates innovation and market consolidation	$4.2 billion invested globally in 2022 [3]
Product Innovation	Diversifies applications and formulations	Entry of nanoemulsions, transdermal patches

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What Is the Projected Financial Trajectory of CBD?

Market Revenue Forecast (2023–2028)

Year	Global Market Size (USD Billion)	CAGR	Notes
2023	9.5		Base year
2024	11.5	21%	Expansion fueled by legalized markets
2025	14.0	22%	Increasing product launches
2026	17.3	23%	Broader acceptance, new indications
2027	21.0	22%	Market reaches maturity in key regions
2028	25.6	22%	Expected to surpass $25B

Source: Derived from multiple market research reports, including Grand View Research [1], and industry analyses.

Revenue Projections by Segment

Segment	2023 USD Billion	2028 USD Billion	CAGR	Key Drivers
Oils & Tinctures	4.3	10.2	20%	Mainstay product; widespread consumer use
Edibles	2.2	5.2	21%	Preference for convenience; flavor innovations
Topicals	1.4	3.4	20%	Expansion in pain management and skin care
Capsules & Softgels	0.8	1.8	19%	Pharmaceutical integration, ease of dosing

Financial Opportunities and Risks

Opportunities	Risks
Market expansion in Asia-Pacific markets	Regulatory restrictions, market saturation risk
Development of prescription drugs	High R&D costs, lengthy approval cycles
Diversification into novel formulations	Quality assurance challenges, intellectual property risks
Investment in branded products	Market fragmentation, pricing pressures

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How Do Regulatory Policies Influence the Financial Outlook?

Region	Key Policies	Financial Impact
US	FDA-approved cannabinoid-based drugs (e.g., Epidiolex)	Increased investor confidence, product premiums
EU	EU Novel Food authorizations, THC limits	Market access for CBD foods; compliance costs
Canada	Fully legal recreational use since 2018	Rapid market development; opportunity for licensed producers
Asia-Pacific	Varying legal frameworks	Potential for high growth but regulatory risk

Note: The regulatory environment remains a critical determinant of future revenue streams and innovation pipelines.

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How Does CBD Compare to Other Phytochemicals in Healthcare?

Compound	Therapeutic Applications	Regulatory Status	Market Size (2022, USD billion)	Growth Rate (2023-2028)
CBD	Epilepsy, anxiety, inflammation	Legal in many jurisdictions; FDA approval of Epidiolex	$9.5 B (2023)	21% CAGR
THC	Pain, appetite stimulation	Legal for medicinal/recreational use in some regions	N/A	Varies by region
Curcumin	Anti-inflammatory, antioxidant	Supplement status, no FDA approval	~$1 B	10% CAGR
Resveratrol	Cardiovascular health	Dietary supplement	<$1 B	8% CAGR

Implication: CBD's broad applicability and relatively favorable regulatory status position it favorably against other phytochemicals.

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What Are the Future Trends and Innovations?

• Product Diversification: Growth in topical formulations, beverages, transdermal patches, nanoemulsions.
• Personalized Medicine: Use of biomarkers and genetic profiling to tailor CBD treatments.
• Prescription-Grade CBD: Increased approvals for specific indications, fostering new revenue streams.
• Digital and Delivery Platforms: Telemedicine, direct-to-consumer channels, and telepharmacy integration.
• Sustainable and Organic Production: Consumer preference drives adoption of eco-friendly cultivation and extraction methods.

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Key Takeaways

• The CBD market is on a robust growth trajectory, projected to reach over $25 billion globally by 2028.
• Regulatory clarity, particularly in the US and Europe, remains a pivotal factor shaping market expansion.
• Product innovation, from oils to complex formulations, fuels consumer demand and therapeutic applications.
• Investment trends indicate significant confidence, with over $4 billion invested in the industry globally in 2022.
• Challenges such as quality control, regulatory lag, and scientific validation must be addressed to maximize commercial potential.

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FAQs

1. What are the primary factors driving CBD market growth?

Consumer demand for natural health products, regulatory approvals (e.g., FDA's Epidiolex), scientific validation of therapeutic benefits, and product innovation are the main drivers.

2. How do regional regulations affect market opportunities?

Regulatory environments dictate market accessibility, product approvals, and manufacturing standards—regions with clearer, supportive policies see higher growth and investment.

3. What are the key challenges for the CBD industry?

The industry faces regulatory uncertainty, quality assurance issues, lack of standardization, and the need for more extensive long-term clinical data.

4. Which sectors within the CBD market are expected to grow fastest?

OTC products such as oils and edibles are currently dominant, but medical-grade formulations and innovative delivery systems like topicals and transdermal patches are projected to grow rapidly.

5. What is the outlook for pharmaceutical applications of CBD?

The approval of drugs like Epidiolex establishes a foundation for future prescription medicines, opening avenues for more targeted therapeutics with substantial market potential.

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References

[1] Grand View Research. "Cannabidiol Market Size, Share & Trends Analysis Report," 2022.
[2] ClinicalTrials.gov, U.S. National Library of Medicine. "Cannabidiol Clinical Trials," Accessed 2023.
[3] CB Insights. "Global Investment Trends in Cannabinoids and CBD," 2022.

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In conclusion, CBD’s expanding scientific validation, shifting regulatory landscapes, and increasing consumer adoption are setting the stage for an promising financial trajectory. Stakeholders must navigate regional policies, maintain product quality, and invest in R&D to capitalize on this rapidly evolving market.