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 fifty-three patent family members in twenty-five countries.

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

Summary for cannabidiol

International Patents:	153
US Patents:	32
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	351
Patent Applications:	7,443
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, Baltimore	Phase 2
University of Maryland	Phase 2
Sheppard Pratt Health System	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				Y
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/004675 Epidyolex 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
Hungary	E051071
New Zealand	727511	Use of cannabidiol in the treatment of epilepsy
South Korea	20220147636	칸나비디올 및 에버롤리무스에 의한 복합 결절성 경화증 치료 방법
Japan	2020111610	結節性硬化症の治療におけるカンナビジオールの使用 (USE OF CANNABIDIOL IN TREATMENT OF TUBEROUS SCLEROSIS COMPLEX)

Cannabidiol Market Analysis and Financial Projection Experimental

Cannabidiol (CBD) Market Dynamics and Financial Trajectory

Introduction to Cannabidiol (CBD)

Cannabidiol, or CBD, is a non-psychoactive compound derived from the cannabis plant, gaining significant attention for its therapeutic properties and health benefits. The CBD market has been experiencing rapid growth, driven by various factors including increasing legalization, consumer awareness, and expanding research.

Market Size and Growth Projections

The global cannabidiol market was valued at USD 7.71 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 15.8% from 2024 to 2030, reaching USD 22.05 billion by 2030[1][3]. Another projection indicates that the market could grow by USD 44.56 billion from 2024 to 2028, with a CAGR of almost 23.59% during this period[2].

Key Drivers of Market Growth

Legalization and Regulatory Changes

The legalization of hemp-based products and changes in regulatory frameworks are significant drivers of the CBD market. Regions like North America, particularly the U.S., have seen substantial growth due to the ratification of the U.S. Farm Bill in 2020[3].

Increasing Consumer Awareness and Demand

Rising consumer awareness about the health benefits of CBD, including pain management, anxiety relief, and potential anti-inflammatory effects, is fueling market growth. Consumers are increasingly preferring natural remedies, which has led to a surge in demand for CBD products[4].

E-commerce and Distribution Channels

The rise of e-commerce has enabled companies to reach a wider audience and increase sales through online channels, positively impacting the CBD industry's growth projections[1].

Product Diversification

The market is characterized by a high degree of innovation, with companies developing a variety of CBD products such as edibles, topicals, beverages, oils, tinctures, and more. This diversification caters to different consumer preferences and needs[1][3].

Segment Analysis

Source Type Outlook

The hemp segment dominated the market in 2023, accounting for 55.7% of the revenue. This segment is expected to grow the fastest due to rising demand from the pharmaceutical industry and growing consumer awareness of health benefits[1].

Sales Type Outlook

Business-to-business (B2B) sales accounted for more than 51.5% of total market revenue in 2022, dominating the market. The B2B segment is expected to continue growing profitably over the forecast period[3].

End-use Outlook

The pharmaceutical segment led the market, accounting for more than 72.5% of the revenue in 2022. This segment is anticipated to expand at a profitable rate due to the growing recognition of CBD's medical benefits and its transition from herbal remedies to prescription drugs[3].

Regional Insights

North America, particularly the U.S., leads the CBD market with a revenue share of approximately 86.4% in 2022. The region's large population of health-conscious individuals, growing acceptability of CBD products, and favorable regulatory environment contribute to its dominance[3].

Challenges and Opportunities

High Cost of Products

One of the challenges facing the CBD market is the high cost of CBD products, which can be a barrier to entry for some consumers[2].

Regulatory Environment

The regulatory environment varies significantly across regions, posing compliance challenges and affecting product availability and marketing practices. However, ongoing legalization and regulatory changes are expected to boost market growth[4].

Research and Development

Expanding research on CBD's efficacy and its potential health benefits is driving the market forward. Ongoing studies on how CBD affects various health conditions are expected to increase demand for CBD products in the pharmaceutical sector[3].

Key Market Players

Major players in the CBD market include Aurora Cannabis Inc., Cannabis Science Inc., Cannoid LLC, Canopy Growth Corp., Charlottes Web Holdings Inc., Cronos Group Inc., Elixinol, Endoca BV, Folium Biosciences, and others. These companies are expanding their market presence through strategic partnerships and product diversification[2][3].

Consumer Behavior and Preferences

Consumer behavior is a crucial aspect of the CBD market. Reports indicate that consumers prefer various product types such as oils, edibles, and topicals. Factors influencing purchasing decisions include dosage preferences, brand loyalty, and the perceived health benefits of CBD products[4].

Financial Trajectory

The cannabis industry, which includes the CBD market, has grown significantly over the past few years. For instance, the U.S. cannabis market sold an estimated $38.4 billion in medical and recreational cannabis in 2023, projected to rise to $56.9 billion by 2028[5].

Investment and Capital Flow

The potential for federal legalization in the U.S. is expected to attract significant capital into the industry. Once federal legalization occurs, the influx of capital is anticipated to be substantial, driving further growth and expansion[5].

Conclusion

The cannabidiol market is poised for significant growth driven by legalization, consumer awareness, and product diversification. Despite challenges such as high product costs and regulatory complexities, the market's financial trajectory looks promising. As research continues to uncover the therapeutic benefits of CBD, the market is expected to expand rapidly across various sectors.

Key Takeaways

• The global CBD market is projected to grow significantly, reaching USD 22.05 billion by 2030.
• Legalization and regulatory changes are key drivers of market growth.
• The hemp segment dominates the market and is expected to grow the fastest.
• B2B sales and the pharmaceutical segment are significant contributors to market revenue.
• North America leads the market, driven by a health-conscious population and favorable regulations.
• High product costs and regulatory challenges are notable barriers.

Frequently Asked Questions (FAQs)

1. What is the current size of the global cannabidiol market?

The global cannabidiol market was valued at USD 7.71 billion in 2023[1].

2. What is the expected growth rate of the CBD market from 2024 to 2030?

The CBD market is expected to grow at a CAGR of 15.8% from 2024 to 2030[1].

3. Which segment dominates the CBD market?

The hemp segment dominates the CBD market, accounting for 55.7% of the revenue in 2023[1].

4. What are the key drivers of the CBD market growth?

Key drivers include legalization and regulatory changes, increasing consumer awareness, and the rise of e-commerce[1][2][4].

5. Which region leads the CBD market?

North America, particularly the U.S., leads the CBD market with a revenue share of approximately 86.4% in 2022[3].

Cited Sources:

1. Grand View Research - Cannabidiol Market Size And Share Analysis Report, 2030
2. PR Newswire - Cannabidiol (CBD) Market size is set to grow by USD 44.56 billion from 2024-2028
3. GlobeNewswire - Cannabidiol Market Size 2023-2030: Global Analysis by Type, Product, Sales, Region, Competitive Landscape, End-Use Outlook, Overview, Supply and Demand Side Analysis
4. Morning Ag Clips - Vantage Market Research: Cannabidiol (CBD) Market Growing at CAGR 21.20%
5. CFO Brew - Cannabis: a new career path for finance professionals