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EPIDIOLEX Drug Patent Profile

When do Epidiolex patents expire, and what generic alternatives are available?

Epidiolex is a drug marketed by Jazz Pharms Res and is included in one NDA. There are thirty-two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-three patent family members in twenty-five countries.

The generic ingredient in EPIDIOLEX is cannabidiol. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cannabidiol profile page.

DrugPatentWatch^® Generic Entry Outlook for Epidiolex

Epidiolex was eligible for patent challenges on September 28, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 26, 2039. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for EPIDIOLEX

International Patents:	153
US Patents:	32
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	61
Patent Applications:	6,381
Drug Prices:	Drug price information for EPIDIOLEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIDIOLEX
What excipients (inactive ingredients) are in EPIDIOLEX?	EPIDIOLEX excipients list
DailyMed Link:	EPIDIOLEX at DailyMed

See drug prices for EPIDIOLEX

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

NDA:

210365

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 EPIDIOLEX

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

Sponsor	Phase
Spaulding Clinical Research LLC	Phase 1
Food and Drug Administration (FDA)	Phase 1
Incannex Healthcare Ltd	Phase 2

See all EPIDIOLEX clinical trials

Pharmacology for EPIDIOLEX

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

Paragraph IV (Patent) Challenges for EPIDIOLEX

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 EPIDIOLEX

EPIDIOLEX is protected by fifty-seven US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y

Expired US Patents for EPIDIOLEX

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 EPIDIOLEX

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 EPIDIOLEX

When does loss-of-exclusivity occur for EPIDIOLEX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

South Korea

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EPIDIOLEX around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	295459	שיטות לטיפול בתסביך טרשת קרשית עם קנאבידיאול ואברולימוס (Methods of treating tuberous sclerosis complex with cannabidiol and everolimus)
European Patent Office	3984531
China	1306979
United Kingdom	201410771
European Patent Office	3206715	UTILISATION DE CANNABIDIOL DANS LE TRAITEMENT DE LA SCLÉROSE TUBÉREUSE DE BOURNEVILLE (USE OF CANNABIDIOL IN THE TREATMENT OF TUBEROUS SCLEROSIS COMPLEX)

EPIDIOLEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epidiolex

Introduction

Epidiolex, a cannabis-based medication developed by GW Pharmaceuticals and now part of Jazz Pharmaceuticals, has been a game-changer in the treatment of severe forms of epilepsy, particularly Dravet syndrome and Lennox-Gastaut syndrome. Here, we delve into the market dynamics and financial trajectory of this groundbreaking drug.

Initial Market Success

Since its launch in November 2018, Epidiolex has seen an unprecedented level of adoption. In its first full quarter on the market, the drug generated sales of $33.5 million, more than doubling analyst expectations of $16 million[1].

Patient and Prescriber Uptake

The initial success was driven by a "huge influx" of patients, with over 7,600 patients receiving an Epidiolex prescription and more than 1,900 doctors prescribing the medication within the first few months. This high rate of new-patient acquisition was attributed to pent-up demand from previously diagnosed patients and the implementation of coverage by commercial and state Medicaid programs[1].

Expansion and Growth

Epidiolex has continued to show strong growth over the years. By the second quarter of 2023, its net product sales had increased by 15% year-over-year to $202.2 million[3]. In the third quarter of 2024, the sales further increased by 18% to $251.6 million compared to the same period in 2023[2].

Global Approval and Reach

Epidiolex, also known as Epidyolex outside the U.S., is approved in more than 35 countries. This global approval has significantly expanded its market reach, contributing to its growing sales figures[2].

Market Drivers

Several factors are driving the growth of the Epidiolex market:

Increasing Incidence of Epilepsy

The global rise in epilepsy cases, with approximately 50 million people affected worldwide, is a significant driver. Better diagnostic techniques and environmental triggers are leading to more diagnoses, increasing the demand for effective treatments like Epidiolex[4].

Expanding Research and Development

Ongoing research into cannabinoid-based therapies is vital for the market. Studies exploring broader applications of CBD beyond epilepsy could lead to additional approvals, further increasing demand for Epidiolex[4].

Legislative Changes

Recent legislative shifts favoring the approval and regulation of cannabinoid products have created a favorable environment for Epidiolex. Increased legalization of medical cannabis in various regions encourages investment in cannabinoid studies and product development[4].

Collaboration and Partnerships

The market benefits from collaborations and partnerships within the pharmaceutical industry. These alliances facilitate the development of new formulations and delivery methods, enhancing the therapeutic options available to patients[4].

Financial Performance

Epidiolex has been a financial powerhouse for Jazz Pharmaceuticals:

Revenue Growth

The drug's net product sales have consistently shown double-digit year-over-year growth. For instance, in the second quarter of 2024, Epidiolex/Epidyolex sales grew by 22% year-over-year[5].

Contribution to Total Revenues

Epidiolex, along with other key products like Xywav and Rylaze, contributes significantly to Jazz Pharmaceuticals' total revenues. In the third quarter of 2024, neuroscience revenue, which includes Epidiolex, increased by 8% to $760.9 million[2].

Blockbuster Potential

Epidiolex is on track to achieve blockbuster status, with market size projected to reach $17.5 billion by 2031, growing at a CAGR of 14.6% during the forecast period 2024-2031[4].

Operational Efficiencies

GW Pharmaceuticals and later Jazz Pharmaceuticals have implemented several strategies to enhance the drug's market performance:

Specialty Pharmacies

Increasing the number of specialty pharmacies in the network and reducing the time to fill initial prescriptions have contributed to the drug's rapid adoption[1].

Payer Deals

Payer deals with less restrictive prior authorization requirements have increased the number of adult patients, which in turn has boosted sales due to the weight-based dosage of the drug[1].

Future Outlook

The future looks promising for Epidiolex:

Continued Growth

With ongoing research and favorable legislative changes, the demand for Epidiolex is expected to continue growing. The drug's global reach and expanding therapeutic applications will likely drive further sales increases[4].

Market Expansion

As more countries legalize medical cannabis and as research uncovers broader applications for CBD, the market for Epidiolex is poised to expand significantly[4].

Key Takeaways

• Rapid Adoption: Epidiolex saw a huge influx of patients and prescriptions shortly after its launch.
• Global Approval: Approved in over 35 countries, Epidiolex has a significant global market reach.
• Financial Performance: Consistent double-digit year-over-year growth in sales, contributing substantially to Jazz Pharmaceuticals' revenues.
• Market Drivers: Increasing epilepsy cases, expanding research, and favorable legislative changes are key drivers.
• Future Outlook: Projected to reach $17.5 billion by 2031 with a CAGR of 14.6%.

FAQs

What is Epidiolex used for?

Epidiolex is used for the treatment of severe forms of epilepsy, particularly Dravet syndrome and Lennox-Gastaut syndrome.

How has Epidiolex performed financially since its launch?

Epidiolex has shown strong financial performance, exceeding analyst expectations in its first quarter and continuing to grow with double-digit year-over-year sales increases.

What factors are driving the growth of the Epidiolex market?

The growth is driven by increasing epilepsy cases, expanding research into cannabinoid-based therapies, favorable legislative changes, and collaborations within the pharmaceutical industry.

Is Epidiolex approved globally?

Epidiolex is approved in more than 35 countries, including the U.S. where it is known as Epidiolex, and outside the U.S. where it is known as Epidyolex.

What is the projected market size for Epidiolex by 2031?

The market size for Epidiolex is projected to reach $17.5 billion by 2031, growing at a CAGR of 14.6% during the forecast period 2024-2031.

How has the company optimized the distribution and prescription process for Epidiolex?

The company has increased the number of specialty pharmacies and reduced the time to fill initial prescriptions, which has contributed to the rapid adoption of the drug.

Sources

1. FiercePharma: GW's cannabis drug Epidiolex sees 'huge influx' of patients as new trial success opens for market expansion.
2. PR Newswire: Jazz Pharmaceuticals Announces Third Quarter 2024 Financial Results.
3. Jazz Pharmaceuticals Investor Relations: Jazz Pharmaceuticals Announces Second Quarter 2023 Financial Results and Raises 2023 Full Year Financial Guidance.
4. Verified Market Research: Epidiolex Market Size, Scope, Growth, Trends and Forecast.
5. PR Newswire: Jazz Pharmaceuticals Announces Second Quarter 2024 Financial Results and Updates 2024 Financial Guidance.