EPIDIOLEX Drug Patent Profile
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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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for EPIDIOLEX?
- What are the global sales for EPIDIOLEX?
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EPIDIOLEX
Generic Entry Date for EPIDIOLEX*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
---|---|
Food and Drug Administration (FDA) | Phase 1 |
Spaulding Clinical Research LLC | Phase 1 |
Incannex Healthcare Ltd | Phase 2 |
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EPIDIOLEX is ⤷ Subscribe.
This potential generic entry date is based on patent 11,207,292.
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 | 10,918,608 | ⤷ Subscribe | ⤷ Subscribe | ||||
Jazz Pharms Res | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | 11,065,209 | ⤷ Subscribe | ⤷ Subscribe | ||||
Jazz Pharms Res | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | 11,400,055 | ⤷ Subscribe | ⤷ Subscribe | ||||
Jazz Pharms Res | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | 11,446,258 | ⤷ Subscribe | ⤷ Subscribe | ||||
Jazz Pharms Res | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | 11,096,905 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | 10,195,159 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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
Patent: 19259230
Patent: Cannabidiol preparations and its uses
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2020021884
Patent: preparações de canabidiol.
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 97665
Patent: PREPARATIONS DE CANNABIDIOL ET LEURS UTILISATIONS (CANNABIDIOL PREPARATIONS AND ITS USES)
Estimated Expiration: ⤷ Subscribe
China
Patent: 2512585
Patent: 大麻二酚制品及其用途 (CANNABIDIOL PREPARATIONS AND ITS USES)
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 2092582
Patent: ПРЕПАРАТЫ КАННАБИДИОЛА И ИХ ПРИМЕНЕНИЕ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 84283
Patent: PRÉPARATIONS DE CANNABIDIOL ET LEURS UTILISATIONS (CANNABIDIOL PREPARATIONS AND ITS USES)
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 8224
Patent: תכשירים של קנאבידיאול ושימושים שלהם (Cannabidiol preparations and its uses)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 21522261
Patent: カンナビジオール製剤及びその使用
Estimated Expiration: ⤷ Subscribe
Patent: 24038127
Patent: カンナビジオール製剤及びその使用
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 20011163
Patent: PREPARACIONES DE CANNABIDIOL Y SUS USOS. (CANNABIDIOL PREPARATIONS AND ITS USES.)
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 210005128
Patent: 칸나비디올 제제 및 이의 용도
Estimated Expiration: ⤷ Subscribe
United Kingdom
Patent: 74321
Patent: Cannabidiol preparations
Estimated Expiration: ⤷ Subscribe
Patent: 1806953
Estimated Expiration: ⤷ Subscribe
Patent: 1905876
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Mexico | 2023003337 | ⤷ Subscribe | |
Australia | 2021201510 | Use of cannabidiol in the treatment of epilepsy | ⤷ Subscribe |
Japan | 2022066354 | ⤷ Subscribe | |
Japan | 2018521042 | ⤷ Subscribe | |
Israel | 296865 | שימוש בקנבינואידים בטיפול באפילפסיה (Use of cannabinoids in the treatment of epilepsy) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
EPIDIOLEX Market Analysis and Financial Projection Experimental
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