Epidiolex Patent Expiration

Epidiolex is a drug owned by Jazz Pharmaceuticals Research Uk Ltd. It is protected by 33 US drug patents filed from 2018 to 2024. Out of these, 32 drug patents are active and 1 has expired. Epidiolex's patents have been open to challenges since 28 September, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 01, 2041. Details of Epidiolex's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US11207292 Cannabidiol preparations and its uses
Apr, 2039

(14 years from now)

Active
US11865102 Cannabidiol preparations and its uses
Apr, 2039

(14 years from now)

Active
US11096905 Use of cannabinoids in the treatment of epilepsy
Oct, 2035

(10 years from now)

Active
US10195159 Processes and apparatus for extraction of active substances and enriched extracts from natural products
May, 2022

(2 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US12102619 Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Mar, 2041

(16 years from now)

Active
US11406623 Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Mar, 2041

(16 years from now)

Active
US11160795 Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Mar, 2041

(16 years from now)

Active
US11065209 Use of cannabidiol in the treatment of epilepsy
Oct, 2035

(10 years from now)

Active
US10918608 Use of cannabidiol in the treatment of epilepsy
Oct, 2035

(10 years from now)

Active
US11400055 Use of cannabidiol in the treatment of epilepsy
Oct, 2035

(10 years from now)

Active
US11963937 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US9956185 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10137095 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US11766411 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US11154516 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10849860 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US11311498 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10966939 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US11446258 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US11701330 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10709673 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US9956186 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10092525 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US9949937 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US12064399 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10111840 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US11633369 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10603288 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US11357741 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10709671 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US10709674 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US9956183 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active
US9956184 Use of cannabinoids in the treatment of epilepsy
Jun, 2035

(10 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Epidiolex's patents.

Given below is the list of recent legal activities going on the following patents of Epidiolex.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 17 Jul, 2024 US10918608
Email Notification 21 Jun, 2024 US11406623
Change in Power of Attorney (May Include Associate POA) 21 Jun, 2024 US10092525
Email Notification 21 Jun, 2024 US10092525
Email Notification 21 Jun, 2024 US11096905
Change in Power of Attorney (May Include Associate POA) 21 Jun, 2024 US11406623
Email Notification 21 Jun, 2024 US10709673
Change in Power of Attorney (May Include Associate POA) 21 Jun, 2024 US10709673
Change in Power of Attorney (May Include Associate POA) 21 Jun, 2024 US11096905
Change in Power of Attorney (May Include Associate POA) 21 Jun, 2024 US9956184


FDA has granted several exclusivities to Epidiolex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Epidiolex, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Epidiolex.

Exclusivity Information

Epidiolex holds 6 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Epidiolex's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Jul 31, 2023
New Chemical Entity Exclusivity(NCE) Sep 28, 2023
Orphan Drug Exclusivity(ODE-216) Sep 28, 2025
M(M-270) Oct 20, 2026
Orphan Drug Exclusivity(ODE-326) Jul 31, 2027
Orphan Drug Exclusivity(ODE-332) Jul 31, 2027

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Several oppositions have been filed on Epidiolex's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Epidiolex's generic, the next section provides detailed information on ongoing and past EP oppositions related to Epidiolex patents.

Epidiolex's Oppositions Filed in EPO

Epidiolex has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 29, 2021, by James Poole Limited. This opposition was filed on patent number EP15784111A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP15784111A Apr, 2021 James Poole Limited Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Epidiolex is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Epidiolex's family patents as well as insights into ongoing legal events on those patents.

Epidiolex's Family Patents

Epidiolex has patent protection in a total of 25 countries. It's US patent count contributes only to 25.1% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Epidiolex.

Family Patents

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Generic Launch

Generic Release Date:

Epidiolex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 01, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Epidiolex Generics:

There are no approved generic versions for Epidiolex as of now.

How can I launch a generic of Epidiolex before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Epidiolex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epidiolex's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Epidiolex -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
100 mg/mL 28 Sep, 2022 10 01 Mar, 2041





About Epidiolex

Epidiolex is a drug owned by Jazz Pharmaceuticals Research Uk Ltd. It is used for reducing convulsive seizure frequency in patients with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex. Epidiolex uses Cannabidiol as an active ingredient. Epidiolex was launched by Jazz Pharms Res in 2018.

Approval Date:

Epidiolex was approved by FDA for market use on 28 September, 2018.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Epidiolex is 28 September, 2018, its NCE-1 date is estimated to be 28 September, 2022.

Active Ingredient:

Epidiolex uses Cannabidiol as the active ingredient. Check out other Drugs and Companies using Cannabidiol ingredient

Treatment:

Epidiolex is used for reducing convulsive seizure frequency in patients with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex.

Dosage:

Epidiolex is available in solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
100MG/ML SOLUTION Prescription ORAL


Epidiolex News

Japanese study finds that Jazz's Epidiolex is ineffective in treating treatment-resistant epilepsies despite increasing sales

23 Aug, 2024

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