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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jul, 2024 | US10918608 |
| Email Notification Critical | 21 Jun, 2024 | US11406623 |
| Change in Power of Attorney (May Include Associate POA) Critical | 21 Jun, 2024 | US10092525 |
| Email Notification Critical | 21 Jun, 2024 | US10092525 |
| Email Notification Critical | 21 Jun, 2024 | US11096905 |
| Change in Power of Attorney (May Include Associate POA) Critical | 21 Jun, 2024 | US11406623 |
| Email Notification Critical | 21 Jun, 2024 | US10709673 |
| Change in Power of Attorney (May Include Associate POA) Critical | 21 Jun, 2024 | US10709673 |
| Change in Power of Attorney (May Include Associate POA) Critical | 21 Jun, 2024 | US11096905 |
| Change in Power of Attorney (May Include Associate POA) Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |