Epidiolex is a drug owned by Jazz Pharmaceuticals Research Uk Ltd. It is protected by 34 US drug patents filed from 2018 to 2026. Out of these, 33 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 Sep 24, 2042. 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. | |||
| US11865102 | Cannabidiol preparations and its uses |
Apr, 2039
(12 years from now) | Active |
| US11207292 | Cannabidiol preparations and its uses |
Apr, 2039
(12 years from now) | Active |
| US11096905 | Use of cannabinoids in the treatment of epilepsy |
Oct, 2035
(9 years from now) | Active |
| US10195159 | Processes and apparatus for extraction of active substances and enriched extracts from natural products |
May, 2022
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12661365 | Use Of Cannabidiol In The Treatment Of Epilepsy |
Sep, 2042
(15 years from now) | Active |
| US11406623 | Methods of treating tuberous sclerosis complex with cannabidiol and everolimus |
Mar, 2041
(14 years from now) | Active |
| US11160795 | Methods of treating tuberous sclerosis complex with cannabidiol and everolimus |
Mar, 2041
(14 years from now) | Active |
| US12102619 | Methods of treating tuberous sclerosis complex with cannabidiol and everolimus |
Mar, 2041
(14 years from now) | Active |
| US10918608 | Use of cannabidiol in the treatment of epilepsy |
Oct, 2035
(9 years from now) | Active |
| US11065209 | Use of cannabidiol in the treatment of epilepsy |
Oct, 2035
(9 years from now) | Active |
| US11400055 | Use of cannabidiol in the treatment of epilepsy |
Oct, 2035
(9 years from now) | Active |
| US11766411 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10709673 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US11154516 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10849860 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10966939 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US11701330 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US9956186 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10092525 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US9949937 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US11633369 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10709671 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10137095 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10709674 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US11311498 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10603288 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US9956183 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US9956184 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US11963937 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US9956185 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US12064399 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US10111840 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US11446258 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 years from now) | Active |
| US11357741 | Use of cannabinoids in the treatment of epilepsy |
Jun, 2035
(8 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 | 04 Mar, 2026 | US11446258 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Jan, 2026 | US11406623 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Jan, 2026 | US11400055 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Nov, 2025 | US11357741 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Oct, 2025 | US9956184 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Oct, 2025 | US9956185 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Oct, 2025 | US9956183 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Oct, 2025 | US9956186 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Oct, 2025 | US11311498 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Oct, 2025 | US9949937 |
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 3 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
Clinical Trials
Recent Clinical Trials on Epidiolex:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Evaluation of Oral THC and CBD in Men and Women | University of California, Los Angeles | NA | RECRUITING
(Sep 1, 2026) | PHASE1 |
| Cannabis (THC vs. CBD) in Multiple Sclerosis | University of Calgary | NA | RECRUITING
(Sep 1, 2026) | PHASE2 |
| Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder | Centre for Addiction and Mental Health | NA | ACTIVE NOT RECRUITING
(Sep 1, 2026) | PHASE2 |
| CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury | University of Wisconsin, Madison | NA | RECRUITING
(Sep 1, 2026) | PHASE2 |
| A Study Testing the Safety and Effects of Single Doses of S1-221 in Healthy Volunteers | Delphian Therapeutics Australia Pty, Ltd | NA | COMPLETED
(Sep 1, 2026) | PHASE1 |
| Study of Cannabidiol and Neuroimaging on Stress | Icahn School of Medicine at Mount Sinai | NA | RECRUITING
(Sep 1, 2026) | PHASE1, PHASE2 |
| The Pharmacokinetics of a Hemp-Based Topical Product | Johns Hopkins University | NA | RECRUITING
(Sep 1, 2026) | PHASE1 |
| Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome | Johns Hopkins University | NA | NOT YET RECRUITING
(Sep 1, 2026) | PHASE2 |
| Oral and Topical Phytocannabinoids for Psoriasis | Federal University of Latin American Integration | NA | ACTIVE NOT RECRUITING
(Sep 1, 2026) | PHASE2 |
| RCT of CBD for Anxiety in Advanced Breast Cancer | Dana-Farber Cancer Institute | NA | ACTIVE NOT RECRUITING
(Aug 1, 2026) | PHASE2 |
| Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome | Harmony Biosciences Management, Inc. | NA | COMPLETED
(Aug 1, 2026) | PHASE3 |
| Life's End Benefits of cannaBidiol and tetrahYdrocannabinol | University of Southern California | NA | COMPLETED
(Aug 1, 2026) | PHASE2 |
| Role of CBD in Improving Alexithymia | University of California, San Diego | NA | TERMINATED
(Aug 1, 2026) | PHASE2 |
| Topical CBD Scar Healing Study | University of Oklahoma | NA | RECRUITING
(Aug 1, 2026) | PHASE1 |
| Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome | Université de Sherbrooke | NA | RECRUITING
(Aug 1, 2026) | PHASE2 |
| Warrior CARE: Cannabis Behavioral Health | Wayne State University | NA | RECRUITING
(Aug 1, 2026) | PHASE1, PHASE2 |
| Unique Treatment of Oncology Pain in Advanced Cancer | ZYUS Life Sciences Inc. | NA | COMPLETED
(Aug 1, 2026) | PHASE2 |
| Stratification and Treatment in Early Psychosis Study - ENHANCE | University of Oxford | NA | RECRUITING
(Aug 1, 2026) | PHASE3 |
| Effects of Cannabidiol on Stress and Nicotine Withdrawal | Johns Hopkins University | NA | RECRUITING
(Aug 1, 2026) | PHASE1 |
| Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving | Johns Hopkins University | NA | NOT YET RECRUITING
(Aug 1, 2026) | PHASE2, PHASE3 |
| A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures | Jazz Pharmaceuticals | NA | RECRUITING
(Aug 1, 2026) | PHASE1 |
| Cannabidiol for Pain Relief of Patients With End-stage mCRPC | Regionshospital Nordjylland | NA | RECRUITING
(Aug 1, 2026) | PHASE2 |
| A Double-Blinded Study on Rapid and Sustained Pain Relief Topical Cannabidiol for Plantar Fasciitis | University of Florida | NA | NOT YET RECRUITING
(Aug 1, 2026) | PHASE2 |
| Full-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in Women | Associação Pan-Americana Multidisciplinar de Endocanabinologia | NA | NOT YET RECRUITING
(Aug 1, 2026) | PHASE2 |
| Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee | Steven E Harte, PhD | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults | University of Nebraska | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype | Tiffany J. Braley, MD, MS | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| Cannabidiol Medication Intervention Trial | Sunnybrook Health Sciences Centre | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis | Mclean Hospital | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer | City of Hope Medical Center | NA | SUSPENDED
(Jul 1, 2026) | PHASE2 |
| Combined THC and CBD for OUD and Chronic Pain | Yale University | NA | RECRUITING
(Jul 1, 2026) | PHASE2 |
| CBD Supplementation in Brazilian Jiu-Jitsu Athletes | Associação Pan-Americana Multidisciplinar de Endocanabinologia | NA | NOT YET RECRUITING
(Jul 1, 2026) | PHASE2, PHASE3 |
| Cannabidiol Oil for Treatment-Resistant Major Depression | Universidade do Sul de Santa Catarina | NA | RECRUITING
(Jul 1, 2026) | PHASE1, PHASE2 |
| Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain | Staci Gruber, Ph.D. | NA | RECRUITING
(Jul 1, 2026) | PHASE1, PHASE2 |
| Epidiolex in Obsessive Compulsive Disorder and Related Disorders | University of Chicago | NA | COMPLETED
(Jun 1, 2026) | PHASE2 |
| Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis | NYU Langone Health | NA | RECRUITING
(Jun 1, 2026) | PHASE2, PHASE3 |
| Cannabidiol for Reducing Drinking in Alcohol Use Disorder | Hôpital le Vinatier | NA | TERMINATED
(Jun 1, 2026) | PHASE2 |
| Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis | Cardiol Therapeutics Inc. | NA | COMPLETED
(Jun 1, 2026) | PHASE2 |
| Alcohol Use Disorder and Cannabidiol | University of Colorado, Denver | NA | RECRUITING
(Jun 1, 2026) | PHASE2, PHASE3 |
| CANnabinoids in Pediatric ONCology | University of Manitoba | NA | RECRUITING
(Jun 1, 2026) | PHASE1, PHASE2 |
| CBD for Individuals at Risk for Alzheimer's Disease | University of Colorado, Denver | NA | RECRUITING
(Jun 1, 2026) | PHASE2 |
| Study of Cannabidiol in Sanfilippo Syndrome | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | NA | RECRUITING
(Jun 1, 2026) | PHASE2, PHASE3 |
| Efficacy and Tolerance of THC 25: CBD 25 in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study | University Hospital, Brest | NA | NOT YET RECRUITING
(Jun 1, 2026) | PHASE2 |
| CANnabinoids for Drug Resistant Epilepsy (DRE) in Adults and Children | University of Manitoba | NA | NOT YET RECRUITING
(Jun 1, 2026) | PHASE2 |
| Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use | University of Colorado, Boulder | NA | NOT YET RECRUITING
(Jun 1, 2026) | PHASE2 |
| Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials | UMC Utrecht | NA | RECRUITING
(Jun 1, 2026) | PHASE3 |
| Cannabidiol and Prolonged Exposure | VA Office of Research and Development | NA | COMPLETED
(May 1, 2026) | PHASE2 |
| Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS | Zynerba Pharmaceuticals, Inc. | NA | ACTIVE NOT RECRUITING
(May 1, 2026) | PHASE2, PHASE3 |
| Cannabinoids vs. Placebo on Persistent Post-surgical Pain Following TKA: A Pilot RCT | McMaster University | NA | COMPLETED
(May 1, 2026) | PHASE3 |
| Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus | Indiana University | NA | COMPLETED
(May 1, 2026) | PHASE1 |
| MIVetsCan: Cannabidiol (CBD)-Care Trial | Kevin Boehnke | NA | RECRUITING
(May 1, 2026) | PHASE2 |
| CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy | Milton S. Hershey Medical Center | NA | RECRUITING
(May 1, 2026) | PHASE1 |
| Cannabigerol Oil for Adolescents With ADHD (CAN-ADHD) | Universidade do Sul de Santa Catarina | NA | RECRUITING
(May 1, 2026) | PHASE1, PHASE2 |
| nVNS, CBD, and SoC for Persistent Post-Traumatic Headache | American Society of Pain and Neuroscience, Inc. | NA | NOT YET RECRUITING
(May 1, 2026) | PHASE2 |
| Cannabis for the Prophylactic Treatment of Migraine | University of Calgary | NA | RECRUITING
(Apr 1, 2026) | PHASE2 |
| Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV | University of California, San Diego | NA | RECRUITING
(Apr 1, 2026) | PHASE2 |
| Fenfluramine for Adult Dravet Patients | University Health Network, Toronto | NA | TERMINATED
(Apr 1, 2026) | PHASE3 |
| Cannabidiol for Reducing Cigarette Use | University of California, Los Angeles | NA | RECRUITING
(Apr 1, 2026) | PHASE2 |
| Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty | Chad Brummett | NA | RECRUITING
(Apr 1, 2026) | PHASE2 |
| CBD for Pain Following Orthopedic Shoulder Surgery | The Methodist Hospital Research Institute | NA | RECRUITING
(Apr 1, 2026) | PHASE1, PHASE2 |
| Cannabidiol and Cannabis Concentrate Users | University of Colorado, Denver | NA | RECRUITING
(Apr 1, 2026) | PHASE2 |
| Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study | Florida A&M University | NA | RECRUITING
(Apr 1, 2026) | PHASE1, PHASE2 |
| Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders. | Assistance Publique - Hôpitaux de Paris | NA | NOT YET RECRUITING
(Apr 1, 2026) | PHASE2 |
| CBD Knee Osteoarthritis Study | University of Tennessee | NA | NOT YET RECRUITING
(Apr 1, 2026) | PHASE2 |
| Sublingual Cannabidiol for Anxiety | Staci Gruber, Ph.D. | NA | COMPLETED
(Mar 1, 2026) | PHASE2 |
| PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product | Staci Gruber, Ph.D. | NA | RECRUITING
(Mar 1, 2026) | PHASE2 |
| Evaluation of Smoked THC and CBD in Men and Women | University of California, Los Angeles | NA | COMPLETED
(Mar 1, 2026) | PHASE1 |
| Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis | Incannex Healthcare Ltd | NA | TERMINATED
(Mar 1, 2026) | PHASE2 |
| The Effectiveness of CBD and CBN in the Treatment of Facial Pain and Headache of Muscular Origin | Wroclaw Medical University | NA | ENROLLING BY INVITATION
(Mar 1, 2026) | PHASE2, PHASE3 |
| Use of CBD in the Treatment of Anxiety | University of Florida | NA | ACTIVE NOT RECRUITING
(Mar 1, 2026) | PHASE2 |
| Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder | Wayne State University | NA | RECRUITING
(Mar 1, 2026) | PHASE3 |
| Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden | National Cancer Institute, Naples | NA | NOT YET RECRUITING
(Mar 1, 2026) | PHASE2 |
| KF2025#1 Trial: Ketamine, Cannabidiol and Cobicistat Interaction Study | Helsinki University Central Hospital | NA | NOT YET RECRUITING
(Mar 1, 2026) | PHASE1 |
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 Sep 24, 2042 (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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 28 Sep, 2022 | 01 Mar, 2041 | High |
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 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 |