Generic Epidiolex Availability
Last updated on Jan 11, 2023.
Epidiolex is a brand name of cannabidiol, approved by the FDA in the following formulation(s):
EPIDIOLEX (cannabidiol - solution;oral)
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Manufacturer: GW RES LTD
Approval date: September 28, 2018
Strength(s): 100MG/ML [RLD]
Has a generic version of Epidiolex been approved?
No. There is currently no therapeutically equivalent version of Epidiolex available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Epidiolex. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Use of cannabinoids in the treatment of epilepsy
Patent 10,092,525
Issued: October 9, 2018
Assignee(s): GW Pharma LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 10,111,840
Issued: October 30, 2018
Assignee(s): GW Pharma LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 10,137,095
Issued: November 27, 2018
Assignee(s): GW Pharma LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Processes and apparatus for extraction of active substances and enriched extracts from natural products
Patent 10,195,159
Issued: February 5, 2019
Assignee(s): GW Pharma LimitedProcesses for preparing extracts of natural products such as plant material, and for preparing purified extracts from crude extracts of natural products, by extraction with hot gas. Apparatus suitable for use in preparing extracts of natural products are also described.
Patent expiration dates:
- May 7, 2022✓
- May 7, 2022
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Patent 10,603,288
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Patent 10,709,671
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Patent 10,709,673
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Patent 10,709,674
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Patent 10,849,860
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Patent 10,918,608
Patent expiration dates:
- October 13, 2035✓
- October 13, 2035✓
- October 13, 2035✓
- October 13, 2035
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Patent 10,966,939
Patent expiration dates:
- June 17, 2035✓✓
- June 17, 2035✓✓
- June 17, 2035
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Patent 11,065,209
Patent expiration dates:
- October 13, 2035✓
- October 13, 2035
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Patent 11,096,905
Patent expiration dates:
- October 13, 2035✓✓✓
- October 13, 2035✓✓✓
- October 13, 2035
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Patent 11,154,516
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Patent 11,160,795
Patent expiration dates:
- March 1, 2041✓
- March 1, 2041
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Patent 11,207,292
Patent expiration dates:
- April 26, 2039✓✓
- April 26, 2039✓✓
- April 26, 2039✓✓
- April 26, 2039
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Patent 11,311,498
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Patent 11,357,741
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Patent 11,400,055
Patent expiration dates:
- October 13, 2035✓
- October 13, 2035
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Patent 11,406,623
Patent expiration dates:
- March 1, 2041✓
- March 1, 2041
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Patent 11,446,258
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 9,949,937
Issued: April 24, 2018
Assignee(s): GW Pharma LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 9,956,183
Issued: May 1, 2018
Assignee(s): GW Pharma LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 9,956,184
Issued: May 1, 2018
Assignee(s): GW Pharma LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 9,956,185
Issued: May 1, 2018
Assignee(s): GW Pharma LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 9,956,186
Issued: May 1, 2018
Assignee(s): GW Pharma LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- July 31, 2023 - NEW PATIENT POPULATION
- September 28, 2023 - NEW CHEMICAL ENTITY
- September 28, 2025 - INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER
- July 31, 2027 - TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS BETWEEN 1 AND 2 YEARS OF AGE
- July 31, 2027 - TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (TSC) IN PATIENTS 1 YEAR OF AGE AND OLDER
More about Epidiolex (cannabidiol)
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- Reviews (1)
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- Latest FDA alerts (2)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous anticonvulsants
- Breastfeeding
- En español
Patient resources
Professional resources
Related treatment guides
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
