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Generic Epidiolex Availability

Last updated on Oct 6, 2021.

Epidiolex is a brand name of cannabidiol, approved by the FDA in the following formulation(s):

EPIDIOLEX (cannabidiol - solution;oral)

  • 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.

  • Use of cannabinoids in the treatment of epilepsy
    Patent 10,092,525
    Issued: October 9, 2018
    Assignee(s): GW Pharma Limited

    The 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
      ✓ 
      Patent use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME
  • Use of cannabinoids in the treatment of epilepsy
    Patent 10,111,840
    Issued: October 30, 2018
    Assignee(s): GW Pharma Limited

    The 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
      ✓ 
      Patent use: USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH DRAVET SYNDROME
    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
  • Use of cannabinoids in the treatment of epilepsy
    Patent 10,137,095
    Issued: November 27, 2018
    Assignee(s): GW Pharma Limited

    The 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
      ✓ 
      Patent use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
    • June 17, 2035
      ✓ 
      Patent use: USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME
  • 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 Limited

    Processes 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
      ✓ 
      Drug substance
  • Patent 10,603,288

    Patent expiration dates:

    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
    • June 17, 2035
      ✓ 
      Patent use: USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH LENNOX GASTAUT SYNDROME
    • June 17, 2035
      ✓ 
      Patent use: USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH DRAVET SYNDROME
  • Patent 10,709,671

    Patent expiration dates:

    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME
  • Patent 10,709,673

    Patent expiration dates:

    • June 17, 2035
      ✓ 
      Drug product
  • Patent 10,709,674

    Patent expiration dates:

    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
  • Patent 10,849,860

    Patent expiration dates:

    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME
    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
  • Patent 10,918,608

    Patent expiration dates:

    • October 14, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF GENERALIZED SEIZURES OR FOCAL SEIZURES WITH IMPAIRMENT IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
    • October 14, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
    • October 14, 2035
      ✓ 
      Patent use: USE FOR REDUCING SEIZURE FREQUENCY IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
  • Patent 10,966,939

    Patent expiration dates:

    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
      ✓ 
      Drug product
    • June 17, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
      ✓ 
      Drug product
  • Patent 11,065,209

    Patent expiration dates:

    • October 14, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
  • Patent 11,096,905

    Patent expiration dates:

    • October 14, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 14, 2035
      ✓ 
      Patent use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Use of cannabinoids in the treatment of epilepsy
    Patent 9,949,937
    Issued: April 24, 2018
    Assignee(s): GW Pharma Limited

    The 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
      ✓ 
      Patent use: USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
  • Use of cannabinoids in the treatment of epilepsy
    Patent 9,956,183
    Issued: May 1, 2018
    Assignee(s): GW Pharma Limited

    The 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
      ✓ 
      Patent use: USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM
    • June 17, 2035
      ✓ 
      Patent use: USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM
  • Use of cannabinoids in the treatment of epilepsy
    Patent 9,956,184
    Issued: May 1, 2018
    Assignee(s): GW Pharma Limited

    The 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
      ✓ 
      Patent use: USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME
  • Use of cannabinoids in the treatment of epilepsy
    Patent 9,956,185
    Issued: May 1, 2018
    Assignee(s): GW Pharma Limited

    The 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
      ✓ 
      Patent use: USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH DRAVET SYNDROME
  • Use of cannabinoids in the treatment of epilepsy
    Patent 9,956,186
    Issued: May 1, 2018
    Assignee(s): GW Pharma Limited

    The 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
      ✓ 
      Patent use: USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME

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 -
    • July 31, 2027 -
    • July 31, 2027 -

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.