Generic Epidiolex Availability
Last updated on Sep 11, 2024.
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: JAZZ PHARMS RES
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
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
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
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
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
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
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 10,603,288
Issued: March 31, 2020
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
Assignee(s): GW Research 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✓
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 10,709,671
Issued: July 14, 2020
Inventor(s): Guy Geoffrey & Wright Stephen & Devinsky Orrin
Assignee(s): GW Research LimitedThe present invention relates to the use of cannabidiol (CBD) in the treatment of focal seizures. In one embodiment the patients suffering from focal seizures are children and young adults. CBD appears particularly effective in reducing focal seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; CDKL5; Neuronal ceroid lipofuscinoses (NCL); febrile infection related epilepsy syndrome (FIRES); Aicardi syndrome and brain abnormalities in comparison to other seizure types. Significantly CBD additionally is very effective in the reduction of a sub-type of focal seizures, focal seizures with impairment.
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 10,709,673
Issued: July 14, 2020
Inventor(s): Guy Geoffrey
Assignee(s): GW Research 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 10,709,674
Issued: July 14, 2020
Inventor(s): Guy Geoffrey & Wright Stephen & Devinsky Orrin
Assignee(s): GW Research 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 10,849,860
Issued: December 1, 2020
Inventor(s): Guy Geoffrey & Wright Stephen & Devinsky Orrin
Assignee(s): GW Research 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 cannabidiol in the treatment of epilepsy
Patent 10,918,608
Issued: February 16, 2021
Inventor(s): Guy Geoffrey & Wright Stephen & Thiele Elizabeth
Assignee(s): GW Research LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the treatment of Tuberous Sclerosis Complex (TSC). In particular the TSC is treatment resistant and is characterised by generalised seizures or focal seizures with impairment. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- October 13, 2035✓
- October 13, 2035✓
- October 13, 2035✓
- October 13, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 10,966,939
Issued: April 6, 2021
Inventor(s): Guy Geoffrey & Wright Stephen & Devinsky Orrin
Assignee(s): GW Research 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 cannabidiol in the treatment of epilepsy
Patent 11,065,209
Issued: July 20, 2021
Inventor(s): Guy Geoffrey & Wright Stephen & Thiele Elizabeth
Assignee(s): GW Research LimitedThe present disclosure relates to the use of cannabidiol (CBD) for the treatment of Tuberous Sclerosis Complex (TSC). In particular the TSC is treatment resistant and is characterised by generalised seizures or focal seizures with impairment. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Patent expiration dates:
- October 13, 2035✓
- October 13, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 11,096,905
Issued: August 24, 2021
Inventor(s): Guy Geoffrey & Wright Stephen & Devinsky Orrin
Assignee(s): GW Research 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:
- October 13, 2035✓✓✓
- October 13, 2035✓✓✓
- October 13, 2035
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Use of cannabinoids in the treatment of epilepsy
Patent 11,154,516
Issued: October 26, 2021
Inventor(s): Guy Geoffrey & Wright Stephen & Devinsky Orrin
Assignee(s): GW Research 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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Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Patent 11,160,795
Issued: November 2, 2021
Inventor(s): Guy Geoffrey & Knappertz Volker & Dunayevich Eduardo & Critchley David
Assignee(s): GW Research LimitedThe present disclosure provides methods of treating tuberous sclerosis complex comprising administering cannabidiol and everolimus.
Patent expiration dates:
- March 1, 2041✓
- March 1, 2041
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Cannabidiol preparations and its uses
Patent 11,207,292
Issued: December 28, 2021
Inventor(s): Guy Geoffrey & Knappertz Volker & Whalley Benjamin & Woolley-Roberts Marie & Brodie James & Lach-Falcone Katarzyna & Sutton Alan & Gray Royston & Rana Rohini Rajyalaxmi
Assignee(s): GW Research LimitedCannabidiol (CBD) is a cannabinoid designated chemically as 2-[(1R,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol. Its empirical formula is CHOand its molecular weight is 314.46. CBD is a cannabinoid that naturally occurs in the L. plant. CBD is a white to pale yellow crystalline solid which is insoluble in water and soluble in organic solvents. The present invention encompasses the surprising recognition that certain CBD preparations which are prepared from a botanical origin are more effective in treating diseases or disorders than preparations of CBD which are synthetic or purified to the extent no other impurities in the form of other cannabinoids are present. Prior CBD compositions have been prepared such that no psychoactive components, e.g., tetrahydrocannabinol (THC), remain in the final CBD preparation. Surprisingly, the absence of such minor impurities reduces the efficacy of CBD treatment. Such CBD preparations are characterized by chemical components and/or funtional properties that distinguish them from prior CBD compositions. One or more components of the preparations described herein provide an unexpectedly synergistic effect when utilized in combination.
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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Use of cannabinoids in the treatment of epilepsy
Patent 11,357,741
Issued: June 14, 2022
Inventor(s): Guy Geoffrey & Wright Stephen & Devinsky Orrin
Assignee(s): GW Research LimitedThe present invention relates to the use of cannabidiol (CBD) in the treatment of focal seizures. In one embodiment the patients suffering from focal seizures are children and young adults. CBD appears particularly effective in reducing focal seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; CDKL5; Neuronal ceroid lipofuscinoses (NCL); febrile infection related epilepsy syndrome (FIRES); Aicardi syndrome and brain abnormalities in comparison to other seizure types. Significantly CBD additionally is very effective in the reduction of a sub-type of focal seizures, focal seizures with impairment.
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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Use of cannabinoids in the treatment of epilepsy
Patent 11,446,258
Issued: September 20, 2022
Inventor(s): Guy Geoffrey & Wright Stephen & Devinsky Orrin
Assignee(s): GW Research 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✓
- June 17, 2035
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Patent 11,633,369
Patent expiration dates:
- June 17, 2035✓✓
- June 17, 2035✓✓
- June 17, 2035✓✓
- June 17, 2035
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Patent 11,701,330
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035✓
- June 17, 2035
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Patent 11,766,411
Patent expiration dates:
- June 17, 2035✓
- June 17, 2035
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Patent 11,865,102
Patent expiration dates:
- April 26, 2039✓✓✓
- April 26, 2039✓✓✓
- April 26, 2039✓✓✓
- April 26, 2039
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Patent 11,963,937
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 9,949,937
Issued: April 24, 2018
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
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
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
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
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
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
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
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
Inventor(s): Guy Geoffrey & Wright Stephen & Mead Alice & Devinsky Orrin
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:
- 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
- October 20, 2026 - INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
- July 31, 2027 - TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (TSC) IN PATIENTS 1 YEAR 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
More about Epidiolex (cannabidiol)
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- Drug class: miscellaneous anticonvulsants
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Patient resources
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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.
