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Last Updated: March 28, 2024

CANNABIDIOL - Generic Drug Details


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What are the generic sources for cannabidiol and what is the scope of patent protection?

Cannabidiol is the generic ingredient in one branded drug marketed by Jazz Pharms Res and is included in one NDA. There are twenty-nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cannabidiol has one hundred and forty-six patent family members in twenty-five countries.

There are nine drug master file entries for cannabidiol. One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CANNABIDIOL
Generic Entry Date for CANNABIDIOL*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CANNABIDIOL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sheppard Pratt Health SystemPhase 2
University of Maryland, BaltimorePhase 2
University of MarylandPhase 2

See all CANNABIDIOL clinical trials

Paragraph IV (Patent) Challenges for CANNABIDIOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPIDIOLEX Oral Solution cannabidiol 100 mg/mL 210365 10 2022-09-28

US Patents and Regulatory Information for CANNABIDIOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms Res EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jazz Pharms Res EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Jazz Pharms Res EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for CANNABIDIOL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Jazz Pharmaceuticals Ireland Limited Epidyolex cannabidiol EMEA/H/C/004675
Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.
Authorised no no yes 2019-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CANNABIDIOL

Country Patent Number Title Estimated Expiration
Mexico 2017004762 USO DE CANNABINOIDES EN EL TRATAMIENTO DE EPILEPSIA. (USE OF CANNABINOIDS IN THE TREATMENT OF EPILEPSY.) ⤷  Try a Trial
Japan 2022066354 癲癇の治療におけるカンナビノイドの使用 ⤷  Try a Trial
Australia 2022209295 Use of cannabidiols in the treatment of epilepsy ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.