Cannabidiol - Generic Drug Details

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What are the generic drug sources for cannabidiol and what is the scope of freedom to operate?

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

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

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

Summary for cannabidiol

International Patents:	151
US Patents:	31
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	351
Patent Applications:	7,443
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cannabidiol
What excipients (inactive ingredients) are in cannabidiol?	cannabidiol excipients list
DailyMed Link:	cannabidiol at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cannabidiol

Generic Entry Date for cannabidiol^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Sheppard Pratt Health System	Phase 2
University of Maryland, Baltimore	Phase 2
University of Maryland	Phase 2

See all cannabidiol clinical trials

Pharmacology for cannabidiol

Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors UGT1A9 Inhibitors UGT2B7 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for cannabidiol

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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

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Glossary

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

Expired US Patents for cannabidiol

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for cannabidiol

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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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3206715	UTILISATION DE CANNABIDIOL DANS LE TRAITEMENT DE LA SCLÉROSE TUBÉREUSE DE BOURNEVILLE (USE OF CANNABIDIOL IN THE TREATMENT OF TUBEROUS SCLEROSIS COMPLEX)	⤷ Sign Up
Canada	2952858	UTILISATION DE CANNABIDIOL DANS LE TRAITEMENT DE L'EPILEPSIE (USE OF CANNABIDIOL IN THE TREATMENT OF EPILEPSY)	⤷ Sign Up
Japan	6919000		⤷ Sign Up
United Kingdom	201510664		⤷ Sign Up
Denmark	3206716		⤷ Sign Up
Canada	2989779	UTILISATION DE CANNABINOIDES DANS LE TRAITEMENT DE L'EPILEPSIE (USE OF CANNABINOIDS IN THE TREATMENT OF EPILEPSY)	⤷ Sign Up
Japan	6654282		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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