DRONABINOL - Generic Drug Details

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

Dronabinol is the generic ingredient in three branded drugs marketed by Ascent Pharms Inc, Hikma, Insys Therap, Lannett Co Inc, Svc Pharma, Alkem Labs Ltd, and Benuvia Operations, and is included in seven NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dronabinol has four patent family members in four countries.

There are eleven drug master file entries for dronabinol. Nine suppliers are listed for this compound.

Summary for DRONABINOL

International Patents:	4
US Patents:	4
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	106
Patent Applications:	7,208
Drug Prices:	Drug price trends for DRONABINOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DRONABINOL
What excipients (inactive ingredients) are in DRONABINOL?	DRONABINOL excipients list
DailyMed Link:	DRONABINOL at DailyMed

See drug prices for DRONABINOL

Recent Clinical Trials for DRONABINOL

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

Sponsor	Phase
Incannex Healthcare Ltd	Phase 2/Phase 3
Corey Hawes	Phase 2/Phase 3
National Center for Advancing Translational Sciences (NCATS)	Phase 2/Phase 3

See all DRONABINOL clinical trials

Pharmacology for DRONABINOL

Drug Class	Cannabinoid

Medical Subject Heading (MeSH) Categories for DRONABINOL

Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Hallucinogens
Psychotropic Drugs

Anatomical Therapeutic Chemical (ATC) Classes for DRONABINOL

A04AD	Other antiemetics
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DRONABINOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYNDROS	Oral Solution	dronabinol	5 mg/mL	205525	1	2017-04-17

US Patents and Regulatory Information for DRONABINOL

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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
Svc Pharma	DRONABINOL	dronabinol	CAPSULE;ORAL	078292-002	Jun 27, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-001	May 31, 1985	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Insys Therap	DRONABINOL	dronabinol	CAPSULE;ORAL	078501-003	Aug 19, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett Co Inc	DRONABINOL	dronabinol	CAPSULE;ORAL	201463-002	May 18, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Svc Pharma	DRONABINOL	dronabinol	CAPSULE;ORAL	078292-001	Jun 27, 2008		DISCN	No	No	⤷ 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 DRONABINOL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-001	May 31, 1985	⤷ Sign Up	⤷ Sign Up
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-003	May 31, 1985	⤷ Sign Up	⤷ Sign Up
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-002	May 31, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for DRONABINOL

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2184983	FORMULATIONS LIQUIDES À USAGE ORAL DE CANNABINOÏDES ET PROCÉDÉS DE TRAITEMENT AVEC CELLES-CI (ORAL CANNABINOID LIQUID FORMULATIONS AND METHODS OF TREATMENT)	⤷ Sign Up
Japan	2010535774		⤷ Sign Up
Canada	2698752	FORMULATIONS LIQUIDES A USAGE ORAL DE CANNABINOIDES ET PROCEDES DE TRAITEMENT AVEC CELLES-CI (ORAL CANNABINOID LIQUID FORMULATIONS AND METHODS OF TREATMENT)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2009020666		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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