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Last Updated: November 2, 2024

Dronabinol - Generic Drug Details


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What are the generic 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.

Drug Prices for dronabinol

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Recent Clinical Trials for dronabinol

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

SponsorPhase
Incannex Healthcare LtdPhase 2/Phase 3
Corey HawesPhase 2/Phase 3
National Center for Advancing Translational Sciences (NCATS)Phase 2/Phase 3

See all dronabinol clinical trials

Pharmacology for dronabinol
Drug ClassCannabinoid
Medical Subject Heading (MeSH) Categories for dronabinol
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

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
Insys Therap DRONABINOL dronabinol CAPSULE;ORAL 078501-002 Aug 19, 2011 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

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

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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