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Last Updated: November 21, 2024

DRONABINOL Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Dronabinol

A generic version of DRONABINOL was approved as dronabinol by ASCENT PHARMS INC on February 7th, 2020.

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Drug patent expirations by year for DRONABINOL
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Recent Clinical Trials for DRONABINOL

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

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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
Ascent Pharms Inc DRONABINOL dronabinol CAPSULE;ORAL 207421-001 Feb 7, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Insys Therap DRONABINOL dronabinol CAPSULE;ORAL 078501-001 Aug 19, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma DRONABINOL dronabinol CAPSULE;ORAL 079217-001 Jun 20, 2014 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

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