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Last Updated: May 18, 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
Ralph H. Johnson VA Medical CenterPhase 2
JHSPH Center for Clinical TrialsPhase 2
University of California, Los AngelesPhase 1

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
Alkem Labs Ltd MARINOL dronabinol CAPSULE;ORAL 018651-002 May 31, 1985 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Svc Pharma DRONABINOL dronabinol CAPSULE;ORAL 078292-002 Jun 27, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc DRONABINOL dronabinol CAPSULE;ORAL 207421-003 Feb 7, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma DRONABINOL dronabinol CAPSULE;ORAL 079217-002 Jun 20, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc DRONABINOL dronabinol CAPSULE;ORAL 207421-002 Feb 7, 2020 AB RX No No ⤷  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

Expired US Patents for dronabinol

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

International Patents for dronabinol

Country Patent Number Title Estimated Expiration
Japan 2010535774 ⤷  Try a Trial
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) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009020666 ⤷  Try a Trial
Canada 2698752 FORMULATIONS LIQUIDES A USAGE ORAL DE CANNABINOIDES ET PROCEDES DE TRAITEMENT AVEC CELLES-CI (ORAL CANNABINOID LIQUID FORMULATIONS AND METHODS OF TREATMENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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