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Last Updated: August 12, 2020

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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 Akorn Inc, Ascent Pharms Inc, Insys Therap, Lannett Co Inc, Svc Pharma, Alkem Labs Ltd, and Benuvia, and is included in seven NDAs. There are three 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. Twelve 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
Bionorica SEPhase 2
Charite University, Berlin, GermanyPhase 2
University of WashingtonPhase 4

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 NDA Submissiondate
SYNDROS SOLUTION;ORAL dronabinol 205525 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   Start Trial   Start Trial   Start Trial
Ascent Pharms Inc DRONABINOL dronabinol CAPSULE;ORAL 207421-003 Feb 7, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Akorn Inc DRONABINOL dronabinol CAPSULE;ORAL 079217-001 Jun 20, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Insys Therap DRONABINOL dronabinol CAPSULE;ORAL 078501-003 Aug 19, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc DRONABINOL dronabinol CAPSULE;ORAL 201463-001 May 18, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Insys Therap DRONABINOL dronabinol CAPSULE;ORAL 078501-002 Aug 19, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Benuvia SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start 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 018651-001 May 31, 1985   Start Trial   Start Trial
Alkem Labs Ltd MARINOL dronabinol CAPSULE;ORAL 018651-003 May 31, 1985   Start Trial   Start Trial
Alkem Labs Ltd MARINOL dronabinol CAPSULE;ORAL 018651-002 May 31, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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