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Last Updated: November 29, 2023

SYNDROS Drug Patent Profile


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Which patents cover Syndros, and what generic alternatives are available?

Syndros is a drug marketed by Benuvia Operations and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

The generic ingredient in SYNDROS is dronabinol. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dronabinol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Syndros

A generic version of SYNDROS was approved as dronabinol by SVC PHARMA on June 27th, 2008.

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Drug patent expirations by year for SYNDROS
Drug Prices for SYNDROS

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Recent Clinical Trials for SYNDROS

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

SponsorPhase
Jeffrey L Gum MDPhase 4
University of ArizonaEarly Phase 1

See all SYNDROS clinical trials

Pharmacology for SYNDROS
Drug ClassCannabinoid
Paragraph IV (Patent) Challenges for SYNDROS
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 SYNDROS

SYNDROS is protected by four US patents.

Patents protecting SYNDROS

Oral cannabinoid formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Oral cannabinoid formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liquid cannabinoid formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Oral cannabinoid formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Benuvia Operations SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Benuvia Operations SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Benuvia Operations SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Benuvia Operations SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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

International Patents for SYNDROS

See the table below for patents covering SYNDROS around the world.

Country Patent Number Title Estimated Expiration
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
Japan 2010535774 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009020666 ⤷  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
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Moodys
McKinsey
Harvard Business School
Baxter

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