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Last Updated: September 25, 2022

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 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

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SponsorPhase
Jeffrey L Gum MDPhase 4
University of ArizonaEarly Phase 1

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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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Oral cannabinoid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid cannabinoid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Oral cannabinoid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Benuvia SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Benuvia SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Benuvia SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
World Intellectual Property Organization (WIPO) 2009020666 See Plans and Pricing
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) See Plans and Pricing
Canada 2698752 FORMULATIONS LIQUIDES A USAGE ORAL DE CANNABINOIDES ET PROCEDES DE TRAITEMENT AVEC CELLES-CI (ORAL CANNABINOID LIQUID FORMULATIONS AND METHODS OF TREATMENT) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Moodys
McKinsey
Harvard Business School
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.