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Last Updated: August 15, 2020

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SYNDROS Drug 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 three patents protecting this drug and two Paragraph IV challenges.

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. Twelve suppliers are listed for this compound. Additional details are available on the dronabinol profile page.

US ANDA 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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Pharmacology for SYNDROS
Drug ClassCannabinoid
Paragraph IV (Patent) Challenges for SYNDROS
Tradename Dosage Ingredient NDA Submissiondate
SYNDROS SOLUTION;ORAL dronabinol 205525 2017-04-17

US Patents and Regulatory Information for SYNDROS

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   Start Trial   Start Trial Y Y   Start Trial
Benuvia SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   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

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Baxter

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