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. Nine 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 ASCENT PHARMS INC on February 7^th, 2020.

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Summary for SYNDROS

International Patents:	4
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	3
Patent Applications:	5,921
Drug Prices:	Drug price information for SYNDROS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNDROS
What excipients (inactive ingredients) are in SYNDROS?	SYNDROS excipients list
DailyMed Link:	SYNDROS at DailyMed

Drug patent expirations by year for SYNDROS

Recent Clinical Trials for SYNDROS

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

Sponsor	Phase
National Institute on Drug Abuse (NIDA)	Phase 1
Yale University	Phase 1
Jeffrey L Gum MD	Phase 4

See all SYNDROS clinical trials

Pharmacology for SYNDROS

Drug Class	Cannabinoid

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Liquid cannabinoid formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Oral cannabinoid formulations
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Patent Expiration: ⤷ Sign Up

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Glossary

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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		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Benuvia Operations	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Benuvia Operations	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Benuvia Operations	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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.

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