SYNDROS Drug Patent Profile
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When do Syndros patents expire, and when can generic versions of Syndros launch?
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 SVC PHARMA on June 27th, 2008.
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: | 2 |
Patent Applications: | 3,564 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for SYNDROS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jeffrey L Gum MD | Phase 4 |
University of Arizona | Early Phase 1 |
Pharmacology for SYNDROS
Drug Class | Cannabinoid |
Anatomical Therapeutic Chemical (ATC) Classes for SYNDROS
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 |
---|---|---|---|
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 |
Japan | 2010535774 | ⤷ Try a Trial | |
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 |
>Country | >Patent Number | >Title | >Estimated Expiration |