DRONABINOL Drug Patent Profile
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Which patents cover Dronabinol, and what generic alternatives are available?
Dronabinol is a drug marketed by Ascent Pharms Inc, Hikma, Insys Therap, Lannett Co Inc, and Svc Pharma. and is included in five NDAs.
The generic ingredient in DRONABINOL 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 Dronabinol
A generic version of DRONABINOL was approved as dronabinol by SVC PHARMA on June 27th, 2008.
Summary for DRONABINOL
US Patents: | 0 |
Applicants: | 5 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 103 |
Patent Applications: | 4,523 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DRONABINOL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DRONABINOL |
What excipients (inactive ingredients) are in DRONABINOL? | DRONABINOL excipients list |
DailyMed Link: | DRONABINOL at DailyMed |
Recent Clinical Trials for DRONABINOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ralph H. Johnson VA Medical Center | Phase 2 |
JHSPH Center for Clinical Trials | Phase 2 |
University of California, Los Angeles | Phase 1 |
Pharmacology for DRONABINOL
Drug Class | Cannabinoid |
Medical Subject Heading (MeSH) Categories for DRONABINOL
Anatomical Therapeutic Chemical (ATC) Classes for DRONABINOL
Paragraph IV (Patent) Challenges for DRONABINOL
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 DRONABINOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ascent Pharms Inc | DRONABINOL | dronabinol | CAPSULE;ORAL | 207421-001 | Feb 7, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Insys Therap | DRONABINOL | dronabinol | CAPSULE;ORAL | 078501-001 | Aug 19, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | DRONABINOL | dronabinol | CAPSULE;ORAL | 079217-001 | Jun 20, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lannett Co Inc | DRONABINOL | dronabinol | CAPSULE;ORAL | 201463-003 | May 18, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |