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.
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Questions you can ask:
- What is the 5 year forecast for DRONABINOL?
- What are the global sales for DRONABINOL?
- What is Average Wholesale Price for DRONABINOL?
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: | 4,743 |
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 |
![DRONABINOL drug patent expirations Drug patent expirations by year for DRONABINOL](/p/graph/s/t/DRONABINOL-patent-expirations.png)
![Drug Prices for DRONABINOL](/p/graph/drug-price/DRONABINOL.png)
Recent Clinical Trials for DRONABINOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
JHSPH Center for Clinical Trials | Phase 2 |
Ralph H. Johnson VA Medical Center | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Insys Therap | DRONABINOL | dronabinol | CAPSULE;ORAL | 078501-001 | Aug 19, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | DRONABINOL | dronabinol | CAPSULE;ORAL | 079217-001 | Jun 20, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Lannett Co Inc | DRONABINOL | dronabinol | CAPSULE;ORAL | 201463-003 | May 18, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |