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 ASCENT PHARMS INC on February 7th, 2020.
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Questions you can ask:
- What is the 5 year forecast for DRONABINOL?
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- 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: | 106 |
| Patent Applications: | 4,312 |
| 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 |
|---|---|
| Incannex Healthcare Ltd | Phase 2/Phase 3 |
| National Center for Advancing Translational Sciences (NCATS) | Phase 2/Phase 3 |
| Corey Hawes | Phase 2/Phase 3 |
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 |
