Dronabinol - Generic Drug Details
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What are the generic sources for dronabinol and what is the scope of freedom to operate?
Dronabinol
is the generic ingredient in three branded drugs marketed by Ascent Pharms Inc, Hikma, Insys Therap, Lannett Co Inc, Svc Pharma, Alkem Labs Ltd, and Benuvia Operations, and is included in seven NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Dronabinol has four patent family members in four countries.
There are eleven drug master file entries for dronabinol. Nine suppliers are listed for this compound.
Summary for dronabinol
International Patents: | 4 |
US Patents: | 4 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 106 |
Patent Applications: | 7,208 |
Drug Prices: | Drug price trends 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 |
Corey Hawes | Phase 2/Phase 3 |
National Center for Advancing Translational Sciences (NCATS) | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Svc Pharma | DRONABINOL | dronabinol | CAPSULE;ORAL | 078292-002 | Jun 27, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alkem Labs Ltd | MARINOL | dronabinol | CAPSULE;ORAL | 018651-001 | May 31, 1985 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Insys Therap | DRONABINOL | dronabinol | CAPSULE;ORAL | 078501-003 | Aug 19, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Lannett Co Inc | DRONABINOL | dronabinol | CAPSULE;ORAL | 201463-002 | May 18, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Svc Pharma | DRONABINOL | dronabinol | CAPSULE;ORAL | 078292-001 | Jun 27, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Insys Therap | DRONABINOL | dronabinol | CAPSULE;ORAL | 078501-002 | Aug 19, 2011 | 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 |
Expired US Patents for dronabinol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Alkem Labs Ltd | MARINOL | dronabinol | CAPSULE;ORAL | 018651-001 | May 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Alkem Labs Ltd | MARINOL | dronabinol | CAPSULE;ORAL | 018651-003 | May 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Alkem Labs Ltd | MARINOL | dronabinol | CAPSULE;ORAL | 018651-002 | May 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dronabinol
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
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 |
Japan | 2010535774 | ⤷ 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 |
World Intellectual Property Organization (WIPO) | 2009020666 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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