NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 5 pharmaceutical companies such as INSYS THERAP, HIKMA, BENUVIA OPERATIONS and others. It is marketed under 2 brand names, including DRONABINOL, SYNDROS. Available in 4 different strengths, such as 2.5MG, 10MG, 5MG and others, and administered through 2 routes including CAPSULE;ORAL, SOLUTION;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"76899","ingredient":"DRONABINOL","trade_name":"SYNDROS","family_id":"96a4394c2a3648bb87ce","publication_number":"US10265293B2","cleaned_patent_number":"10265293","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-06","publication_date":"2019-04-23","legal_status":"Granted"} | US10265293B2 Molecular Formulation | 23 Apr, 2019 | Granted | 06 Aug, 2028 | |
| {"application_id":"76900","ingredient":"DRONABINOL","trade_name":"SYNDROS","family_id":"96a4394c2a3648bb87ce","publication_number":"US11253472B2","cleaned_patent_number":"11253472","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-06","publication_date":"2022-02-22","legal_status":"Granted"} | US11253472B2 Molecular Formulation | 22 Feb, 2022 | Granted | 06 Aug, 2028 | |
| {"application_id":"76902","ingredient":"DRONABINOL","trade_name":"SYNDROS","family_id":"c0df54ed81e34ac1824b","publication_number":"US8222292B2","cleaned_patent_number":"8222292","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-06","publication_date":"2012-07-17","legal_status":"Granted"} | US8222292B2 Molecular Formulation | 17 Jul, 2012 | Granted | 06 Aug, 2028 | |
| {"application_id":"76898","ingredient":"DRONABINOL","trade_name":"SYNDROS","family_id":"96a4394c2a3648bb87ce","publication_number":"US9345771B2","cleaned_patent_number":"9345771","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-06","publication_date":"2016-05-24","legal_status":"Granted"} | US9345771B2 Molecular Formulation | 24 May, 2016 | Granted | 06 Aug, 2028 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.