NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as MARINUS. It is marketed under 1 brand name, including ZTALMY. Available in 1 different strength, such as 50MG/ML, and administered through 1 route including SUSPENSION;ORAL.
API availability: Loading API feasibility...
Licensing: 1 potential partnersUS Launch window: Loading launch window...
Stay ahead with worldwide patent expiry and latest updates.
FDA approval history for this ingredient
Stay ahead with worldwide patent expiry insights, exclusivity data, and latest updates.
Key expiration dates for US patents covering this ingredient
Stay ahead with worldwide patent expiry insights, market data, and research updates.
Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
|
|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"120130","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"5c832f470f584a31b49f","publication_number":"US9056116B2","cleaned_patent_number":"9056116","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-28","publication_date":"2015-06-16","legal_status":"Granted"} | US9056116B2 | 16 Jun, 2015 | Granted | 28 Nov, 2026 | |
| {"application_id":"120128","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"5c832f470f584a31b49f","publication_number":"US8618087B2","cleaned_patent_number":"8618087","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-28","publication_date":"2013-12-31","legal_status":"Granted"} | US8618087B2 | 31 Dec, 2013 | Granted | 28 Nov, 2026 | |
| {"application_id":"120129","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"5c832f470f584a31b49f","publication_number":"US9029355B2","cleaned_patent_number":"9029355","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-28","publication_date":"2015-05-12","legal_status":"Granted"} | US9029355B2 Formulation | 12 May, 2015 | Granted | 28 Nov, 2026 | |
| {"application_id":"120126","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"5c832f470f584a31b49f","publication_number":"US7858609B2","cleaned_patent_number":"7858609","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-28","publication_date":"2010-12-28","legal_status":"Granted"} | US7858609B2 Formulation | 28 Dec, 2010 | Granted | 28 Nov, 2026 | |
| {"application_id":"83304","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"5c832f470f584a31b49f","publication_number":"US8022054B2","cleaned_patent_number":"8022054","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-28","publication_date":"2011-09-20","legal_status":"Granted"} | US8022054B2 Formulation | 20 Sep, 2011 | Granted | 28 Nov, 2026 | |
| {"application_id":"120127","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"5c832f470f584a31b49f","publication_number":"US8318714B2","cleaned_patent_number":"8318714","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-28","publication_date":"2012-11-27","legal_status":"Patented case"} | US8318714B2 Formulation | 27 Nov, 2012 | Patented case | 28 Nov, 2026 | |
| {"application_id":"120124","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"5c832f470f584a31b49f","publication_number":"US8367651B2","cleaned_patent_number":"8367651","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-28","publication_date":"2013-02-05","legal_status":"Granted"} | US8367651B2 Formulation | 05 Feb, 2013 | Granted | 28 Nov, 2026 | |
| {"application_id":"110255","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"8a226f3c085546068506","publication_number":"US20220362224A1","cleaned_patent_number":"12144801","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-10","publication_date":"2022-11-17","legal_status":"Pending"} | US12144801B2 | 17 Nov, 2022 | Pending | 10 Aug, 2037 | |
| {"application_id":"36903","ingredient":"GANAXOLONE","trade_name":"ZTALMY","family_id":"8a226f3c085546068506","publication_number":"US10603308B2","cleaned_patent_number":"10603308","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-10","publication_date":"2020-03-31","legal_status":"Granted"} | US10603308B2 | 31 Mar, 2020 | Granted | 10 Aug, 2037 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Unlock access to all suppliers of Ganaxolone
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.