NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 9 pharmaceutical companies such as ABBVIE ENDOCRINE INC, ABBVIE ENDOCRINE, INVAGEN PHARMS and others. It is marketed under 6 brand names, including LUPRON DEPOT, LUPRON DEPOT-PED KIT, LUPANETA PACK and others. Available in 7 different strengths, such as 45MG, 11.25MG, 30MG and others, and administered through 6 routes including INJECTABLE;INJECTION, POWDER;INTRAMUSCULAR, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL and others.
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Licensing: 9 potential partnersUS Launch window: Loading launch window...
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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":"61768","ingredient":"LEUPROLIDE ACETATE","trade_name":"LUPRON DEPOT","family_id":"e5888f8ae7eb45f88659","publication_number":"US9617303B2","cleaned_patent_number":"9617303","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-03-22","publication_date":"2017-04-11","legal_status":"Granted"} | US9617303B2 | 11 Apr, 2017 | Granted | 22 Mar, 2028 | |
| {"application_id":"61740","ingredient":"LEUPROLIDE ACETATE","trade_name":"LUPRON DEPOT","family_id":"e5888f8ae7eb45f88659","publication_number":"US8921326B2","cleaned_patent_number":"8921326","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-05","publication_date":"2014-12-30","legal_status":"Granted"} | US8921326B2 Formulation | 30 Dec, 2014 | Granted | 05 Feb, 2031 | |
| {"application_id":"117454","ingredient":"LEUPROLIDE ACETATE","trade_name":"ELIGARD KIT","family_id":"a449adc0e7754e659a90","publication_number":"US11771841B2","cleaned_patent_number":"11771841","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-12-22","publication_date":"2023-10-03","legal_status":"Granted"} | US11771841B2 Molecular Formulation | 03 Oct, 2023 | Granted | 22 Dec, 2041 | |
| {"application_id":"123306","ingredient":"LEUPROLIDE ACETATE","trade_name":"ELIGARD KIT","family_id":"","publication_number":"US11931559B2","cleaned_patent_number":"11931559","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-12-22","publication_date":"2024-03-19","legal_status":"Granted"} | US11931559B2 Molecular | 19 Mar, 2024 | Granted | 22 Dec, 2041 |
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.