NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 16 pharmaceutical companies such as AMNEAL, SANDOZ, FRESENIUS KABI USA and others. It is marketed under 1 brand name, including FULVESTRANT. Available in 1 different strength, such as 250MG/5ML (50MG/ML), and administered through 1 route including SOLUTION;INTRAMUSCULAR.
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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":"71468","ingredient":"FULVESTRANT","trade_name":"FULVESTRANT","family_id":"8b5f0afc7c02405fb5f8","publication_number":"US10188663B2","cleaned_patent_number":"10188663","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-14","publication_date":"2019-01-29","legal_status":"Granted"} | US10188663B2 Formulation | 29 Jan, 2019 | Granted | 14 Feb, 2034 | |
| {"application_id":"71467","ingredient":"FULVESTRANT","trade_name":"FULVESTRANT","family_id":"8b5f0afc7c02405fb5f8","publication_number":"US9833459B2","cleaned_patent_number":"9833459","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-14","publication_date":"2017-12-05","legal_status":"Granted"} | US9833459B2 Formulation | 05 Dec, 2017 | Granted | 14 Feb, 2034 | |
| {"application_id":"71466","ingredient":"FULVESTRANT","trade_name":"FULVESTRANT","family_id":"8b5f0afc7c02405fb5f8","publication_number":"US9271990B2","cleaned_patent_number":"9271990","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-17","publication_date":"2016-03-01","legal_status":"Granted"} | US9271990B2 Formulation | 01 Mar, 2016 | Granted | 17 May, 2034 |
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.