NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 11 pharmaceutical companies such as NOVARTIS, NOVARTIS PHARM, HIKMA and others. It is marketed under 4 brand names, including ZORTRESS, AFINITOR, AFINITOR DISPERZ and others. Available in 10 different strengths, such as 0.25MG, 0.75MG, 0.5MG and others, and administered through 2 routes including TABLET;ORAL, TABLET, FOR SUSPENSION;ORAL. The latest reported annual revenue is $670,542,439 in 2024.
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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":"88252","ingredient":"EVEROLIMUS","trade_name":"AFINITOR","family_id":"07a23fa6e99648c1b0fd","publication_number":"US8410131B2","cleaned_patent_number":"8410131","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-01","publication_date":"2013-04-02","legal_status":"Granted"} | US8410131B2 | 02 Apr, 2013 | Granted | 01 May, 2026 | |
| {"application_id":"89751","ingredient":"EVEROLIMUS","trade_name":"AFINITOR","family_id":"67474d838cb446f1a7c7","publication_number":"US9006224B2","cleaned_patent_number":"9006224","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-01","publication_date":"2015-04-14","legal_status":"Granted"} | US9006224B2 | 14 Apr, 2015 | Granted | 01 Jul, 2028 |
Country wise drug prices over the years
Country wise drug revenue over the years
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.