NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 37 pharmaceutical companies such as SUN PHARM INDS LTD, CHARTWELL RX, TEVA PHARMS and others. It is marketed under 5 brand names, including ATORVASTATIN CALCIUM, LIPTRUZET, AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM and others. Available in 20 different strengths, such as EQ 10MG BASE, EQ 40MG BASE, EQ 80MG BASE and others, and administered through 2 routes including TABLET;ORAL, SUSPENSION;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":"111321","ingredient":"ATORVASTATIN CALCIUM","trade_name":"ATORVALIQ","family_id":"0963bd776cb3440ca5b2","publication_number":"US11369567B2","cleaned_patent_number":"11369567","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2022-06-28","legal_status":"Granted"} | US11369567B2 Formulation | 28 Jun, 2022 | Granted | 07 Jun, 2037 | |
| {"application_id":"116349","ingredient":"ATORVASTATIN CALCIUM","trade_name":"ATORVALIQ","family_id":"0963bd776cb3440ca5b2","publication_number":"US11654106B2","cleaned_patent_number":"11654106","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2023-05-23","legal_status":"Granted"} | US11654106B2 Formulation | 23 May, 2023 | Granted | 07 Jun, 2037 | |
| {"application_id":"116351","ingredient":"ATORVASTATIN CALCIUM","trade_name":"ATORVALIQ","family_id":"0963bd776cb3440ca5b2","publication_number":"US11925704B2","cleaned_patent_number":"11925704","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2024-03-12","legal_status":"Granted"} | US11925704B2 Formulation | 12 Mar, 2024 | Granted | 07 Jun, 2037 | |
| {"application_id":"139403","ingredient":"ATORVASTATIN CALCIUM","trade_name":"ATORVALIQ","family_id":"","publication_number":"US12168069B2","cleaned_patent_number":"12168069","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2024-12-17","legal_status":"Granted"} | US12168069B2 Formulation | 17 Dec, 2024 | Granted | 07 Jun, 2037 |
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.