NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 30 pharmaceutical companies such as WATSON LABS INC, GLENMARK SPECLT, STRIDES PHARMA and others. It is marketed under 3 brand names, including ROSUVASTATIN CALCIUM, EZALLOR SPRINKLE, ROSZET. Available in 8 different strengths, such as EQ 40MG BASE, EQ 5MG BASE, EQ 10MG BASE and others, and administered through 2 routes including TABLET;ORAL, CAPSULE;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":"98661","ingredient":"EZETIMIBE; ROSUVASTATIN CALCIUM","trade_name":"ROSZET","family_id":"f4d350980691421fba99","publication_number":"US10376470B2","cleaned_patent_number":"10376470","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-05-01","publication_date":"2019-08-13","legal_status":"Granted"} | US10376470B2 Formulation | 13 Aug, 2019 | Granted | 01 May, 2033 | |
| {"application_id":"98670","ingredient":"EZETIMIBE; ROSUVASTATIN CALCIUM","trade_name":"ROSZET","family_id":"f4d350980691421fba99","publication_number":"US9763885B2","cleaned_patent_number":"9763885","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-05-01","publication_date":"2017-09-19","legal_status":"Granted"} | US9763885B2 Formulation | 19 Sep, 2017 | Granted | 01 May, 2033 | |
| {"application_id":"47031","ingredient":"ROSUVASTATIN CALCIUM","trade_name":"EZALLOR SPRINKLE","family_id":"b6a8708760e6465695a5","publication_number":"US10413543B2","cleaned_patent_number":"10413543","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-12","publication_date":"2019-09-17","legal_status":"Granted"} | US10413543B2 Formulation | 17 Sep, 2019 | Granted | 12 Feb, 2036 |
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.