NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 27 pharmaceutical companies such as CHARTWELL RX, SUN PHARM, ACTAVIS ELIZABETH and others. It is marketed under 2 brand names, including RANOLAZINE, ASPRUZYO SPRINKLE. Available in 2 different strengths, such as 1GM, 500MG, and administered through 2 routes including TABLET, EXTENDED RELEASE;ORAL, GRANULES, EXTENDED RELEASE;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":"104840","ingredient":"RANOLAZINE","trade_name":"ASPRUZYO SPRINKLE","family_id":"26cf5df9fa2c4fd48505","publication_number":"US10898444B2","cleaned_patent_number":"10898444","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-24","publication_date":"2021-01-26","legal_status":"Granted"} | US10898444B2 Formulation | 26 Jan, 2021 | Granted | 24 Jan, 2038 | |
| {"application_id":"104842","ingredient":"RANOLAZINE","trade_name":"ASPRUZYO SPRINKLE","family_id":"26cf5df9fa2c4fd48505","publication_number":"US11510878B2","cleaned_patent_number":"11510878","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-24","publication_date":"2022-11-29","legal_status":"Granted"} | US11510878B2 Formulation | 29 Nov, 2022 | Granted | 24 Jan, 2038 | |
| {"application_id":"139375","ingredient":"RANOLAZINE","trade_name":"ASPRUZYO SPRINKLE","family_id":"","publication_number":"US12161761B2","cleaned_patent_number":"12161761","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-24","publication_date":"2024-12-10","legal_status":"Patented Case"} | US12161761B2 Formulation | 10 Dec, 2024 | Patented Case | 24 Jan, 2038 |
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.