NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 12 pharmaceutical companies such as APIL, SUN PHARM, APOTEX and others. It is marketed under 2 brand names, including ATELVIA, RISEDRONATE SODIUM. Available in 5 different strengths, such as 35MG, 150MG, 75MG and others, and administered through 2 routes including TABLET, DELAYED RELEASE;ORAL, TABLET;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":"84162","ingredient":"RISEDRONATE SODIUM","trade_name":"ATELVIA","family_id":"bd393b30e20d4e35bdea","publication_number":"US8246989B2","cleaned_patent_number":"8246989","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-16","publication_date":"2012-08-21","legal_status":"Granted"} | US8246989B2 Formulation | 21 Aug, 2012 | Granted | 16 Jan, 2026 | |
| {"application_id":"84161","ingredient":"RISEDRONATE SODIUM","trade_name":"ATELVIA","family_id":"bd393b30e20d4e35bdea","publication_number":"US7645459B2","cleaned_patent_number":"7645459","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-09","publication_date":"2010-01-12","legal_status":"Granted"} | US7645459B2 Formulation | 12 Jan, 2010 | Granted | 09 Jan, 2028 | |
| {"application_id":"84095","ingredient":"RISEDRONATE SODIUM","trade_name":"ATELVIA","family_id":"bd393b30e20d4e35bdea","publication_number":"US7645460B2","cleaned_patent_number":"7645460","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-09","publication_date":"2010-01-12","legal_status":"Granted"} | US7645460B2 Formulation | 12 Jan, 2010 | Granted | 09 Jan, 2028 |
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.