NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as KAI PHARMS INC. It is marketed under 1 brand name, including PARSABIV. Available in 3 different strengths, such as 2.5MG/0.5ML (2.5MG/0.5ML), 5MG/ML (5MG/ML), 10MG/2ML (5MG/ML), and administered through 1 route including SOLUTION;INTRAVENOUS.
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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":"74643","ingredient":"ETELCALCETIDE","trade_name":"PARSABIV","family_id":"c5044ce435da438f9127","publication_number":"US9278995B2","cleaned_patent_number":"9278995","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-29","publication_date":"2016-03-08","legal_status":"Granted"} | US9278995B2 Molecular | 08 Mar, 2016 | Granted | 29 Jul, 2030 | |
| {"application_id":"74645","ingredient":"ETELCALCETIDE","trade_name":"PARSABIV","family_id":"c5044ce435da438f9127","publication_number":"US9701712B2","cleaned_patent_number":"9701712","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-29","publication_date":"2017-07-11","legal_status":"Granted"} | US9701712B2 Molecular Formulation | 11 Jul, 2017 | Granted | 29 Jul, 2030 | |
| {"application_id":"74642","ingredient":"ETELCALCETIDE","trade_name":"PARSABIV","family_id":"c5044ce435da438f9127","publication_number":"US8377880B2","cleaned_patent_number":"8377880","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-29","publication_date":"2013-02-19","legal_status":"Granted"} | US8377880B2 Molecular Formulation | 19 Feb, 2013 | Granted | 29 Jul, 2030 | |
| {"application_id":"74597","ingredient":"ETELCALCETIDE","trade_name":"PARSABIV","family_id":"c5044ce435da438f9127","publication_number":"US8999932B2","cleaned_patent_number":"8999932","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-07","publication_date":"2015-04-07","legal_status":"Granted"} | US8999932B2 Molecular Formulation | 07 Apr, 2015 | Granted | 07 Feb, 2031 | |
| {"application_id":"74656","ingredient":"ETELCALCETIDE","trade_name":"PARSABIV","family_id":"f4b9178f0e1846ddae85","publication_number":"US9820938B2","cleaned_patent_number":"9820938","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-27","publication_date":"2017-11-21","legal_status":"Granted"} | US9820938B2 Formulation | 21 Nov, 2017 | Granted | 27 Jun, 2034 | |
| {"application_id":"74698","ingredient":"ETELCALCETIDE","trade_name":"PARSABIV","family_id":"f4b9178f0e1846ddae85","publication_number":"US11162500B2","cleaned_patent_number":"11162500","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-27","publication_date":"2021-11-02","legal_status":"Granted"} | US11162500B2 Formulation | 02 Nov, 2021 | Granted | 27 Jun, 2034 | |
| {"application_id":"74699","ingredient":"ETELCALCETIDE","trade_name":"PARSABIV","family_id":"f4b9178f0e1846ddae85","publication_number":"US11959486B2","cleaned_patent_number":"11959486","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-27","publication_date":"2024-04-16","legal_status":"Granted"} | US11959486B2 Formulation | 16 Apr, 2024 | Granted | 27 Jun, 2034 | |
| {"application_id":"74697","ingredient":"ETELCALCETIDE","trade_name":"PARSABIV","family_id":"f4b9178f0e1846ddae85","publication_number":"US10344765B2","cleaned_patent_number":"10344765","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-27","publication_date":"2019-07-09","legal_status":"Patented case"} | US10344765B2 Formulation | 09 Jul, 2019 | Patented case | 27 Jun, 2034 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.