NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 14 pharmaceutical companies such as CIPLA, AUROBINDO PHARMA LTD, STRIDES PHARMA and others. It is marketed under 1 brand name, including CINACALCET HYDROCHLORIDE. Available in 6 different strengths, such as EQ 90MG BASE, EQ 30MG BASE, EQ 60MG BASE and others, and administered through 1 route including 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":"3761","ingredient":"CINACALCET HYDROCHLORIDE","trade_name":"SENSIPAR","family_id":"833a638310ca429eb273","publication_number":"US7829595B2","cleaned_patent_number":"7829595","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-09-22","publication_date":"2010-11-09","legal_status":"Patented case"} | US7829595B2 Formulation | 09 Nov, 2010 | Patented case | 22 Sep, 2026 | |
| {"application_id":"3755","ingredient":"CINACALCET HYDROCHLORIDE","trade_name":"SENSIPAR","family_id":"833a638310ca429eb273","publication_number":"US9375405B2","cleaned_patent_number":"9375405","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-09-22","publication_date":"2016-06-28","legal_status":"Patented case"} | US9375405B2 Formulation | 28 Jun, 2016 | Patented case | 22 Sep, 2026 |
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.