Calcifediol Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 1 pharmaceutical company such as EIRGEN. It is marketed under 1 brand name, including RAYALDEE. Available in 1 different strength, such as 0.03MG, and administered through 1 route including CAPSULE, EXTENDED RELEASE;ORAL.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"44865","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"36b0fb91946b4de79b45","publication_number":"US10213442B2","cleaned_patent_number":"10213442","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-02","publication_date":"2019-02-26","legal_status":"Granted"} US10213442B2 Formulation 26 Feb, 2019 Granted 02 Feb, 2027
{"application_id":"44864","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"36b0fb91946b4de79b45","publication_number":"US8906410B2","cleaned_patent_number":"8906410","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-02","publication_date":"2014-12-09","legal_status":"Granted"} US8906410B2 Formulation 09 Dec, 2014 Granted 02 Feb, 2027
{"application_id":"44838","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"36b0fb91946b4de79b45","publication_number":"US9943530B2","cleaned_patent_number":"9943530","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-02","publication_date":"2018-04-17","legal_status":"Granted"} US9943530B2 17 Apr, 2018 Granted 02 Feb, 2027
{"application_id":"44834","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"df42a8ad851143569d5c","publication_number":"US11154509B2","cleaned_patent_number":"11154509","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-25","publication_date":"2021-10-26","legal_status":"Granted"} US11154509B2 26 Oct, 2021 Granted 25 Apr, 2028
{"application_id":"44828","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"df42a8ad851143569d5c","publication_number":"US8207149B2","cleaned_patent_number":"8207149","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-25","publication_date":"2012-06-26","legal_status":"Granted"} US8207149B2 26 Jun, 2012 Granted 25 Apr, 2028
{"application_id":"44788","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"df42a8ad851143569d5c","publication_number":"US8778373B2","cleaned_patent_number":"8778373","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-25","publication_date":"2014-07-15","legal_status":"Granted"} US8778373B2 15 Jul, 2014 Granted 25 Apr, 2028
{"application_id":"44833","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"df42a8ad851143569d5c","publication_number":"US9925147B2","cleaned_patent_number":"9925147","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-25","publication_date":"2018-03-27","legal_status":"Granted"} US9925147B2 Formulation 27 Mar, 2018 Granted 25 Apr, 2028
{"application_id":"44830","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"df42a8ad851143569d5c","publication_number":"US9408858B2","cleaned_patent_number":"9408858","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-25","publication_date":"2016-08-09","legal_status":"Granted"} US9408858B2 09 Aug, 2016 Granted 25 Apr, 2028
{"application_id":"44871","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"","publication_number":"US9498486B2","cleaned_patent_number":"9498486","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-25","publication_date":"2016-11-22","legal_status":"Granted"} US9498486B2 22 Nov, 2016 Granted 25 Apr, 2028
{"application_id":"44829","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"df42a8ad851143569d5c","publication_number":"US8361488B2","cleaned_patent_number":"8361488","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-19","publication_date":"2013-01-29","legal_status":"Granted"} US8361488B2 Formulation 29 Jan, 2013 Granted 19 Jul, 2028
{"application_id":"44863","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"36b0fb91946b4de79b45","publication_number":"US8426391B2","cleaned_patent_number":"8426391","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-27","publication_date":"2013-04-23","legal_status":"Granted"} US8426391B2 23 Apr, 2013 Granted 27 Aug, 2028
{"application_id":"117076","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"275f48b064724e3791df","publication_number":"US11801253B2","cleaned_patent_number":"11801253","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-09-07","publication_date":"2023-10-31","legal_status":"Granted"} US11801253B2 Formulation 31 Oct, 2023 Granted 07 Sep, 2030
{"application_id":"44872","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"f920ce28fbc04a0594fb","publication_number":"US10357502B2","cleaned_patent_number":"10357502","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2019-07-23","legal_status":"Granted"} US10357502B2 Formulation 23 Jul, 2019 Granted 14 Mar, 2034
{"application_id":"44941","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"f920ce28fbc04a0594fb","publication_number":"US10300078B2","cleaned_patent_number":"10300078","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2019-05-28","legal_status":"Granted"} US10300078B2 Formulation 28 May, 2019 Granted 14 Mar, 2034
{"application_id":"44943","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"f920ce28fbc04a0594fb","publication_number":"US11253528B2","cleaned_patent_number":"11253528","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2022-02-22","legal_status":"Patented case"} US11253528B2 Formulation 22 Feb, 2022 Patented case 14 Mar, 2034
{"application_id":"44940","ingredient":"CALCIFEDIOL","trade_name":"RAYALDEE","family_id":"f920ce28fbc04a0594fb","publication_number":"US9861644B2","cleaned_patent_number":"9861644","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2018-01-09","legal_status":"Granted"} US9861644B2 Formulation 09 Jan, 2018 Granted 14 Mar, 2034

Recent Clinical Trials

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.

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