Progesterone Global Patent Coverage & Expiry Overview

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It is formulated by 18 pharmaceutical companies such as HIKMA FARMACEUTICA, TEVA PHARMS, SOFGEN PHARMS and others. It is marketed under 6 brand names, including PROGESTERONE, HYDROXYPROGESTERONE CAPROATE, MEDROXYPROGESTERONE ACETATE and others. Available in 8 different strengths, such as 50MG/ML, 200MG, 100MG and others, and administered through 4 routes including INJECTABLE;INJECTION, CAPSULE;ORAL, SOLUTION;INTRAMUSCULAR and others.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

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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":"83811","ingredient":"PROGESTERONE","trade_name":"MILPROSA","family_id":"facf5756a8a64a4db7ce","publication_number":"US10548904B2","cleaned_patent_number":"10548904","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-03","publication_date":"2020-02-04","legal_status":"Granted"} US10548904B2 04 Feb, 2020 Granted 03 Feb, 2029
{"application_id":"83854","ingredient":"PROGESTERONE","trade_name":"MILPROSA","family_id":"facf5756a8a64a4db7ce","publication_number":"US10537584B2","cleaned_patent_number":"10537584","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-03","publication_date":"2020-01-21","legal_status":"Granted"} US10537584B2 Formulation 21 Jan, 2020 Granted 03 Feb, 2029
{"application_id":"83853","ingredient":"PROGESTERONE","trade_name":"MILPROSA","family_id":"facf5756a8a64a4db7ce","publication_number":"US8580293B2","cleaned_patent_number":"8580293","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-21","publication_date":"2013-11-12","legal_status":"Granted"} US8580293B2 12 Nov, 2013 Granted 21 Jan, 2030
{"application_id":"46169","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US10675288B2","cleaned_patent_number":"10675288","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2020-06-09","legal_status":"Patented case"} US10675288B2 09 Jun, 2020 Patented case 21 Nov, 2032
{"application_id":"46171","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US10806740B2","cleaned_patent_number":"10806740","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2020-10-20","legal_status":"Granted"} US10806740B2 Formulation 20 Oct, 2020 Granted 21 Nov, 2032
{"application_id":"46174","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US11033626B2","cleaned_patent_number":"11033626","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2021-06-15","legal_status":"Patented case"} US11033626B2 Formulation 15 Jun, 2021 Patented case 21 Nov, 2032
{"application_id":"46028","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"b00f82dd606a4949bd96","publication_number":"US11103513B2","cleaned_patent_number":"11103513","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2021-08-31","legal_status":"Granted"} US11103513B2 31 Aug, 2021 Granted 21 Nov, 2032
{"application_id":"46176","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US11103516B2","cleaned_patent_number":"11103516","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2021-08-31","legal_status":"Patented case"} US11103516B2 Formulation 31 Aug, 2021 Patented case 21 Nov, 2032
{"application_id":"46177","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US11110099B2","cleaned_patent_number":"11110099","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2021-09-07","legal_status":"Granted"} US11110099B2 Formulation 07 Sep, 2021 Granted 21 Nov, 2032
{"application_id":"46180","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US11166963B2","cleaned_patent_number":"11166963","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2021-11-09","legal_status":"Patented case"} US11166963B2 Formulation 09 Nov, 2021 Patented case 21 Nov, 2032
{"application_id":"46200","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US11529360B2","cleaned_patent_number":"11529360","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2022-12-20","legal_status":"Patented case"} US11529360B2 Formulation 20 Dec, 2022 Patented case 21 Nov, 2032
{"application_id":"46198","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US11793819B2","cleaned_patent_number":"11793819","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2023-10-24","legal_status":"Patented case"} US11793819B2 24 Oct, 2023 Patented case 21 Nov, 2032
{"application_id":"46206","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US11865179B2","cleaned_patent_number":"11865179","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2024-01-09","legal_status":"Granted"} US11865179B2 Molecular Formulation 09 Jan, 2024 Granted 21 Nov, 2032
{"application_id":"46144","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US8633178B2","cleaned_patent_number":"8633178","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2014-01-21","legal_status":"Granted"} US8633178B2 Formulation 21 Jan, 2014 Granted 21 Nov, 2032
{"application_id":"46145","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US8846648B2","cleaned_patent_number":"8846648","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2014-09-30","legal_status":"Granted"} US8846648B2 30 Sep, 2014 Granted 21 Nov, 2032
{"application_id":"46032","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US8846649B2","cleaned_patent_number":"8846649","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2014-09-30","legal_status":"Granted"} US8846649B2 Formulation 30 Sep, 2014 Granted 21 Nov, 2032
{"application_id":"46146","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US8933059B2","cleaned_patent_number":"8933059","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2015-01-13","legal_status":"Granted"} US8933059B2 Formulation 13 Jan, 2015 Granted 21 Nov, 2032
{"application_id":"46147","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US8987237B2","cleaned_patent_number":"8987237","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2015-03-24","legal_status":"Patented case"} US8987237B2 Formulation 24 Mar, 2015 Patented case 21 Nov, 2032
{"application_id":"46149","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US8993548B2","cleaned_patent_number":"8993548","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2015-03-31","legal_status":"Patented case"} US8993548B2 Formulation 31 Mar, 2015 Patented case 21 Nov, 2032
{"application_id":"46150","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US8993549B2","cleaned_patent_number":"8993549","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2015-03-31","legal_status":"Granted"} US8993549B2 Formulation 31 Mar, 2015 Granted 21 Nov, 2032
{"application_id":"46151","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US9006222B2","cleaned_patent_number":"9006222","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2015-04-14","legal_status":"Granted"} US9006222B2 Formulation 14 Apr, 2015 Granted 21 Nov, 2032
{"application_id":"46153","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US9114145B2","cleaned_patent_number":"9114145","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2015-08-25","legal_status":"Patented case"} US9114145B2 25 Aug, 2015 Patented case 21 Nov, 2032
{"application_id":"46154","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US9114146B2","cleaned_patent_number":"9114146","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2015-08-25","legal_status":"Granted"} US9114146B2 Formulation 25 Aug, 2015 Granted 21 Nov, 2032
{"application_id":"46160","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US10052386B2","cleaned_patent_number":"10052386","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2018-08-21","legal_status":"Patented case"} US10052386B2 Formulation 21 Aug, 2018 Patented case 21 Nov, 2032
{"application_id":"46158","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US9301920B2","cleaned_patent_number":"9301920","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2016-04-05","legal_status":"Granted"} US9301920B2 Formulation 05 Apr, 2016 Granted 21 Nov, 2032
{"application_id":"46018","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"b00f82dd606a4949bd96","publication_number":"US10206932B2","cleaned_patent_number":"10206932","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2019-02-19","legal_status":"Granted"} US10206932B2 19 Feb, 2019 Granted 21 Nov, 2032
{"application_id":"46167","ingredient":"ESTRADIOL; PROGESTERONE","trade_name":"BIJUVA","family_id":"e304e34c9ffb4cbdb06a","publication_number":"US10639375B2","cleaned_patent_number":"10639375","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-21","publication_date":"2020-05-05","legal_status":"Granted"} US10639375B2 Formulation 05 May, 2020 Granted 21 Nov, 2032

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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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