Drospirenone Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 17 pharmaceutical companies such as DR REDDYS LABS SA, BAYER HLTHCARE, XIROMED and others. It is marketed under 18 brand names, including DROSPIRENONE AND ETHINYL ESTRADIOL, BEYAZ, SAFYRAL and others. Available in 8 different strengths, such as 3MG;0.03MG, 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG, 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG and others, and administered through 3 routes including TABLET;ORAL-28, TABLET;ORAL, TABLET, CHEWABLE;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":"96947","ingredient":"DROSPIRENONE; ESTETROL","trade_name":"NEXTSTELLIS","family_id":"4a84e186dbd34dbc8458","publication_number":"US7732430B2","cleaned_patent_number":"7732430","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-15","publication_date":"2010-06-08","legal_status":"Granted"} US7732430B2 Formulation 08 Jun, 2010 Granted 15 Jan, 2028
{"application_id":"90994","ingredient":"DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM","trade_name":"BEYAZ","family_id":"b36e30a7b4d549e89a57","publication_number":"US8617597B2","cleaned_patent_number":"8617597","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-08","publication_date":"2013-12-31","legal_status":"Granted"} US8617597B2 Formulation 31 Dec, 2013 Granted 08 Feb, 2030
{"application_id":"90995","ingredient":"DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM","trade_name":"BEYAZ","family_id":"b36e30a7b4d549e89a57","publication_number":"US11617751B2","cleaned_patent_number":"11617751","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-17","publication_date":"2023-04-04","legal_status":"Granted"} US11617751B2 Formulation 04 Apr, 2023 Granted 17 Jul, 2030
{"application_id":"83943","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US10987364B2","cleaned_patent_number":"10987364","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2021-04-27","legal_status":"Patented case"} US10987364B2 Formulation 27 Apr, 2021 Patented case 28 Jun, 2031
{"application_id":"83930","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11123299B2","cleaned_patent_number":"11123299","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2021-09-21","legal_status":"Granted"} US11123299B2 Formulation 21 Sep, 2021 Granted 28 Jun, 2031
{"application_id":"83931","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11291632B2","cleaned_patent_number":"11291632","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2022-04-05","legal_status":"Granted"} US11291632B2 Formulation 05 Apr, 2022 Granted 28 Jun, 2031
{"application_id":"83872","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11291633B2","cleaned_patent_number":"11291633","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2022-04-05","legal_status":"Patented case"} US11291633B2 Formulation 05 Apr, 2022 Patented case 28 Jun, 2031
{"application_id":"83942","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11351122B2","cleaned_patent_number":"11351122","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2022-06-07","legal_status":"Patented case"} US11351122B2 Formulation 07 Jun, 2022 Patented case 28 Jun, 2031
{"application_id":"105759","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11413249B2","cleaned_patent_number":"11413249","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2022-08-16","legal_status":"Granted"} US11413249B2 16 Aug, 2022 Granted 28 Jun, 2031
{"application_id":"83936","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11439598B2","cleaned_patent_number":"11439598","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2022-09-13","legal_status":"Granted"} US11439598B2 Formulation 13 Sep, 2022 Granted 28 Jun, 2031
{"application_id":"108758","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11478487B2","cleaned_patent_number":"11478487","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2022-10-25","legal_status":"Patented case"} US11478487B2 Formulation 25 Oct, 2022 Patented case 28 Jun, 2031
{"application_id":"109907","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11504334B2","cleaned_patent_number":"11504334","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2022-11-22","legal_status":"Granted"} US11504334B2 Formulation 22 Nov, 2022 Granted 28 Jun, 2031
{"application_id":"123311","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US11951213B2","cleaned_patent_number":"11951213","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2024-04-09","legal_status":"Granted"} US11951213B2 09 Apr, 2024 Granted 28 Jun, 2031
{"application_id":"83925","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US9603860B2","cleaned_patent_number":"9603860","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2017-03-28","legal_status":"Granted"} US9603860B2 28 Mar, 2017 Granted 28 Jun, 2031
{"application_id":"83927","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US10603281B2","cleaned_patent_number":"10603281","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2020-03-31","legal_status":"Patented case"} US10603281B2 31 Mar, 2020 Patented case 28 Jun, 2031
{"application_id":"83928","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US10849857B2","cleaned_patent_number":"10849857","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2020-12-01","legal_status":"Granted"} US10849857B2 Formulation 01 Dec, 2020 Granted 28 Jun, 2031
{"application_id":"130723","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US12090231B2","cleaned_patent_number":"12090231","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2024-09-17","legal_status":"Granted"} US12090231B2 17 Sep, 2024 Granted 28 Jun, 2031
{"application_id":"180890","ingredient":"DROSPIRENONE","trade_name":"SLYND","family_id":"5abf1e5af69d4777a067","publication_number":"US12280151B2","cleaned_patent_number":"12280151","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2025-04-22","legal_status":"Granted"} US12280151B2 Formulation 22 Apr, 2025 Granted 28 Jun, 2031
{"application_id":"83926","ingredient":"DROSPIRENONE","trade_name":"DROSPIRENONE","family_id":"5abf1e5af69d4777a067","publication_number":"US10179140B2","cleaned_patent_number":"10179140","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-28","publication_date":"2019-01-15","legal_status":"Granted"} US10179140B2 15 Jan, 2019 Granted 28 Jun, 2031
{"application_id":"89876","ingredient":"DROSPIRENONE; ESTRADIOL","trade_name":"ANGELIQ","family_id":"c773cf547b4e40c197ad","publication_number":"US8906890B2","cleaned_patent_number":"8906890","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-10-22","publication_date":"2014-12-09","legal_status":"Granted"} US8906890B2 Formulation 09 Dec, 2014 Granted 22 Oct, 2031
{"application_id":"123318","ingredient":"DROSPIRENONE; ESTETROL","trade_name":"NEXTSTELLIS","family_id":"b81235a81146437c88bf","publication_number":"US11957694B2","cleaned_patent_number":"11957694","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-06-17","publication_date":"2024-04-16","legal_status":"Granted"} US11957694B2 Formulation 16 Apr, 2024 Granted 17 Jun, 2036
{"application_id":"118192","ingredient":"DROSPIRENONE; ESTETROL","trade_name":"NEXTSTELLIS","family_id":"67936d867d30499e8472","publication_number":"US11964055B2","cleaned_patent_number":"11964055","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-06-17","publication_date":"2024-04-23","legal_status":"Granted"} US11964055B2 Formulation 23 Apr, 2024 Granted 17 Jun, 2036
{"application_id":"118132","ingredient":"DROSPIRENONE; ESTETROL","trade_name":"NEXTSTELLIS","family_id":"67936d867d30499e8472","publication_number":"US11793760B2","cleaned_patent_number":"11793760","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-06-17","publication_date":"2023-10-24","legal_status":"Granted"} US11793760B2 Formulation 24 Oct, 2023 Granted 17 Jun, 2036
{"application_id":"164482","ingredient":"DROSPIRENONE; ESTETROL","trade_name":"NEXTSTELLIS","family_id":"","publication_number":"US12233074B2","cleaned_patent_number":"12233074","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-02-09","publication_date":"2025-02-25","legal_status":"Granted"} US12233074B2 Formulation 25 Feb, 2025 Granted 09 Feb, 2043

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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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