Cyclosporine Global Patent Coverage & Expiry Overview

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It is formulated by 9 pharmaceutical companies such as ABBVIE, SUN PHARM, APOTEX and others. It is marketed under 5 brand names, including RESTASIS MULTIDOSE, CEQUA, CYCLOSPORINE and others. Available in 6 different strengths, such as 0.05%, 0.09%, 25MG and others, and administered through 3 routes including EMULSION;OPHTHALMIC, SOLUTION;OPHTHALMIC, CAPSULE;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":"56112","ingredient":"CYCLOSPORINE","trade_name":"VERKAZIA","family_id":"be33d1675a2043aaa3b7","publication_number":"US11612658B2","cleaned_patent_number":"11612658","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-27","publication_date":"2023-03-28","legal_status":"Granted"} US11612658B2 28 Mar, 2023 Granted 27 Jan, 2026
{"application_id":"56109","ingredient":"CYCLOSPORINE","trade_name":"VERKAZIA","family_id":"be33d1675a2043aaa3b7","publication_number":"US9956289B2","cleaned_patent_number":"9956289","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-27","publication_date":"2018-05-01","legal_status":"Granted"} US9956289B2 Formulation 01 May, 2018 Granted 27 Jan, 2026
{"application_id":"56067","ingredient":"CYCLOSPORINE","trade_name":"VERKAZIA","family_id":"be33d1675a2043aaa3b7","publication_number":"US9220694B2","cleaned_patent_number":"9220694","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-27","publication_date":"2015-12-29","legal_status":"Granted"} US9220694B2 Formulation 29 Dec, 2015 Granted 27 Jan, 2026
{"application_id":"56107","ingredient":"CYCLOSPORINE","trade_name":"VERKAZIA","family_id":"be33d1675a2043aaa3b7","publication_number":"US8524779B2","cleaned_patent_number":"8524779","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-27","publication_date":"2013-09-03","legal_status":"Patented case"} US8524779B2 Formulation 03 Sep, 2013 Patented case 27 Jan, 2026
{"application_id":"56105","ingredient":"CYCLOSPORINE","trade_name":"VERKAZIA","family_id":"be33d1675a2043aaa3b7","publication_number":"US7973081B2","cleaned_patent_number":"7973081","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-27","publication_date":"2011-07-05","legal_status":"Patented case"} US7973081B2 Formulation 05 Jul, 2011 Patented case 27 Jan, 2026
{"application_id":"56000","ingredient":"CYCLOSPORINE","trade_name":"VERKAZIA","family_id":"e5b3d7b54aaa449a8e7f","publication_number":"US8298568B2","cleaned_patent_number":"8298568","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-03","publication_date":"2012-10-30","legal_status":"Granted"} US8298568B2 Formulation 30 Oct, 2012 Granted 03 Nov, 2027
{"application_id":"56108","ingredient":"CYCLOSPORINE","trade_name":"VERKAZIA","family_id":"be33d1675a2043aaa3b7","publication_number":"US9132071B2","cleaned_patent_number":"9132071","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-02","publication_date":"2015-09-15","legal_status":"Granted"} US9132071B2 Formulation 15 Sep, 2015 Granted 02 Jun, 2029
{"application_id":"115907","ingredient":"CYCLOSPORINE","trade_name":"VEVYE","family_id":"74b7c9c0cfb74ef29e78","publication_number":"US8614178B2","cleaned_patent_number":"8614178","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-13","publication_date":"2013-12-24","legal_status":"Granted"} US8614178B2 Formulation 24 Dec, 2013 Granted 13 Dec, 2030
{"application_id":"55966","ingredient":"CYCLOSPORINE","trade_name":"RESTASIS MULTIDOSE","family_id":"2bdceaa668c34d609266","publication_number":"US8292129B2","cleaned_patent_number":"8292129","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-25","publication_date":"2012-10-23","legal_status":"Granted"} US8292129B2 Formulation 23 Oct, 2012 Granted 25 Feb, 2031
{"application_id":"55996","ingredient":"CYCLOSPORINE","trade_name":"RESTASIS MULTIDOSE","family_id":"e92421aa950a4ad6b7c4","publication_number":"US8561859B2","cleaned_patent_number":"8561859","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-04-16","publication_date":"2013-10-22","legal_status":"Granted"} US8561859B2 Formulation 22 Oct, 2013 Granted 16 Apr, 2032
{"application_id":"75856","ingredient":"CYCLOSPORINE","trade_name":"CEQUA","family_id":"ad21333ba7394cc595e0","publication_number":"US8980839B2","cleaned_patent_number":"8980839","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-08-23","publication_date":"2015-03-17","legal_status":"Granted"} US8980839B2 Formulation 17 Mar, 2015 Granted 23 Aug, 2033
{"application_id":"75863","ingredient":"CYCLOSPORINE","trade_name":"CEQUA","family_id":"ad21333ba7394cc595e0","publication_number":"US9937225B2","cleaned_patent_number":"9937225","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-08-23","publication_date":"2018-04-10","legal_status":"Granted"} US9937225B2 Formulation 10 Apr, 2018 Granted 23 Aug, 2033
{"application_id":"75864","ingredient":"CYCLOSPORINE","trade_name":"CEQUA","family_id":"ad21333ba7394cc595e0","publication_number":"US10441630B2","cleaned_patent_number":"10441630","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-08-23","publication_date":"2019-10-15","legal_status":"Granted"} US10441630B2 Formulation 15 Oct, 2019 Granted 23 Aug, 2033
{"application_id":"55970","ingredient":"CYCLOSPORINE","trade_name":"RESTASIS MULTIDOSE","family_id":"93f83595296942899a74","publication_number":"US9676525B2","cleaned_patent_number":"9676525","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-07","publication_date":"2017-06-13","legal_status":"Granted"} US9676525B2 Formulation 13 Jun, 2017 Granted 07 Feb, 2034
{"application_id":"55944","ingredient":"CYCLOSPORINE","trade_name":"RESTASIS MULTIDOSE","family_id":"7d3128cddb424170a0a4","publication_number":"US9669974B2","cleaned_patent_number":"9669974","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-11","publication_date":"2017-06-06","legal_status":"Granted"} US9669974B2 Formulation 06 Jun, 2017 Granted 11 May, 2034
{"application_id":"123308","ingredient":"CYCLOSPORINE","trade_name":"CEQUA","family_id":"","publication_number":"US11951153B2","cleaned_patent_number":"11951153","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-02-28","publication_date":"2024-04-09","legal_status":"Granted"} US11951153B2 09 Apr, 2024 Granted 28 Feb, 2037
{"application_id":"75869","ingredient":"CYCLOSPORINE","trade_name":"CEQUA","family_id":"a6acb3a72022457bbf10","publication_number":"US10918694B2","cleaned_patent_number":"10918694","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-02-28","publication_date":"2021-02-16","legal_status":"Granted"} US10918694B2 Formulation 16 Feb, 2021 Granted 28 Feb, 2037
{"application_id":"115932","ingredient":"CYCLOSPORINE","trade_name":"VEVYE","family_id":"4dfadc3b6c734860b7b0","publication_number":"US10813976B2","cleaned_patent_number":"10813976","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-09-22","publication_date":"2020-10-27","legal_status":"Granted"} US10813976B2 Formulation 27 Oct, 2020 Granted 22 Sep, 2037
{"application_id":"115945","ingredient":"CYCLOSPORINE","trade_name":"VEVYE","family_id":"9f3d30ecfc8a426e83b9","publication_number":"US11154513B2","cleaned_patent_number":"11154513","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-11-20","publication_date":"2021-10-26","legal_status":"Granted"} US11154513B2 Formulation 26 Oct, 2021 Granted 20 Nov, 2038
{"application_id":"115975","ingredient":"CYCLOSPORINE","trade_name":"VEVYE","family_id":"da7a66452a3a42a29b82","publication_number":"US11413323B2","cleaned_patent_number":"11413323","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-10-11","publication_date":"2022-08-16","legal_status":"Granted"} US11413323B2 16 Aug, 2022 Granted 11 Oct, 2039
{"application_id":"115984","ingredient":"CYCLOSPORINE","trade_name":"VEVYE","family_id":"da7a66452a3a42a29b82","publication_number":"US2022226427A1","cleaned_patent_number":"12059449","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-04-01","publication_date":"2022-07-21","legal_status":"Pending"} US12059449B2 Formulation 21 Jul, 2022 Pending 01 Apr, 2042

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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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