Tretinoin Global Patent Coverage & Expiry Overview

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It is formulated by 25 pharmaceutical companies such as ALLERGAN, ALMIRALL, UPSHER SMITH LABS and others. It is marketed under 13 brand names, including TRETINOIN, VELTIN, MYORISAN and others. Available in 22 different strengths, such as 0.0375%, 1.2%;0.025%, 10MG and others, and administered through 4 routes including CREAM;TOPICAL, GEL;TOPICAL, CAPSULE;ORAL and others.

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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":"55313","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"5d007a5c412a4bc680d0","publication_number":"US8617580B2","cleaned_patent_number":"8617580","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-03","publication_date":"2013-12-31","legal_status":"Granted"} US8617580B2 Formulation 31 Dec, 2013 Granted 03 Feb, 2028
{"application_id":"139373","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"","publication_number":"US12156946B2","cleaned_patent_number":"12156946","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-03","publication_date":"2024-12-03","legal_status":"Granted"} US12156946B2 Formulation 03 Dec, 2024 Granted 03 Feb, 2028
{"application_id":"54689","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"09f0af1bbf23403187bc","publication_number":"US9868103B2","cleaned_patent_number":"9868103","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-08","publication_date":"2018-01-16","legal_status":"Granted"} US9868103B2 Formulation 16 Jan, 2018 Granted 08 Aug, 2028
{"application_id":"55308","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"de51050de26e48cf8be1","publication_number":"US20210290985A1","cleaned_patent_number":"12070629","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-30","publication_date":"2021-09-23","legal_status":"Pending"} US12070629B2 Formulation 23 Sep, 2021 Pending 30 Dec, 2030
{"application_id":"55306","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"de51050de26e48cf8be1","publication_number":"US11071878B2","cleaned_patent_number":"11071878","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-30","publication_date":"2021-07-27","legal_status":"Granted"} US11071878B2 Formulation 27 Jul, 2021 Granted 30 Dec, 2030
{"application_id":"55293","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"de51050de26e48cf8be1","publication_number":"US10653899B2","cleaned_patent_number":"10653899","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-30","publication_date":"2020-05-19","legal_status":"Granted"} US10653899B2 Formulation 19 May, 2020 Granted 30 Dec, 2030
{"application_id":"130692","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"","publication_number":"US12053546B2","cleaned_patent_number":"12053546","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-29","publication_date":"2024-08-06","legal_status":"Granted"} US12053546B2 Formulation 06 Aug, 2024 Granted 29 Jun, 2032
{"application_id":"45404","ingredient":"ISOTRETINOIN","trade_name":"ABSORICA LD","family_id":"b98a7da940e54970b957","publication_number":"US9750711B2","cleaned_patent_number":"9750711","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-29","publication_date":"2017-09-05","legal_status":"Granted"} US9750711B2 Formulation 05 Sep, 2017 Granted 29 May, 2035
{"application_id":"45417","ingredient":"ISOTRETINOIN","trade_name":"ABSORICA LD","family_id":"f598b295a6a9471daf9e","publication_number":"US9700535B2","cleaned_patent_number":"9700535","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-08-04","publication_date":"2017-07-11","legal_status":"Granted"} US9700535B2 Formulation 11 Jul, 2017 Granted 04 Aug, 2035
{"application_id":"55282","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"030daabb1d6e4c5e9a0a","publication_number":"US10420743B2","cleaned_patent_number":"10420743","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-07-12","publication_date":"2019-09-24","legal_status":"Granted"} US10420743B2 24 Sep, 2019 Granted 12 Jul, 2038
{"application_id":"63433","ingredient":"TRETINOIN","trade_name":"ALTRENO","family_id":"6a83c2ebc21e4b309ac3","publication_number":"US11324710B2","cleaned_patent_number":"11324710","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-22","publication_date":"2022-05-10","legal_status":"Granted"} US11324710B2 10 May, 2022 Granted 22 Aug, 2038
{"application_id":"63428","ingredient":"TRETINOIN","trade_name":"ALTRENO","family_id":"6a83c2ebc21e4b309ac3","publication_number":"US10653656B2","cleaned_patent_number":"10653656","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-22","publication_date":"2020-05-19","legal_status":"Granted"} US10653656B2 Formulation 19 May, 2020 Granted 22 Aug, 2038
{"application_id":"114972","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"8724b062c3ff4800864f","publication_number":"US2023248687A1","cleaned_patent_number":"12295935","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-12-27","publication_date":"2025-05-13","legal_status":"Patented case"} US12295935B2 13 May, 2025 Patented case 27 Dec, 2040
{"application_id":"164409","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"","publication_number":"US12257348B2","cleaned_patent_number":"12257348","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-05-23","publication_date":"2025-03-25","legal_status":"Granted"} US12257348B2 Formulation 25 Mar, 2025 Granted 23 May, 2041
{"application_id":"138445","ingredient":"BENZOYL PEROXIDE; TRETINOIN","trade_name":"TWYNEO","family_id":"","publication_number":"","cleaned_patent_number":"12133919","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-05-23","publication_date":"2024-11-05","legal_status":"Patented Case"} US12133919B2 Formulation 05 Nov, 2024 Patented Case 23 May, 2041

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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API Suppliers/Manufacturer (Branded/Generic companies)

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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