Benzoyl Peroxide; Clindamycin Phosphate Global Patent Coverage & Expiry Overview

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It is formulated by 8 pharmaceutical companies such as PADAGIS ISRAEL, BAUSCH, ACTAVIS LABS UT INC and others. It is marketed under 3 brand names, including CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, ONEXTON, CABTREO. Available in 5 different strengths, such as 5%;1.2%, 3.75%;EQ 1.2% BASE, 2.5%;EQ 1.2% BASE and others, and administered through 1 route including GEL;TOPICAL.

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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":"59262","ingredient":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"ONEXTON","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US10137142B2","cleaned_patent_number":"10137142","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-03","publication_date":"2018-11-27","legal_status":"Granted"} US10137142B2 Formulation 27 Nov, 2018 Granted 03 Jun, 2029
{"application_id":"59263","ingredient":"ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"ACANYA","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US10220049B2","cleaned_patent_number":"10220049","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-03","publication_date":"2019-03-05","legal_status":"Granted"} US10220049B2 Formulation 05 Mar, 2019 Granted 03 Jun, 2029
{"application_id":"59264","ingredient":"ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"ACANYA","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US10624918B2","cleaned_patent_number":"10624918","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-03","publication_date":"2020-04-21","legal_status":"Granted"} US10624918B2 21 Apr, 2020 Granted 03 Jun, 2029
{"application_id":"59256","ingredient":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"ACANYA","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US8663699B2","cleaned_patent_number":"8663699","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-03","publication_date":"2014-03-04","legal_status":"Granted"} US8663699B2 04 Mar, 2014 Granted 03 Jun, 2029
{"application_id":"59257","ingredient":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"ACANYA","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US8895070B2","cleaned_patent_number":"8895070","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-03","publication_date":"2014-11-25","legal_status":"Granted"} US8895070B2 25 Nov, 2014 Granted 03 Jun, 2029
{"application_id":"59258","ingredient":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"ACANYA","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US9078870B2","cleaned_patent_number":"9078870","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-03","publication_date":"2015-07-14","legal_status":"Granted"} US9078870B2 Formulation 14 Jul, 2015 Granted 03 Jun, 2029
{"application_id":"59259","ingredient":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"ONEXTON","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US9504704B2","cleaned_patent_number":"9504704","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-03","publication_date":"2016-11-29","legal_status":"Granted"} US9504704B2 Formulation 29 Nov, 2016 Granted 03 Jun, 2029
{"application_id":"59260","ingredient":"ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"CABTREO","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US9561208B2","cleaned_patent_number":"9561208","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-03","publication_date":"2017-02-07","legal_status":"Granted"} US9561208B2 Formulation 07 Feb, 2017 Granted 03 Jun, 2029
{"application_id":"59241","ingredient":"ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"ACANYA","family_id":"62cb2cf4a5b3443f9c5d","publication_number":"US8288434B2","cleaned_patent_number":"8288434","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-05","publication_date":"2012-10-16","legal_status":"Granted"} US8288434B2 Formulation 16 Oct, 2012 Granted 05 Aug, 2029
{"application_id":"117269","ingredient":"ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"CABTREO","family_id":"d5b7f1bcdb3c49ca8fe4","publication_number":"US2022370315A1","cleaned_patent_number":"12128059","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-07-31","publication_date":"2024-10-29","legal_status":"Granted"} US12128059B2 Formulation 29 Oct, 2024 Granted 31 Jul, 2040
{"application_id":"138479","ingredient":"ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"CABTREO","family_id":"d5b7f1bcdb3c49ca8fe4","publication_number":"","cleaned_patent_number":"12133859","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-07-31","publication_date":"2024-11-05","legal_status":"Patented case"} US12133859B2 Formulation 05 Nov, 2024 Patented case 31 Jul, 2040
{"application_id":"138478","ingredient":"ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"CABTREO","family_id":"d5b7f1bcdb3c49ca8fe4","publication_number":"","cleaned_patent_number":"12138278","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-07-31","publication_date":"2024-11-12","legal_status":"Patented case"} US12138278B2 Formulation 12 Nov, 2024 Patented case 31 Jul, 2040
{"application_id":"117261","ingredient":"ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","trade_name":"CABTREO","family_id":"d5b7f1bcdb3c49ca8fe4","publication_number":"US11389467B2","cleaned_patent_number":"11389467","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-12-28","publication_date":"2022-07-19","legal_status":"Granted"} US11389467B2 Formulation 19 Jul, 2022 Granted 28 Dec, 2040

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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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