Roflumilast Global Patent Coverage & Expiry Overview

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It is formulated by 13 pharmaceutical companies such as ASTRAZENECA, NORVIUM BIOSCIENCE, TORRENT and others. It is marketed under 3 brand names, including DALIRESP, ROFLUMILAST, ZORYVE. Available in 4 different strengths, such as 500MCG, 250MCG, 0.3% and others, and administered through 3 routes including TABLET;ORAL, CREAM;TOPICAL, FOAM;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":"105501","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US9907788B1","cleaned_patent_number":"9907788","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2018-03-06","legal_status":"Patented case"} US9907788B2 06 Mar, 2018 Patented case 07 Jun, 2037
{"application_id":"105515","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US9884050B1","cleaned_patent_number":"9884050","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2018-02-06","legal_status":"Granted"} US9884050B2 Formulation 06 Feb, 2018 Granted 07 Jun, 2037
{"application_id":"105519","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US10940142B2","cleaned_patent_number":"10940142","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2021-03-09","legal_status":"Patented case"} US10940142B2 Formulation 09 Mar, 2021 Patented case 07 Jun, 2037
{"application_id":"105522","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US11793796B2","cleaned_patent_number":"11793796","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2023-10-24","legal_status":"Granted"} US11793796B2 Formulation 24 Oct, 2023 Granted 07 Jun, 2037
{"application_id":"117229","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US11819496B2","cleaned_patent_number":"11819496","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2023-11-21","legal_status":"Granted"} US11819496B2 21 Nov, 2023 Granted 07 Jun, 2037
{"application_id":"124053","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US11992480B2","cleaned_patent_number":"11992480","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2024-05-28","legal_status":"Granted"} US11992480B2 28 May, 2024 Granted 07 Jun, 2037
{"application_id":"105523","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US12005051B2","cleaned_patent_number":"12005051","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2024-06-11","legal_status":"Granted"} US12005051B2 11 Jun, 2024 Granted 07 Jun, 2037
{"application_id":"119586","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US12005052B2","cleaned_patent_number":"12005052","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2024-06-11","legal_status":"Granted"} US12005052B2 Formulation 11 Jun, 2024 Granted 07 Jun, 2037
{"application_id":"124054","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US12011437B2","cleaned_patent_number":"12011437","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2024-06-18","legal_status":"Patented case"} US12011437B2 Formulation 18 Jun, 2024 Patented case 07 Jun, 2037
{"application_id":"119588","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US12016848B2","cleaned_patent_number":"12016848","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2024-06-25","legal_status":"Granted"} US12016848B2 Formulation 25 Jun, 2024 Granted 07 Jun, 2037
{"application_id":"130693","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US12042487B2","cleaned_patent_number":"12042487","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2024-07-23","legal_status":"Granted"} US12042487B2 Formulation 23 Jul, 2024 Granted 07 Jun, 2037
{"application_id":"164412","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US12220409B2","cleaned_patent_number":"12220409","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2025-02-11","legal_status":"Granted"} US12220409B2 Formulation 11 Feb, 2025 Granted 07 Jun, 2037
{"application_id":"164413","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US12257242B2","cleaned_patent_number":"12257242","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2025-03-25","legal_status":"Granted"} US12257242B2 Formulation 25 Mar, 2025 Granted 07 Jun, 2037
{"application_id":"181129","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US12310956B2","cleaned_patent_number":"12310956","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-07","publication_date":"2025-05-27","legal_status":"Granted"} US12310956B2 27 May, 2025 Granted 07 Jun, 2037
{"application_id":"105520","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"29d4f6e0b5ce49d78f80","publication_number":"US11129818B2","cleaned_patent_number":"11129818","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-25","publication_date":"2021-09-28","legal_status":"Granted"} US11129818B2 28 Sep, 2021 Granted 25 Aug, 2037
{"application_id":"119570","ingredient":"ROFLUMILAST","trade_name":"ZORYVE","family_id":"5da841fee6124195a071","publication_number":"US11707454B2","cleaned_patent_number":"11707454","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-12-03","publication_date":"2023-07-25","legal_status":"Granted"} US11707454B2 25 Jul, 2023 Granted 03 Dec, 2041

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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