Diclofenac Sodium Global Patent Coverage & Expiry Overview

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It is formulated by 34 pharmaceutical companies such as UNIQUE, ACTAVIS LABS FL INC, SANDOZ and others. It is marketed under 4 brand names, including DICLOFENAC SODIUM, DICLOFENAC SODIUM AND MISOPROSTOL, PENNSAID and others. Available in 12 different strengths, such as 25MG, 50MG, 50MG;0.2MG and others, and administered through 6 routes including TABLET, DELAYED RELEASE;ORAL, GEL;TOPICAL, SOLUTION;TOPICAL 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":"73508","ingredient":"DICLOFENAC SODIUM","trade_name":"DYLOJECT","family_id":"7d1b12cad9db45ecb7eb","publication_number":"US8946292B2","cleaned_patent_number":"8946292","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-22","publication_date":"2015-02-03","legal_status":"Patented case"} US8946292B2 03 Feb, 2015 Patented case 22 Mar, 2027
{"application_id":"80623","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US9539335B2","cleaned_patent_number":"9539335","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2017-01-10","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9539335B2 10 Jan, 2017 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 17 Oct, 2027
{"application_id":"80617","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US9066913B2","cleaned_patent_number":"9066913","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2015-06-30","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9066913B2 Formulation 30 Jun, 2015 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 17 Oct, 2027
{"application_id":"80618","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US9101591B2","cleaned_patent_number":"9101591","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2015-08-11","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9101591B2 Formulation 11 Aug, 2015 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 17 Oct, 2027
{"application_id":"80588","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"f746902db5954ef7bb2e","publication_number":"US9132110B2","cleaned_patent_number":"9132110","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2015-09-15","legal_status":"Patent Expired Due to NonPayment of Maintenance Fees Under 37 CFR 1.362"} US9132110B2 15 Sep, 2015 Patent Expired Due to NonPayment of Maintenance Fees Under 37 CFR 1.362 17 Oct, 2027
{"application_id":"80619","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US9168304B2","cleaned_patent_number":"9168304","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2015-10-27","legal_status":"Granted"} US9168304B2 Formulation 27 Oct, 2015 Granted 17 Oct, 2027
{"application_id":"80599","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US9168305B2","cleaned_patent_number":"9168305","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2015-10-27","legal_status":"Patented case"} US9168305B2 27 Oct, 2015 Patented case 17 Oct, 2027
{"application_id":"80620","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US9220784B2","cleaned_patent_number":"9220784","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2015-12-29","legal_status":"Patented case"} US9220784B2 29 Dec, 2015 Patented case 17 Oct, 2027
{"application_id":"80621","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US9339551B2","cleaned_patent_number":"9339551","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2016-05-17","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9339551B2 17 May, 2016 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 17 Oct, 2027
{"application_id":"80622","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US9339552B2","cleaned_patent_number":"9339552","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2016-05-17","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9339552B2 Formulation 17 May, 2016 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 17 Oct, 2027
{"application_id":"80615","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US8563613B2","cleaned_patent_number":"8563613","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2013-10-22","legal_status":"Patented case"} US8563613B2 Formulation 22 Oct, 2013 Patented case 17 Oct, 2027
{"application_id":"80616","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US8871809B2","cleaned_patent_number":"8871809","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-17","publication_date":"2014-10-28","legal_status":"Patented case"} US8871809B2 28 Oct, 2014 Patented case 17 Oct, 2027
{"application_id":"80614","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"866b3cb486d249fabf9e","publication_number":"US8252838B2","cleaned_patent_number":"8252838","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-21","publication_date":"2012-08-28","legal_status":"Expired"} US8252838B2 Formulation 28 Aug, 2012 Expired 21 Apr, 2028
{"application_id":"80591","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"f746902db5954ef7bb2e","publication_number":"US9415029B2","cleaned_patent_number":"9415029","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-10","publication_date":"2016-08-16","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9415029B2 16 Aug, 2016 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 10 Jul, 2029
{"application_id":"80587","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"f746902db5954ef7bb2e","publication_number":"US8618164B2","cleaned_patent_number":"8618164","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-10","publication_date":"2013-12-31","legal_status":"Granted"} US8618164B2 31 Dec, 2013 Granted 10 Jul, 2029
{"application_id":"80584","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"f746902db5954ef7bb2e","publication_number":"US8741956B2","cleaned_patent_number":"8741956","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-10","publication_date":"2014-06-03","legal_status":"Granted"} US8741956B2 03 Jun, 2014 Granted 10 Jul, 2029
{"application_id":"80585","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"f746902db5954ef7bb2e","publication_number":"US8217078B1","cleaned_patent_number":"8217078","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-10","publication_date":"2012-07-10","legal_status":"Granted"} US8217078B2 10 Jul, 2012 Granted 10 Jul, 2029
{"application_id":"80589","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"f746902db5954ef7bb2e","publication_number":"US9370501B2","cleaned_patent_number":"9370501","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-10","publication_date":"2016-06-21","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9370501B2 21 Jun, 2016 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 10 Jul, 2029
{"application_id":"80590","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"f746902db5954ef7bb2e","publication_number":"US9375412B2","cleaned_patent_number":"9375412","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-10","publication_date":"2016-06-28","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9375412B2 28 Jun, 2016 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 10 Jul, 2029
{"application_id":"80586","ingredient":"DICLOFENAC SODIUM","trade_name":"PENNSAID","family_id":"f746902db5954ef7bb2e","publication_number":"US8546450B1","cleaned_patent_number":"8546450","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-09","publication_date":"2013-10-01","legal_status":"Granted"} US8546450B2 01 Oct, 2013 Granted 09 Aug, 2030

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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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