NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 13 pharmaceutical companies such as BIONPHARMA, ENDO OPERATIONS, ONESOURCE SPECIALTY and others. It is marketed under 2 brand names, including DICLOFENAC POTASSIUM, CATAFLAM. Available in 2 different strengths, such as 25MG, 50MG, and administered through 3 routes including CAPSULE;ORAL, FOR SOLUTION;ORAL, TABLET;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"56920","ingredient":"DICLOFENAC POTASSIUM","trade_name":"CAMBIA","family_id":"2ce676bd32fe4fa3b348","publication_number":"US8097651B2","cleaned_patent_number":"8097651","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-16","publication_date":"2012-01-17","legal_status":"Granted"} | US8097651B2 Molecular Formulation | 17 Jan, 2012 | Granted | 16 Jun, 2026 | |
| {"application_id":"56951","ingredient":"DICLOFENAC POTASSIUM","trade_name":"CAMBIA","family_id":"2ce676bd32fe4fa3b348","publication_number":"US8927604B2","cleaned_patent_number":"8927604","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-16","publication_date":"2015-01-06","legal_status":"Granted"} | US8927604B2 | 06 Jan, 2015 | Granted | 16 Jun, 2026 | |
| {"application_id":"56950","ingredient":"DICLOFENAC POTASSIUM","trade_name":"CAMBIA","family_id":"2ce676bd32fe4fa3b348","publication_number":"US7759394B2","cleaned_patent_number":"7759394","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-16","publication_date":"2010-07-20","legal_status":"Granted"} | US7759394B2 Molecular Formulation | 20 Jul, 2010 | Granted | 16 Jun, 2026 | |
| {"application_id":"56952","ingredient":"DICLOFENAC POTASSIUM","trade_name":"CAMBIA","family_id":"2ce676bd32fe4fa3b348","publication_number":"US9827197B2","cleaned_patent_number":"9827197","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-16","publication_date":"2017-11-28","legal_status":"Granted"} | US9827197B2 Formulation | 28 Nov, 2017 | Granted | 16 Jun, 2026 | |
| {"application_id":"53900","ingredient":"DICLOFENAC POTASSIUM","trade_name":"ZIPSOR","family_id":"6f53e1029da84f8985db","publication_number":"US8623920B2","cleaned_patent_number":"8623920","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-24","publication_date":"2014-01-07","legal_status":"Patented case"} | US8623920B2 | 07 Jan, 2014 | Patented case | 24 Feb, 2029 | |
| {"application_id":"53901","ingredient":"DICLOFENAC POTASSIUM","trade_name":"ZIPSOR","family_id":"6f53e1029da84f8985db","publication_number":"US9561200B2","cleaned_patent_number":"9561200","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-24","publication_date":"2017-02-07","legal_status":"Patented case"} | US9561200B2 | 07 Feb, 2017 | Patented case | 24 Feb, 2029 | |
| {"application_id":"53899","ingredient":"DICLOFENAC POTASSIUM","trade_name":"ZIPSOR","family_id":"6f53e1029da84f8985db","publication_number":"US8110606B2","cleaned_patent_number":"8110606","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-24","publication_date":"2012-02-07","legal_status":"Granted"} | US8110606B2 | 07 Feb, 2012 | Granted | 24 Feb, 2029 | |
| {"application_id":"53896","ingredient":"DICLOFENAC POTASSIUM","trade_name":"ZIPSOR","family_id":"6f53e1029da84f8985db","publication_number":"US7884095B2","cleaned_patent_number":"7884095","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-24","publication_date":"2011-02-08","legal_status":"Patented case"} | US7884095B2 | 08 Feb, 2011 | Patented case | 24 Feb, 2029 | |
| {"application_id":"53898","ingredient":"DICLOFENAC POTASSIUM","trade_name":"ZIPSOR","family_id":"6f53e1029da84f8985db","publication_number":"US7939518B2","cleaned_patent_number":"7939518","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-24","publication_date":"2011-05-10","legal_status":"Patented case"} | US7939518B2 | 10 May, 2011 | Patented case | 24 Feb, 2029 | |
| {"application_id":"53897","ingredient":"DICLOFENAC POTASSIUM","trade_name":"ZIPSOR","family_id":"6f53e1029da84f8985db","publication_number":"US7662858B2","cleaned_patent_number":"7662858","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-24","publication_date":"2010-02-16","legal_status":"Patented case"} | US7662858B2 | 16 Feb, 2010 | Patented case | 24 Feb, 2029 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.