NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 24 pharmaceutical companies such as MARKSANS PHARMA, SUN PHARM INDS LTD, GRANULES INDIA and others. It is marketed under 6 brand names, including NAPROXEN SODIUM, ALEVE PM, TREXIMET and others. Available in 9 different strengths, such as 220MG, EQ 500MG BASE, EQ 250MG BASE and others, and administered through 3 routes including TABLET;ORAL, TABLET, EXTENDED RELEASE;ORAL, CAPSULE;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":"49269","ingredient":"NAPROXEN SODIUM","trade_name":"NAPROXEN SODIUM","family_id":"9e450c1c4fad469a95ab","publication_number":"US10022344B2","cleaned_patent_number":"10022344","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-03-03","publication_date":"2018-07-17","legal_status":"Patented case"} | US10022344B2 Formulation | 17 Jul, 2018 | Patented case | 03 Mar, 2026 | |
| {"application_id":"49252","ingredient":"NAPROXEN SODIUM","trade_name":"NAPROXEN SODIUM","family_id":"9e450c1c4fad469a95ab","publication_number":"US10028925B2","cleaned_patent_number":"10028925","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-03-03","publication_date":"2018-07-24","legal_status":"Granted"} | US10028925B2 Formulation | 24 Jul, 2018 | Granted | 03 Mar, 2026 | |
| {"application_id":"49270","ingredient":"NAPROXEN SODIUM","trade_name":"NAPROXEN SODIUM","family_id":"9e450c1c4fad469a95ab","publication_number":"US11090280B2","cleaned_patent_number":"11090280","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-03-03","publication_date":"2021-08-17","legal_status":"Granted"} | US11090280B2 Formulation | 17 Aug, 2021 | Granted | 03 Mar, 2026 | |
| {"application_id":"49267","ingredient":"NAPROXEN SODIUM","trade_name":"NAPROXEN SODIUM","family_id":"9e450c1c4fad469a95ab","publication_number":"US9693978B2","cleaned_patent_number":"9693978","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-03-03","publication_date":"2017-07-04","legal_status":"Patented case"} | US9693978B2 Formulation | 04 Jul, 2017 | Patented case | 03 Mar, 2026 | |
| {"application_id":"49268","ingredient":"NAPROXEN SODIUM","trade_name":"NAPROXEN SODIUM","family_id":"9e450c1c4fad469a95ab","publication_number":"US9693979B2","cleaned_patent_number":"9693979","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-03-03","publication_date":"2017-07-04","legal_status":"Granted"} | US9693979B2 Formulation | 04 Jul, 2017 | Granted | 03 Mar, 2026 | |
| {"application_id":"101095","ingredient":"NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE","trade_name":"TREXIMET","family_id":"b8497a850a7a4f929691","publication_number":"US7332183B2","cleaned_patent_number":"7332183","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-04-02","publication_date":"2008-02-19","legal_status":"Granted"} | US7332183B2 | 19 Feb, 2008 | Granted | 02 Apr, 2026 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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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.