NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 8 pharmaceutical companies such as HORIZON, ALKEM LABS LTD, TEVA PHARMS USA and others. It is marketed under 2 brand names, including DUEXIS, IBUPROFEN AND FAMOTIDINE. Available in 1 different strength, such as 26.6MG;800MG, and administered through 1 route including 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":"92513","ingredient":"FAMOTIDINE; IBUPROFEN","trade_name":"DUEXIS","family_id":"a615b631590149efa2ad","publication_number":"US8067451B2","cleaned_patent_number":"8067451","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-18","publication_date":"2011-11-29","legal_status":"Granted"} | US8067451B2 Formulation | 29 Nov, 2011 | Granted | 18 Jul, 2026 | |
| {"application_id":"92536","ingredient":"FAMOTIDINE; IBUPROFEN","trade_name":"DUEXIS","family_id":"a615b631590149efa2ad","publication_number":"US8309127B2","cleaned_patent_number":"8309127","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-18","publication_date":"2012-11-13","legal_status":"Expired"} | US8309127B2 Formulation | 13 Nov, 2012 | Expired | 18 Jul, 2026 | |
| {"application_id":"92537","ingredient":"FAMOTIDINE; IBUPROFEN","trade_name":"DUEXIS","family_id":"a615b631590149efa2ad","publication_number":"US8318202B2","cleaned_patent_number":"8318202","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-18","publication_date":"2012-11-27","legal_status":"Granted"} | US8318202B2 Formulation | 27 Nov, 2012 | Granted | 18 Jul, 2026 | |
| {"application_id":"92538","ingredient":"FAMOTIDINE; IBUPROFEN","trade_name":"DUEXIS","family_id":"a615b631590149efa2ad","publication_number":"US8449910B2","cleaned_patent_number":"8449910","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-18","publication_date":"2013-05-28","legal_status":"Granted"} | US8449910B2 Formulation | 28 May, 2013 | Granted | 18 Jul, 2026 | |
| {"application_id":"92539","ingredient":"FAMOTIDINE; IBUPROFEN","trade_name":"DUEXIS","family_id":"a615b631590149efa2ad","publication_number":"US8501228B2","cleaned_patent_number":"8501228","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-18","publication_date":"2013-08-06","legal_status":"Granted"} | US8501228B2 | 06 Aug, 2013 | Granted | 18 Jul, 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.