NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 3 pharmaceutical companies such as MERCK SHARP DOHME, MSD SUB MERCK, ENDO OPERATIONS. It is marketed under 4 brand names, including JUVISYNC, JANUMET XR, STEGLUJAN and others. Available in 11 different strengths, such as 40MG;EQ 100MG BASE, 20MG;EQ 100MG BASE, 10MG;EQ 100MG BASE and others, and administered through 2 routes including TABLET;ORAL, TABLET, EXTENDED RELEASE;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":"86131","ingredient":"ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE","trade_name":"JANUMET","family_id":"4bc8ed0eff3e4fdd986b","publication_number":"US7326708B2","cleaned_patent_number":"7326708","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-24","publication_date":"2008-02-05","legal_status":"Court proceedings terminated"} | US7326708B2 | 05 Feb, 2008 | Court proceedings terminated | 24 May, 2027 | |
| {"application_id":"94986","ingredient":"METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE","trade_name":"JANUMET","family_id":"5c8e268d150642aab2ec","publication_number":"US8414921B2","cleaned_patent_number":"8414921","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-01-21","publication_date":"2013-04-09","legal_status":"Patented case"} | US8414921B2 | 09 Apr, 2013 | Patented case | 21 Jan, 2029 | |
| {"application_id":"99113","ingredient":"ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE","trade_name":"STEGLUJAN","family_id":"83e195a225ea43aaadd8","publication_number":"US8080580B2","cleaned_patent_number":"8080580","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-13","publication_date":"2011-12-20","legal_status":"Patented case"} | US8080580B2 Molecular Formulation | 20 Dec, 2011 | Patented case | 13 Jul, 2030 | |
| {"application_id":"99103","ingredient":"ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE","trade_name":"STEGLUJAN","family_id":"23875e449508455d87ea","publication_number":"US9308204B2","cleaned_patent_number":"9308204","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-21","publication_date":"2016-04-12","legal_status":"Patented case"} | US9308204B2 Formulation | 12 Apr, 2016 | Patented case | 21 Oct, 2030 | |
| {"application_id":"99104","ingredient":"ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE","trade_name":"STEGLUJAN","family_id":"23875e449508455d87ea","publication_number":"US9439901B2","cleaned_patent_number":"9439901","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-21","publication_date":"2016-09-13","legal_status":"Patented case"} | US9439901B2 | 13 Sep, 2016 | Patented case | 21 Oct, 2030 |
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.