NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as MERCK SHARP DOHME. It is marketed under 1 brand name, including JUVISYNC. Available in 6 different strengths, such as 10MG;EQ 100MG BASE, 20MG;EQ 100MG BASE, 40MG;EQ 100MG BASE and others, 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":"86131","ingredient":"SIMVASTATIN; SITAGLIPTIN PHOSPHATE","trade_name":"JUVISYNC","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":"2026-10-11","publication_date":"2008-02-05","legal_status":"Court proceedings terminated"} | US7326708B2 | 05 Feb, 2008 | Court proceedings terminated | 11 Oct, 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.