NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as JANSSEN THERAP. It is marketed under 1 brand name, including SIRTURO. Available in 2 different strengths, such as EQ 100MG BASE, EQ 20MG BASE, 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":"99312","ingredient":"BEDAQUILINE FUMARATE","trade_name":"SIRTURO","family_id":"d4e30eac65b4457bba82","publication_number":"US7498343B2","cleaned_patent_number":"7498343","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-01","publication_date":"2009-03-03","legal_status":"Granted"} | US7498343B2 Molecular Formulation | 03 Mar, 2009 | Granted | 01 Dec, 2026 | |
| {"application_id":"99361","ingredient":"BEDAQUILINE FUMARATE","trade_name":"SIRTURO","family_id":"9998481bcb0347eea8be","publication_number":"US8546428B2","cleaned_patent_number":"8546428","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-19","publication_date":"2013-10-01","legal_status":"Patented case"} | US8546428B2 Molecular Formulation | 01 Oct, 2013 | Patented case | 19 Mar, 2029 |
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.