NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as FOLDRX PHARMS. It is marketed under 1 brand name, including VYNDAQEL. Available in 1 different strength, such as 20MG, and administered through 1 route including 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":"52887","ingredient":"TAFAMIDIS MEGLUMINE","trade_name":"VYNDAQEL","family_id":"1a9c8a3622794cda93c8","publication_number":"US7214695B2","cleaned_patent_number":"7214695","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-19","publication_date":"2007-05-08","legal_status":"Granted"} | US7214695B2 Molecular Formulation | 08 May, 2007 | Granted | 19 Dec, 2025 | |
| {"application_id":"52858","ingredient":"TAFAMIDIS MEGLUMINE","trade_name":"VYNDAQEL","family_id":"1a9c8a3622794cda93c8","publication_number":"US7214696B2","cleaned_patent_number":"7214696","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-19","publication_date":"2007-05-08","legal_status":"Expired"} | US7214696B2 | 08 May, 2007 | Expired | 19 Dec, 2025 |
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.