NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as AGIOS PHARMS INC. It is marketed under 1 brand name, including PYRUKYND. Available in 3 different strengths, such as EQ 5MG BASE, EQ 20MG BASE, EQ 50MG 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 |
|---|
Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"116751","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"","publication_number":"USRE49582E","cleaned_patent_number":"RE49582","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-24","publication_date":"2023-07-18","legal_status":"Granted"} | USRE49582E1 Molecular Formulation | 18 Jul, 2023 | Granted | 24 Feb, 2031 | |
| {"application_id":"98096","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"bd36e4624de34cfaa32c","publication_number":"US10632114B2","cleaned_patent_number":"10632114","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-03","publication_date":"2020-04-28","legal_status":"Patented case"} | US10632114B2 | 28 Apr, 2020 | Patented case | 03 May, 2032 | |
| {"application_id":"98094","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"bd36e4624de34cfaa32c","publication_number":"US9682080B2","cleaned_patent_number":"9682080","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-03","publication_date":"2017-06-20","legal_status":"Granted"} | US9682080B2 | 20 Jun, 2017 | Granted | 03 May, 2032 | |
| {"application_id":"98095","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"bd36e4624de34cfaa32c","publication_number":"US9980961B2","cleaned_patent_number":"9980961","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-03","publication_date":"2018-05-29","legal_status":"Patented case"} | US9980961B2 | 29 May, 2018 | Patented case | 03 May, 2032 | |
| {"application_id":"98055","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"bd36e4624de34cfaa32c","publication_number":"US9193701B2","cleaned_patent_number":"9193701","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-10-26","publication_date":"2015-11-24","legal_status":"Granted"} | US9193701B2 | 24 Nov, 2015 | Granted | 26 Oct, 2032 | |
| {"application_id":"98098","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"bd36e4624de34cfaa32c","publication_number":"US11793806B2","cleaned_patent_number":"11793806","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-04-12","publication_date":"2023-10-24","legal_status":"Granted"} | US11793806B2 | 24 Oct, 2023 | Granted | 12 Apr, 2033 | |
| {"application_id":"98103","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"d4a06fa2f55d4fb3bb88","publication_number":"US11234976B2","cleaned_patent_number":"11234976","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-11","publication_date":"2022-02-01","legal_status":"Granted"} | US11234976B2 | 01 Feb, 2022 | Granted | 11 Oct, 2038 | |
| {"application_id":"98117","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"ea5f4e54999a4f138373","publication_number":"US11254652B2","cleaned_patent_number":"11254652","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-11-21","publication_date":"2022-02-22","legal_status":"Granted"} | US11254652B2 Molecular Formulation | 22 Feb, 2022 | Granted | 21 Nov, 2038 | |
| {"application_id":"121260","ingredient":"MITAPIVAT SULFATE","trade_name":"PYRUKYND","family_id":"","publication_number":"US11878049B1","cleaned_patent_number":"11878049","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-07-31","publication_date":"2024-01-23","legal_status":"Granted"} | US11878049B2 | 23 Jan, 2024 | Granted | 31 Jul, 2041 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.