NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as TAKEDA PHARMS USA, APOTEX. It is marketed under 2 brand names, including ICLUSIG, PONATINIB HYDROCHLORIDE. Available in 4 different strengths, such as EQ 15MG BASE, EQ 45MG BASE, EQ 30MG 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":"94362","ingredient":"PONATINIB HYDROCHLORIDE","trade_name":"ICLUSIG","family_id":"85d828ba8bb5464882a6","publication_number":"US9029533B2","cleaned_patent_number":"9029533","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-22","publication_date":"2015-05-12","legal_status":"Granted"} | US9029533B2 | 12 May, 2015 | Granted | 22 Dec, 2026 | |
| {"application_id":"94422","ingredient":"PONATINIB HYDROCHLORIDE","trade_name":"ICLUSIG","family_id":"85d828ba8bb5464882a6","publication_number":"US8114874B2","cleaned_patent_number":"8114874","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-24","publication_date":"2012-02-14","legal_status":"Granted"} | US8114874B2 Molecular Formulation | 14 Feb, 2012 | Granted | 24 Jan, 2027 | |
| {"application_id":"94466","ingredient":"PONATINIB HYDROCHLORIDE","trade_name":"ICLUSIG","family_id":"fb986842f9d849359b2c","publication_number":"US11192895B2","cleaned_patent_number":"11192895","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-12-12","publication_date":"2021-12-07","legal_status":"Granted"} | US11192895B2 | 07 Dec, 2021 | Granted | 12 Dec, 2033 | |
| {"application_id":"94468","ingredient":"PONATINIB HYDROCHLORIDE","trade_name":"ICLUSIG","family_id":"fb986842f9d849359b2c","publication_number":"US11192897B2","cleaned_patent_number":"11192897","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-12-12","publication_date":"2021-12-07","legal_status":"Granted"} | US11192897B2 Molecular | 07 Dec, 2021 | Granted | 12 Dec, 2033 | |
| {"application_id":"94470","ingredient":"PONATINIB HYDROCHLORIDE","trade_name":"ICLUSIG","family_id":"fb986842f9d849359b2c","publication_number":"US11384086B2","cleaned_patent_number":"11384086","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-12-12","publication_date":"2022-07-12","legal_status":"Granted"} | US11384086B2 Molecular Formulation | 12 Jul, 2022 | Granted | 12 Dec, 2033 | |
| {"application_id":"94447","ingredient":"PONATINIB HYDROCHLORIDE","trade_name":"ICLUSIG","family_id":"fb986842f9d849359b2c","publication_number":"US9493470B2","cleaned_patent_number":"9493470","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-12-12","publication_date":"2016-11-15","legal_status":"Granted"} | US9493470B2 Molecular Formulation | 15 Nov, 2016 | Granted | 12 Dec, 2033 |
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.