NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as TERSERA. It is marketed under 1 brand name, including XERMELO. Available in 1 different strength, such as EQ 250MG 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":"103133","ingredient":"TELOTRISTAT ETIPRATE","trade_name":"XERMELO","family_id":"a174ad9a606d4d39abc1","publication_number":"US7553840B2","cleaned_patent_number":"7553840","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-11","publication_date":"2009-06-30","legal_status":"Patented case"} | US7553840B2 Molecular | 30 Jun, 2009 | Patented case | 11 Dec, 2027 | |
| {"application_id":"103098","ingredient":"TELOTRISTAT ETIPRATE","trade_name":"XERMELO","family_id":"a174ad9a606d4d39abc1","publication_number":"US7968559B2","cleaned_patent_number":"7968559","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-11","publication_date":"2011-06-28","legal_status":"Granted"} | US7968559B2 | 28 Jun, 2011 | Granted | 11 Dec, 2027 | |
| {"application_id":"103139","ingredient":"TELOTRISTAT ETIPRATE","trade_name":"XERMELO","family_id":"d28f55472fcf4b4298f0","publication_number":"US8653094B2","cleaned_patent_number":"8653094","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-19","publication_date":"2014-02-18","legal_status":"Granted"} | US8653094B2 | 18 Feb, 2014 | Granted | 19 Dec, 2028 | |
| {"application_id":"103163","ingredient":"TELOTRISTAT ETIPRATE","trade_name":"XERMELO","family_id":"d28f55472fcf4b4298f0","publication_number":"US8193204B2","cleaned_patent_number":"8193204","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-27","publication_date":"2012-06-05","legal_status":"Granted"} | US8193204B2 Molecular | 05 Jun, 2012 | Granted | 27 Feb, 2031 | |
| {"application_id":"103134","ingredient":"TELOTRISTAT ETIPRATE","trade_name":"XERMELO","family_id":"a174ad9a606d4d39abc1","publication_number":"US7709493B2","cleaned_patent_number":"7709493","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-28","publication_date":"2010-05-04","legal_status":"Patented case"} | US7709493B2 Molecular | 04 May, 2010 | Patented case | 28 Feb, 2031 |
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.