NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 10 pharmaceutical companies such as ADIENNE SA, DR REDDYS, HENGRUI PHARMA and others. It is marketed under 4 brand names, including TEPADINA, THIOTEPA, TEPYLUTE and others. Available in 5 different strengths, such as 100MG/VIAL, 15MG/VIAL, 15MG/1.5ML (10MG/ML) and others, and administered through 4 routes including POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL, INJECTABLE;INJECTION, SOLUTION;INTRAVENOUS and others.
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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":"242114","ingredient":"THIOTEPA","trade_name":"TEPADINA AND SODIUM CHLORIDE","family_id":"","publication_number":"US9931458B1","cleaned_patent_number":"9931458","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-31","publication_date":"2018-04-03","legal_status":"Granted"} | US9931458B2 Formulation | 03 Apr, 2018 | Granted | 31 May, 2037 | |
| {"application_id":"124166","ingredient":"THIOTEPA","trade_name":"TEPYLUTE","family_id":"","publication_number":"US11975013B2","cleaned_patent_number":"11975013","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-08-16","publication_date":"2024-05-07","legal_status":"Granted"} | US11975013B2 Formulation | 07 May, 2024 | Granted | 16 Aug, 2041 |
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.