NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as CHEMISCH FBRK KRSSLR, PROVENSIS. It is marketed under 2 brand names, including ASCLERA, VARITHENA. Available in 4 different strengths, such as 10MG/2ML (5MG/ML), 20MG/2ML (10MG/ML), 180MG/18ML (10MG/ML) and others, and administered through 1 route including SOLUTION;INTRAVENOUS.
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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":"75276","ingredient":"POLIDOCANOL","trade_name":"VARITHENA","family_id":"3021b58256a347f8a3ac","publication_number":"US7814943B2","cleaned_patent_number":"7814943","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-19","publication_date":"2010-10-19","legal_status":"Granted"} | US7814943B2 Formulation | 19 Oct, 2010 | Granted | 19 Nov, 2027 | |
| {"application_id":"75298","ingredient":"POLIDOCANOL","trade_name":"VARITHENA","family_id":"89f0389203ad4401a9f1","publication_number":"US9480652B2","cleaned_patent_number":"9480652","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-12","publication_date":"2016-11-01","legal_status":"Granted"} | US9480652B2 Formulation | 01 Nov, 2016 | Granted | 12 May, 2032 |
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.