NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 4 pharmaceutical companies such as LEGACY PHARMA, TARO, AMNEAL and others. It is marketed under 2 brand names, including NAFTIN, NAFTIFINE HYDROCHLORIDE. Available in 2 different strengths, such as 2%, 1%, and administered through 2 routes including CREAM;TOPICAL, GEL;TOPICAL.
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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":"59635","ingredient":"NAFTIFINE HYDROCHLORIDE","trade_name":"NAFTIN","family_id":"a6100033853e43c9b78e","publication_number":"US10166205B2","cleaned_patent_number":"10166205","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-31","publication_date":"2019-01-01","legal_status":"Granted"} | US10166205B2 Formulation | 01 Jan, 2019 | Granted | 31 Jan, 2033 | |
| {"application_id":"59636","ingredient":"NAFTIFINE HYDROCHLORIDE","trade_name":"NAFTIN","family_id":"a6100033853e43c9b78e","publication_number":"US10166206B2","cleaned_patent_number":"10166206","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-31","publication_date":"2019-01-01","legal_status":"Patented case"} | US10166206B2 Formulation | 01 Jan, 2019 | Patented case | 31 Jan, 2033 | |
| {"application_id":"59637","ingredient":"NAFTIFINE HYDROCHLORIDE","trade_name":"NAFTIN","family_id":"a6100033853e43c9b78e","publication_number":"US10695303B2","cleaned_patent_number":"10695303","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-31","publication_date":"2020-06-30","legal_status":"Granted"} | US10695303B2 Formulation | 30 Jun, 2020 | Granted | 31 Jan, 2033 | |
| {"application_id":"59638","ingredient":"NAFTIFINE HYDROCHLORIDE","trade_name":"NAFTIN","family_id":"a6100033853e43c9b78e","publication_number":"US10729667B2","cleaned_patent_number":"10729667","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-31","publication_date":"2020-08-04","legal_status":"Granted"} | US10729667B2 Formulation | 04 Aug, 2020 | Granted | 31 Jan, 2033 | |
| {"application_id":"59641","ingredient":"NAFTIFINE HYDROCHLORIDE","trade_name":"NAFTIN","family_id":"a6100033853e43c9b78e","publication_number":"US8778365B2","cleaned_patent_number":"8778365","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-31","publication_date":"2014-07-15","legal_status":"Patented case"} | US8778365B2 Formulation | 15 Jul, 2014 | Patented case | 31 Jan, 2033 | |
| {"application_id":"59628","ingredient":"NAFTIFINE HYDROCHLORIDE","trade_name":"NAFTIN","family_id":"a6100033853e43c9b78e","publication_number":"US9161914B2","cleaned_patent_number":"9161914","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-31","publication_date":"2015-10-20","legal_status":"Granted"} | US9161914B2 | 20 Oct, 2015 | Granted | 31 Jan, 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.