NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 8 pharmaceutical companies such as ABBVIE, FIRST TIME US, AMNEAL PHARMS and others. It is marketed under 3 brand names, including FETZIMA, MILNACIPRAN HYDROCHLORIDE, LEVOMILNACIPRAN HYDROCHLORIDE. Available in 8 different strengths, such as EQ 20MG BASE, EQ 120MG BASE, EQ 80MG BASE and others, and administered through 2 routes including CAPSULE, EXTENDED RELEASE;ORAL, 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":"44325","ingredient":"LEVOMILNACIPRAN HYDROCHLORIDE","trade_name":"FETZIMA","family_id":"cd12a5cf13664fadbb1f","publication_number":"USRE43879E1","cleaned_patent_number":"RE43879","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-11","publication_date":"2012-12-25","legal_status":"Patented case"} | USRE43879E1 | 25 Dec, 2012 | Patented case | 11 Jan, 2026 | |
| {"application_id":"98846","ingredient":"MILNACIPRAN HYDROCHLORIDE","trade_name":"SAVELLA","family_id":"7efa3e6a302d41b78abd","publication_number":"US7994220B2","cleaned_patent_number":"7994220","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-19","publication_date":"2011-08-09","legal_status":"Granted"} | US7994220B2 | 09 Aug, 2011 | Granted | 19 Sep, 2029 | |
| {"application_id":"44306","ingredient":"LEVOMILNACIPRAN HYDROCHLORIDE","trade_name":"FETZIMA","family_id":"afcb2fa9b518401bb6a5","publication_number":"US8481598B2","cleaned_patent_number":"8481598","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-02","publication_date":"2013-07-09","legal_status":"Granted"} | US8481598B2 | 09 Jul, 2013 | Granted | 02 Mar, 2031 | |
| {"application_id":"44313","ingredient":"LEVOMILNACIPRAN HYDROCHLORIDE","trade_name":"FETZIMA","family_id":"afcb2fa9b518401bb6a5","publication_number":"US8865937B2","cleaned_patent_number":"8865937","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-23","publication_date":"2014-10-21","legal_status":"Granted"} | US8865937B2 Molecular Formulation | 21 Oct, 2014 | Granted | 23 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.