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Aptiom is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-eight patent family members in thirty countries.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Aptiom was eligible for patent challenges on November 8, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 21, 2026. This may change due to patent challenges or generic licensing.
There have been ten patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (eslicarbazepine acetate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for APTIOM
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||65|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for APTIOM|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for APTIOM|
|What excipients (inactive ingredients) are in APTIOM?||APTIOM excipients list|
|DailyMed Link:||APTIOM at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for APTIOM
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for APTIOM
Identify potential brand extensions & 505(b)(2) entrants
|Stanford University||Phase 4|
Pharmacology for APTIOM
|Mechanism of Action||Cytochrome P450 3A4 Inducers |
Cytochrome P450 2C19 Inhibitors
|Physiological Effect||Decreased Central Nervous System Disorganized Electrical Activity |
|Country||Patent Number||Estimated Expiration|
|South Korea||101519040||Get Started for $10|
|Japan||2018172407||Get Started for $10|
|Spain||2371556||Get Started for $10|
|Poland||1915346||Get Started for $10|
|China||101277937||Get Started for $10|
|Poland||2214636||Get Started for $10|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|0751129||360||Finland||Get Started for $10|
|0751129||09C0040||France||Get Started for $10||PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/514/001 DU 20090421; REGISTRATION NO/DATE AT EEC: EU/1/09/514/001 DU 20090421|
|0751129||CA 2009 00023||Denmark||Get Started for $10|
|0751129||C300406||Netherlands||Get Started for $10||PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421|
|0751129||SPC/GB09/047||United Kingdom||Get Started for $10||PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTERED: UK EU/1/09/514/001 20090421; UK EU/1/09/514/002 20090421; UK EU/1/09/514/003 20090421; UK EU/1/09/514/004 20090421; UK EU/1/09/514/005 20090421; UK EU/1/09/514/006 20090421; UK EU/1/09/514/019 20090421; UK EU/1/09/514/020 20090421; UK EU/1/09/514/013 20090421; UK EU/1/09/514/014 20090421; UK EU/1/09/514/015 20090421; UK EU/1/09/514/016 20090421; UK EU/1/09/514/017 20090421; UK EU/1/09/514/018 20090421; UK EU/1/09/514/007 20090421; UK EU/1/09/514/008 20090421; UK EU/1/09/514/009 20090421; UK EU/1/09/514/010 20090421; UK EU/1/09/514/011 20090421; UK EU/1/09/514/012 20090421|
|0751129||SPC027/2009||Ireland||Get Started for $10||SPC027/2009: 20091119, EXPIRES: 20210627|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|