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Apixabanis the generic ingredient in two branded drugs marketed by Accord Hlthcare, Bionpharma Inc, Indoco, Micro Labs, Mylan, and Bristol Myers Squibb, and is included in six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Apixaban has one hundred and sixty-six patent family members in forty-two countries.
There are thirty drug master file entries for apixaban. Seven suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for APIXABAN
|Drug Master File Entries:||30|
|Suppliers / Packagers:||7|
|Bulk Api Vendors:||109|
|Formulation / Manufacturing:||see details|
|Drug Sales Revenues:||Drug sales revenues for APIXABAN|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for APIXABAN|
|What excipients (inactive ingredients) are in APIXABAN?||APIXABAN excipients list|
|DailyMed Link:||APIXABAN at DailyMed|
Recent Clinical Trials for APIXABAN
Identify potential brand extensions & 505(b)(2) entrants
|Korea University Guro Hospital||Phase 2|
|Cambridge University Hospitals NHS Foundation Trust (joint Sponsor)||Phase 3|
Generic filers with tentative approvals for APIXABAN
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for APIXABAN
|Drug Class||Factor Xa Inhibitor |
|Mechanism of Action||Factor Xa Inhibitors |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Micro Labs||APIXABAN||apixaban||TABLET;ORAL||210013-001||Dec 23, 2019||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Bristol Myers Squibb||ELIQUIS||apixaban||TABLET;ORAL||202155-002||Dec 28, 2012||AB||RX||Yes||Yes||Start Trial||Start Trial||Y||Y||Start Trial|
|Micro Labs||APIXABAN||apixaban||TABLET;ORAL||210013-002||Dec 23, 2019||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Bristol Myers Squibb||ELIQUIS||apixaban||TABLET;ORAL||202155-002||Dec 28, 2012||Start Trial||Start Trial|
|Bristol Myers Squibb||ELIQUIS||apixaban||TABLET;ORAL||202155-001||Dec 28, 2012||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1427415||2011/032||Ireland||Start Trial||PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518|
|1427415||31/2011||Austria||Start Trial||PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520|
|1427415||11C0042||France||Start Trial||PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110520|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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