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Serving leading biopharmaceutical companies globally:

Colorcon
Deloitte
Fish and Richardson
US Department of Justice
Baxter
Argus Health
Novartis
QuintilesIMS
Daiichi Sankyo
Merck

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202155

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NDA 202155 describes ELIQUIS, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ELIQUIS profile page.

The generic ingredient in ELIQUIS is apixaban. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the apixaban profile page.
Summary for 202155
Tradename:ELIQUIS
Applicant:Bristol Myers Squibb
Ingredient:apixaban
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 202155
Mechanism of ActionFactor Xa Inhibitors
Suppliers and Packaging for NDA: 202155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIQUIS apixaban TABLET;ORAL 202155 NDA E.R. Squibb & Sons, L.L.C. 0003-0893 0003-0893-21 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0893-21)
ELIQUIS apixaban TABLET;ORAL 202155 NDA E.R. Squibb & Sons, L.L.C. 0003-0893 0003-0893-31 10 BLISTER PACK in 1 CARTON (0003-0893-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 28, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 21, 2017
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
Regulatory Exclusivity Expiration:Aug 21, 2017
Regulatory Exclusivity Use:INDICATED TO REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) FOLLOWING INITIAL THERAPY
Regulatory Exclusivity Expiration:Dec 28, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving leading biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Johnson and Johnson
Teva
Argus Health
Federal Trade Commission
Cerilliant
Deloitte
Medtronic

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