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Last Updated: July 7, 2020

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 five suppliers. There are two 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 thirty drug master file entries for this compound. Five 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:2
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
Paragraph IV (Patent) Challenges for 202155
Tradename Dosage Ingredient NDA Submissiondate
ELIQUIS TABLET;ORAL apixaban 202155 2016-12-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 28, 2012TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
Patent:  Start TrialPatent Expiration:Nov 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
Patent:  Start TrialPatent Expiration:Nov 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF PULMONARY EMBOLISM

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