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Last Updated: November 2, 2024

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 nine 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. Ten 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
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:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Nov 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
Patent:⤷  Sign UpPatent Expiration:Nov 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
Patent:⤷  Sign UpPatent Expiration:Nov 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF PULMONARY EMBOLISM

Expired US Patents for NDA 202155

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-001 Dec 28, 2012 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ELIQUIS apixaban TABLET;ORAL 202155-002 Dec 28, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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