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Last Updated: December 14, 2025

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 Bristol and is included in two NDAs. It is available from eight 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 thirty drug master file entries for this compound. Eleven 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 Action	Factor 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, FOR SUSPENSION;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, FOR SUSPENSION;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:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Dec 28, 2012	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 17, 2028
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Oct 17, 2028
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	6,967,208*PED	Patent Expiration:	May 21, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202155

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	6,413,980	⤷ Get Started Free
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	6,413,980	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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