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 six 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. Seven 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 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;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:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Dec 28, 2012	TE:	AB	RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	Nov 21, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
Patent:	See Plans and Pricing	Patent Expiration:	Nov 21, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
Patent:	See Plans and Pricing	Patent Expiration:	Nov 21, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	PROPHYLAXIS OF PULMONARY EMBOLISM

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	See Plans and Pricing	See Plans and Pricing
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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