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 seven 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. Eight 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:	⤷ Try a Trial	Patent Expiration:	Nov 21, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
Patent:	⤷ Try a Trial	Patent Expiration:	Nov 21, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
Patent:	⤷ Try a Trial	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	⤷ Try a Trial	⤷ Try a Trial
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.