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Generated: August 21, 2018

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 three 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 twenty-eight drug master file entries for this compound. Three 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:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 202155
Generic Entry Date for 202155*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 N 0003-0893-21
ELIQUIS apixaban TABLET;ORAL 202155 NDA E.R. Squibb & Sons, L.L.C. 0003-0893 N 0003-0893-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 28, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 22, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
Patent:➤ Try a Free TrialPatent Expiration:Dec 22, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
Patent:➤ Try a Free TrialPatent Expiration:Dec 22, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF DEEP VEIN THROMBOSIS (DVT)

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