Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

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 six 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. Six 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 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
Paragraph IV (Patent) Challenges for 202155
Tradename Dosage Ingredient NDA Submissiondate
ELIQUIS TABLET;ORAL apixaban 202155 2016-12-28

Profile for product number 001

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

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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 verifification 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.