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: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208383

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NDA 208383 describes BEVYXXA, which is a drug marketed by Portola Pharms Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the BEVYXXA profile page.

The generic ingredient in BEVYXXA is betrixaban. One supplier is listed for this compound. Additional details are available on the betrixaban profile page.
Summary for 208383
Tradename:BEVYXXA
Applicant:Portola Pharms Inc
Ingredient:betrixaban
Patents:10
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208383
Generic Entry Date for 208383*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 208383
Mechanism of ActionFactor Xa Inhibitors
Suppliers and Packaging for NDA: 208383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BEVYXXA betrixaban CAPSULE;ORAL 208383 NDA Portola Pharmaceuticals, Inc. 69853-0201 69853-0201-1 1 BOTTLE in 1 CARTON (69853-0201-1) > 100 CAPSULE, GELATIN COATED in 1 BOTTLE
BEVYXXA betrixaban CAPSULE;ORAL 208383 NDA Portola Pharmaceuticals, Inc. 69853-0202 69853-0202-1 1 BOTTLE in 1 CARTON (69853-0202-1) > 100 CAPSULE, GELATIN COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Jun 23, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 23, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Sep 15, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PREVENTING CONDITION CHARACTERIZED BY UNDESIRED THROMBOSIS
Patent:  Start TrialPatent Expiration:Sep 15, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)

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Serving leading biopharmaceutical companies globally:

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