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Last Updated: March 3, 2024

Betrixaban - Generic Drug Details


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What are the generic sources for betrixaban and what is the scope of freedom to operate?

Betrixaban is the generic ingredient in one branded drug marketed by Portola Pharms Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Betrixaban has sixty-seven patent family members in twenty-six countries.

Summary for betrixaban
International Patents:67
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 83
Clinical Trials: 10
Patent Applications: 845
Formulation / Manufacturing:see details
DailyMed Link:betrixaban at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for betrixaban
Generic Entry Date for betrixaban*:
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.

Recent Clinical Trials for betrixaban

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Portola PharmaceuticalsPhase 3
Merck Sharp & Dohme Corp.Phase 2
Merck Sharp & Dohme Corp.Phase 1

See all betrixaban clinical trials

US Patents and Regulatory Information for betrixaban

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for betrixaban

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 ⤷  Try a Trial ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 ⤷  Try a Trial ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 ⤷  Try a Trial ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 ⤷  Try a Trial ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 ⤷  Try a Trial ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for betrixaban

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Portola Pharma UK Limited Dexxience betrixaban EMEA/H/C/004309
Prevention of venous thromboembolism
Refused no no no 2018-09-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for betrixaban

Country Patent Number Title Estimated Expiration
Brazil PI0618362 sais farmacêuticos inovadores e polimorfos de um inibidor de fator xa ⤷  Try a Trial
South Korea 20090107499 Unit dose formulations and methods of treating thrombosis with an oral factor Xa inhibitor ⤷  Try a Trial
South Africa 200803820 Pharmaceutical salts and polymorphs of N-(5-chloro-2-pyridinyl)-2-[[4-[(dimethylamino) iminomethyl] benzoyl] amino]-5-meth oxy-benzamide, A factor Xa inhibitor ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2011084519 ⤷  Try a Trial
Japan 5662980 ⤷  Try a Trial
European Patent Office 2513058 PROCÉDÉS DE SYNTHÈSE D'INHIBITEURS DU FACTEUR XA (METHODS OF SYNTHESIZING FACTOR XA INHIBITORS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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.