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Last Updated: March 29, 2024

BETRIXABAN - Generic Drug Details


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What are the generic drug 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 208383-002 Jun 23, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 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
>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 208383-002 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
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 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
European Patent Office 1948608 SELS PHARMACEUTIQUES ET POLYMORPHES DU N-(5-CHLORO-2-PYRIDINYL)-2-[[4-[(DIMETHYLAMINO)IMINOMETHYL]BENZOYL]AMINO]-5-METHOXY-BENZAMIDE, UN INHIBITEUR DU FACTEUR X (PHARMACEUTICAL SALTS AND POLYMORPHS OF N-(5-CHLORO-2-PYRIDINYL)-2-[[4-[(DIMETHYLAMINO)IMINOMETHYL]BENZOYL]AMINO]-5-METHOXY-BENZAMIDE , A FACTOR XA INHIBITOR) ⤷  Try a Trial
Taiwan 200736221 Novel pharmaceutical salts and polymorphs of a Factor Xa inhibitor ⤷  Try a Trial
Israel 190524 SALT OF N-(5-CHLOROPYRIDIN-2-YL)-2-([-4-[(N, N-DIMETHYLCARBAMIMIDOYL)]BENZOYL] AMINO)-5-METHOXYBENZAMIDE AND MALEIC ACID, POLYMORPH THEREOF, PHARMACEUTICAL COMPOSITION COMPRISING IT AND ITS USE IN THE MANUFACTURE OF A MEDICAMENT FOR TREATING AND PREVENTING A CONDITION CHARACTERIZED BY UNDESIRED THROMBOSIS ⤷  Try a Trial
New Zealand 592533 METHOD FOR THE PREPARATION OF N-(5-CHLORO-2-PYRIDINYL)-2-[[4-[(DIMETHYLAMINO) IMINOMETHYL] BENZOYL] AMINO]-5-METHOXY-BENZAMIDE, A FACTOR Xa INHIBITOR ⤷  Try a Trial
China 102336702 Pharmaceutical salts and polymorphs of a factor XA inhibitor n-(5-chloro-pyridin-2-yl)-2-(4-cyano-benzoyl-amino)-5-methoxy-benzamide hydrochloride ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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