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Last Updated: November 30, 2022

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-eight patent family members in twenty-six countries.

Summary for betrixaban
International Patents:68
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 78
Clinical Trials: 10
Patent Applications: 1,028
Formulation / Manufacturing:see details
DailyMed Link:betrixaban at DailyMed
Recent Clinical Trials for betrixaban

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

SponsorPhase
Portola PharmaceuticalsPhase 3
Merck Sharp & Dohme Corp.Phase 2
Portola PharmaceuticalsPhase 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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) See Plans and Pricing
Costa Rica 10914 UNIT DOSE FORMULATIONS AND METHODS OF TREATING THROMBOSIS WITH AN ORAL FACTOR XA INHIBITOR See Plans and Pricing
Morocco 31086 FORMULATIONS DE DOSES UNITAIRES ET PROCEDES DE TRAITEMENT D'UNE THROMBOSE AVEC UN INHIBITEUR ORAL DU FACTEUR XA. See Plans and Pricing
South Korea 101358574 See Plans and Pricing
European Patent Office 2431358 Procédé de préparation d'un inhibiteur du facteur XA (Method of preparing a factor XA inhibitor) See Plans and Pricing
Portugal 2101760 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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