Betrixaban - Generic Drug Details
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What are the generic sources for betrixaban and what is the scope of patent protection?
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
Sponsor | Phase |
---|---|
Portola Pharmaceuticals | Phase 3 |
Merck Sharp & Dohme Corp. | Phase 2 |
Portola Pharmaceuticals | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for betrixaban
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-001 | Jun 23, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-001 | Jun 23, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-001 | Jun 23, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-001 | Jun 23, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-001 | Jun 23, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-001 | Jun 23, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Israel | 199219 | בטריקסאבאן או מלחיו, לשימוש בעיכוב קרישת דם (Betrixaban or salt thereof for use in inhibiting blood coagulation) | ⤷ Sign Up |
Argentina | 106960 | SALES Y POLIMORFOS FARMACÉUTICOS DE UN INHIBIDOR DEL FACTOR Xa | ⤷ Sign Up |
Taiwan | 200736221 | Novel pharmaceutical salts and polymorphs of a Factor Xa inhibitor | ⤷ Sign Up |
Russian Federation | 2440986 | СОЛЬ ИНГИБИТОРА ФАКТОРА Ха, СПОСОБ ЕЕ ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ЕЕ ОСНОВЕ, СОСТОЯЩИЕ ИЗ НАЗВАННОЙ КОМПОЗИЦИИ ТАБЛЕТКА, КАПСУЛА И ЛЕПЕШКА, СПОСОБ ЛЕЧЕНИЯ ТРОМБОЗА И СПОСОБ ИНГИБИРОВАНИЯ КОАГУЛЯЦИИ ОБРАЗЦОВ КРОВИ (FACTOR Xa INHIBITOR SALT, METHOD FOR MAKING IT, BASED PHARMACEUTICAL COMPOSITION, TABLET, CAPSULE AND LOZENGE CONSISTING OF THIS COMPOSITION, METHOD FOR TREATING THROMBOSIS AND METHOD FOR INHIBITING BLOOD SAMPLE COAGULATION) | ⤷ Sign Up |
Russian Federation | 2012104816 | СТАНДАРТНЫЕ ЛЕКАРСТВЕННЫЕ ПРЕПАРАТЫ И СПОСОБЫ ЛЕЧЕНИЯ ТРОМБОЗА ПЕРОРАЛЬНЫМ ВВЕДЕНИЕМ ИНГИБИТОРА ФАКТОРА ХА | ⤷ Sign Up |
Japan | 2015091840 | 第Xa因子阻害剤の合成方法 (METHOD OF SYNTHESIZING FACTOR Xa INHIBITOR) | ⤷ Sign Up |
Argentina | 079491 | METODOS DE SINTESIS DE INHIBIDORES DEL FACTOR XA TAL COMO EL BETRIXABAN Y COMPOSICIONES FARMACEUTICAS QUE CONTIENEN LA BASE LIBRE DE BETRIXABAN O SU SAL SUSTANCIALMENTE PURA. | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |