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 |
| DailyMed Link: | BETRIXABAN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BETRIXABAN
*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 | 208383-002 | 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 | 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 | 208383-001 | 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 | |||
| >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 | ⤷ 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 | 208383-002 | 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 |
|---|---|---|---|
| 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) | ⤷ Sign Up |
| European Patent Office | 2431358 | Procédé de préparation d'un inhibiteur du facteur XA (Method of preparing a factor XA inhibitor) | ⤷ Sign Up |
| Taiwan | 200736221 | Novel pharmaceutical salts and polymorphs of a Factor Xa inhibitor | ⤷ Sign Up |
| 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 | ⤷ Sign Up |
| Japan | 5662980 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
