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
| Sponsor | Phase |
|---|---|
| Portola Pharmaceuticals | Phase 3 |
| Merck Sharp & Dohme Corp. | Phase 2 |
| Portola Pharmaceuticals | Phase 1 |
US Patents and Regulatory Information for betrixaban
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 | See Plans and Pricing | See Plans and Pricing |
| Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-001 | Jun 23, 2017 | See Plans and Pricing | See Plans and Pricing |
| Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | See Plans and Pricing | See Plans and Pricing |
| Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | See Plans and Pricing | See Plans and Pricing |
| Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-002 | Jun 23, 2017 | See Plans and Pricing | See Plans and Pricing |
| Portola Pharms Inc | BEVYXXA | betrixaban | CAPSULE;ORAL | 208383-001 | Jun 23, 2017 | See Plans and Pricing | See Plans and Pricing |
| >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) | 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 |
