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

Generic Entry Date for BETRIXABAN^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

See all BETRIXABAN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BETRIXABAN

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for BETRIXABAN

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Glossary

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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	208383-001	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	208383-002	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

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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	208383-001	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

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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

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1134031	UNIT DOSE FORMULATIONS AND METHODS OF TREATING THROMBOSIS WITH AN ORAL FACTOR XA INHIBITOR	⤷ Sign Up
South Korea	101358574		⤷ Sign Up
Peru	20070717	SAL DE MALEATO Y POLIMORFO DE [2-({4-[(DIMETILAMINO)IMINOMETIL]FENIL}CARBONILAMINO)-5-METOXIFENIL]-N-(5-CLORO-(2-PIRIDIL))CARBOXAMIDA	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007056517		⤷ Sign Up
Israel	199219	בטריקסאבאן או מלחיו, לשימוש בעיכוב קרישת דם (Betrixaban or salt thereof for use in inhibiting blood coagulation)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Summary for BETRIXABAN

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BETRIXABAN

Recent Clinical Trials for BETRIXABAN

Anatomical Therapeutic Chemical (ATC) Classes for BETRIXABAN

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BETRIXABAN