Bevyxxa Patent Expiration

Bevyxxa is a drug owned by Portola Pharmaceuticals Inc. It is protected by 10 US drug patents filed in 2017. Out of these, 5 drug patents are active and 5 have expired. Bevyxxa's patents have been open to challenges since 23 June, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 29, 2031. Details of Bevyxxa's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7598276 Pharmaceutical salts and polymorphs of a factor Xa inhibitor
Nov, 2026

(1 year, 11 months from now)

Active
US8691847 Benzamides and related inhibitors of factor Xa
Sep, 2020

(4 years ago)

Expired
US6835739 Benzamides and related inhibitors of factor Xa
Sep, 2020

(4 years ago)

Expired
US8518977 Benzamides and related inhibitors of factor XA
Sep, 2020

(4 years ago)

Expired
US6376515 Benzamides and related inhibitors of factor Xa
Sep, 2020

(4 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8404724 Unit dose formulations and methods of treating thrombosis with an oral factor Xa inhibitor
Mar, 2031

(6 years from now)

Active
US8987463 Methods of synthesizing factor Xa inhibitors
Dec, 2030

(6 years from now)

Active
US8557852 Methods of using crystalline forms of a salt of a factor Xa inhibitor
Sep, 2028

(3 years from now)

Active
US9555023 Pharmaceutical salts and polymorphs of a factor Xa inhibitor
Nov, 2026

(1 year, 11 months from now)

Active
US9629831 Benzamides and related inhibitors of factor XA
Sep, 2020

(4 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Bevyxxa's patents.

Given below is the list of recent legal activities going on the following patents of Bevyxxa.

Activity Date Patent Number
Patent litigations
Expire Patent 16 May, 2022 US8691847
Maintenance Fee Reminder Mailed 29 Nov, 2021 US8691847
Expire Patent 22 Nov, 2021 US8557852
Expire Patent 04 Oct, 2021 US8518977
Maintenance Fee Reminder Mailed 07 Jun, 2021 US8557852
Expire Patent 31 May, 2021 US9629831
Expire Patent 03 May, 2021 US8404724
Maintenance Fee Reminder Mailed 19 Apr, 2021 US8518977
Payment of Maintenance Fee, 12th Year, Large Entity 06 Apr, 2021 US7598276
Maintenance Fee Reminder Mailed 14 Dec, 2020 US9629831


FDA has granted several exclusivities to Bevyxxa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bevyxxa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Bevyxxa.

Exclusivity Information

Bevyxxa holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Bevyxxa's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jun 23, 2022

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Several oppositions have been filed on Bevyxxa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Bevyxxa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Bevyxxa patents.

Bevyxxa's Oppositions Filed in EPO

Bevyxxa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 18, 2013, by Zentiva K.S.. This opposition was filed on patent number EP07864488A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP07864488A Nov, 2013 Sölch, Günter Revoked
EP07864488A Nov, 2013 Zentiva k.s. Revoked


US patents provide insights into the exclusivity only within the United States, but Bevyxxa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Bevyxxa's family patents as well as insights into ongoing legal events on those patents.

Bevyxxa's Family Patents

Bevyxxa has patent protection in a total of 26 countries. It's US patent count contributes only to 23.3% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Bevyxxa.

Family Patents

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Generic Launch

Generic Release Date:

Bevyxxa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 29, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Bevyxxa Generics:

There are no approved generic versions for Bevyxxa as of now.

Alternative Brands for Bevyxxa

Bevyxxa which is used for preventing blood clots and thrombosis., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Bristol Myers Squibb
Eliquis Used for reducing the risk of stroke and systemic embolism.





About Bevyxxa

Bevyxxa is a drug owned by Portola Pharmaceuticals Inc. It is used for preventing blood clots and thrombosis. Bevyxxa uses Betrixaban as an active ingredient. Bevyxxa was launched by Portola Pharms Inc in 2017.

Approval Date:

Bevyxxa was approved by FDA for market use on 23 June, 2017.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Bevyxxa is 23 June, 2017, its NCE-1 date is estimated to be 23 June, 2021.

Active Ingredient:

Bevyxxa uses Betrixaban as the active ingredient. Check out other Drugs and Companies using Betrixaban ingredient

Treatment:

Bevyxxa is used for preventing blood clots and thrombosis.

Dosage:

Bevyxxa is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
80MG CAPSULE Discontinued ORAL
40MG CAPSULE Discontinued ORAL