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 days from now) | Active |
| US6835739 | Benzamides and related inhibitors of factor Xa |
Sep, 2020
(5 years ago) |
Expired
|
| US8691847 | Benzamides and related inhibitors of factor Xa |
Sep, 2020
(5 years ago) |
Expired
|
| US6376515 | Benzamides and related inhibitors of factor Xa |
Sep, 2020
(5 years ago) |
Expired
|
| US8518977 | Benzamides and related inhibitors of factor XA |
Sep, 2020
(5 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
(5 years from now) | Active |
| US8987463 | Methods of synthesizing factor Xa inhibitors |
Dec, 2030
(5 years from now) | Active |
| US8557852 | Methods of using crystalline forms of a salt of a factor Xa inhibitor |
Sep, 2028
(2 years from now) | Active |
| US9555023 | Pharmaceutical salts and polymorphs of a factor Xa inhibitor |
Nov, 2026
(1 year, 10 days from now) | Active |
| US9629831 | Benzamides and related inhibitors of factor XA |
Sep, 2020
(5 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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent
Critical | 16 May, 2022 | US8691847 |
| Maintenance Fee Reminder Mailed
Critical | 29 Nov, 2021 | US8691847 |
| Expire Patent
Critical | 22 Nov, 2021 | US8557852 |
| Expire Patent
Critical | 04 Oct, 2021 | US8518977 |
| Maintenance Fee Reminder Mailed
Critical | 07 Jun, 2021 | US8557852 |
| Expire Patent
Critical | 31 May, 2021 | US9629831 |
| Expire Patent
Critical | 03 May, 2021 | US8404724 |
| Maintenance Fee Reminder Mailed
Critical | 19 Apr, 2021 | US8518977 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Apr, 2021 | US7598276 |
| Maintenance Fee Reminder Mailed
Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |
| |||
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 |