Brenzavvy is a drug owned by Theracosbio Llc. It is protected by 6 US drug patents filed in 2023 out of which none have expired yet. Brenzavvy's patents will be open to challenges from 20 January, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be May 14, 2032. Details of Brenzavvy'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. | |||
| US8987323 | Crystalline form of benzylbenzene SGLT2 inhibitor |
May, 2032
(6 years from now) | Active |
| US10981942 | Crystalline form of benzylbenzene SGLT2 inhibitor |
Jun, 2031
(5 years from now) | Active |
| US7838499 | Benzylbenzene derivatives and methods of use |
Jan, 2029
(3 years from now) | Active |
| US8802637 | Benzylbenzene derivatives and methods of use |
Aug, 2028
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10533032 | Crystalline form of benzylbenzene SGLT2 inhibitor |
Jul, 2031
(5 years from now) | Active |
| US8106021 | Benzylbenzene derivatives and methods of use |
Aug, 2028
(2 years from now) | Active |
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 Brenzavvy's patents.
Latest Legal Activities on Brenzavvy's Patents
Given below is the list of recent legal activities going on the following patents of Brenzavvy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification
Critical | 18 Dec, 2023 | US10533032 |
| Mail O.P. Petition Decision | 18 Dec, 2023 | US10533032 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 14 Dec, 2023 | US10533032 |
| Record Petition Decision of Granted to Make Entity Status large | 13 Dec, 2023 | US10533032 |
| O.P. Petition Decision | 10 Dec, 2023 | US10533032 |
| Email Notification
Critical | 30 Nov, 2023 | US8106021 |
| Mail O.P. Petition Decision | 30 Nov, 2023 | US8106021 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 28 Nov, 2023 | US8106021 |
| Record Petition Decision of Granted to Make Entity Status large | 27 Nov, 2023 | US8106021 |
| O.P. Petition Decision | 25 Nov, 2023 | US8106021 |
FDA has granted several exclusivities to Brenzavvy. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Brenzavvy, 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
Brenzavvy.
Exclusivity Information
Brenzavvy holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Brenzavvy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 20, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Brenzavvy 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 Brenzavvy's family patents as well as insights into
ongoing legal events
on those patents.
Brenzavvy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Brenzavvy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 14, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Brenzavvy Generics:
There are no approved generic versions for Brenzavvy as of now.
Alternative Brands for Brenzavvy
Brenzavvy which is used for improving glycemic control in adults with type 2 diabetes., 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 | ||||||
|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck |
| |||||||
About Brenzavvy
Brenzavvy is a drug owned by Theracosbio Llc. It is used for improving glycemic control in adults with type 2 diabetes. Brenzavvy uses Bexagliflozin as an active ingredient. Brenzavvy was launched by Theracosbio in 2023.
Approval Date:
Brenzavvy was approved by FDA for market use on 20 January, 2023.
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 Brenzavvy is 20 January, 2023, its NCE-1 date is estimated to be 20 January, 2027.
Active Ingredient:
Brenzavvy uses Bexagliflozin as the active ingredient. Check out other Drugs and Companies using Bexagliflozin ingredient
Treatment:
Brenzavvy is used for improving glycemic control in adults with type 2 diabetes.
Dosage:
Brenzavvy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET | Prescription | ORAL |