Baxfendy is a drug owned by Astrazeneca Ab. It is protected by 1 US drug patent filed in 2026 out of which none have expired yet. Baxfendy's patents will be open to challenges from 15 May, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 04, 2033. Details of Baxfendy'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. | |||
| US9353081 | Bicyclic Dihydroquinoline-2-One Derivatives |
Feb, 2033
(6 years from now) | Active |
FDA has granted several exclusivities to Baxfendy. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Baxfendy, 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
Baxfendy.
Exclusivity Information
Baxfendy holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Baxfendy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 15, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Baxfendy 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 Baxfendy's family patents as well as insights into
ongoing legal events
on those patents.
Baxfendy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Baxfendy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 04, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Baxfendy Generics:
There are no approved generic versions for Baxfendy as of now.
About Baxfendy
Baxfendy is a drug owned by Astrazeneca Ab. Baxfendy uses Baxdrostat as an active ingredient. Baxfendy was launched by Astrazeneca in 2026.
Approval Date:
Baxfendy was approved by FDA for market use on 15 May, 2026.
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 Baxfendy is 15 May, 2026, its NCE-1 date is estimated to be 15 May, 2030.
Active Ingredient:
Baxfendy uses Baxdrostat as the active ingredient. Check out other Drugs and Companies using Baxdrostat ingredient
Dosage:
Baxfendy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |