Hyrnuo is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2025 out of which none have expired yet. Hyrnuo's patents will be open to challenges from 19 November, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 25, 2036. Details of Hyrnuo'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. | |||
| US10428063 | NA |
Jan, 2036
(10 years from now) | Active |
FDA has granted several exclusivities to Hyrnuo. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Hyrnuo, 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
Hyrnuo.
Exclusivity Information
Hyrnuo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Hyrnuo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 19, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Hyrnuo 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 Hyrnuo's family patents as well as insights into
ongoing legal events
on those patents.
Hyrnuo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Hyrnuo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 25, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hyrnuo Generics:
There are no approved generic versions for Hyrnuo as of now.
About Hyrnuo
Hyrnuo is a drug owned by Bayer Healthcare Pharmaceuticals Inc. Hyrnuo uses Sevabertinib as an active ingredient. Hyrnuo was launched by Bayer Healthcare in 2025.
Approval Date:
Hyrnuo was approved by FDA for market use on 19 November, 2025.
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 Hyrnuo is 19 November, 2025, its NCE-1 date is estimated to be 19 November, 2029.
Active Ingredient:
Hyrnuo uses Sevabertinib as the active ingredient. Check out other Drugs and Companies using Sevabertinib ingredient
Dosage:
Hyrnuo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |