Zegfrovy is a drug owned by Dizal (jiangsu) Pharmaceutical Co Ltd. It is protected by 3 US drug patents filed in 2025 out of which none have expired yet. Zegfrovy's patents will be open to challenges from 02 July, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 28, 2039. Details of Zegfrovy'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. | |||
| US11007198 | Erbb/Btk Inhibitors |
Jan, 2039
(12 years from now) | Active |
| US11896597 | Erbb/Btk Inhibitors |
Jan, 2039
(12 years from now) | Active |
| US11504375 | Erbb/Btk Inhibitors |
Jan, 2039
(12 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 Zegfrovy's patents.
Latest Legal Activities on Zegfrovy's Patents
Given below is the list of recent legal activities going on the following patents of Zegfrovy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Initial letter Re: PTE Application to regulating agency | 02 Sep, 2025 | US11007198 |
| Initial letter Re: PTE Application to regulating agency | 02 Sep, 2025 | US11504375 |
| Patent Term Extension Application under 35 USC 156 Filed | 27 Aug, 2025 | US11504375 |
| Patent Term Extension Application under 35 USC 156 Filed | 27 Aug, 2025 | US11007198 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Nov, 2024 | US11007198 |
| Mail Patent eGrant Notification | 13 Feb, 2024 | US11896597 |
| Patent Issue Date Used in PTA Calculation | 13 Feb, 2024 | US11896597 |
| Email Notification | 13 Feb, 2024 | US11896597 |
| Patent eGrant Notification | 13 Feb, 2024 | US11896597 |
| Recordation of Patent eGrant | 13 Feb, 2024 | US11896597 |
FDA has granted several exclusivities to Zegfrovy. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Zegfrovy, 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
Zegfrovy.
Exclusivity Information
Zegfrovy holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Zegfrovy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 02, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Zegfrovy 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 Zegfrovy's family patents as well as insights into
ongoing legal events
on those patents.
Zegfrovy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zegfrovy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 28, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zegfrovy Generics:
There are no approved generic versions for Zegfrovy as of now.
Alternative Brands for Zegfrovy
There are several other brand drugs in the same treatment category as Zegfrovy. 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 | ||
|---|---|---|---|---|
| Takeda Pharms Usa |
| |||
About Zegfrovy
Zegfrovy is a drug owned by Dizal (Jiangsu) Pharmaceutical Co Ltd. Zegfrovy uses Sunvozertinib as an active ingredient. Zegfrovy was launched by Dizal Jiangsu in 2025.
Approval Date:
Zegfrovy was approved by FDA for market use on 02 July, 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 Zegfrovy is 02 July, 2025, its NCE-1 date is estimated to be 02 July, 2029.
Active Ingredient:
Zegfrovy uses Sunvozertinib as the active ingredient. Check out other Drugs and Companies using Sunvozertinib ingredient
Dosage:
Zegfrovy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |