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. | |||
| US11504375 | NA |
Jan, 2039
(13 years from now) | Active |
| US11896597 | NA |
Jan, 2039
(13 years from now) | Active |
| US11007198 | NA |
Jan, 2039
(13 years from now) | Active |
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 |