Vizimpro is a drug owned by Pfizer Inc. It is protected by 4 US drug patents filed from 2018 to 2022 out of which none have expired yet. Vizimpro's patents have been open to challenges since 27 September, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 26, 2028. Details of Vizimpro'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. | |||
| US7772243 | 4-phenylamino-quinazolin-6-yl-amides |
Aug, 2028
(3 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). | |||
| US10603314 | Method for treating gefitinib resistant cancer |
Feb, 2026
(1 year, 2 months from now) | Active |
| US10596162 | Method for treating gefitinib resistant cancer |
Feb, 2026
(1 year, 2 months from now) | Active |
| US8623883 | 4-phenylamino-quinazolin-6-yl-amides |
May, 2025
(5 months 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 Vizimpro's patents.
Latest Legal Activities on Vizimpro's Patents
Given below is the list of recent legal activities going on the following patents of Vizimpro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 28 Dec, 2023 | US7772243 |
| transaction for FDA Determination of Regulatory Review Period | 08 Dec, 2023 | US7772243 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Sep, 2023 | US10603314 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Sep, 2023 | US10596162 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jan, 2022 | US7772243 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jun, 2021 | US8623883 |
| Second letter to regulating agency to determine regulatory review period | 27 May, 2021 | US7772243 |
| Sequence Moved to Public Database | 31 Mar, 2020 | US10603314 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Mar, 2020 | US10603314 |
| Recordation of Patent Grant Mailed Critical | 31 Mar, 2020 | US10603314 |
FDA has granted several exclusivities to Vizimpro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vizimpro, 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 Vizimpro.
Exclusivity Information
Vizimpro holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Vizimpro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 27, 2023 |
| Orphan Drug Exclusivity(ODE-206) | Sep 27, 2025 |
| Orphan Drug Exclusivity(ODE-213) | Sep 27, 2025 |
Several oppositions have been filed on Vizimpro's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Vizimpro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vizimpro patents.
Vizimpro's Oppositions Filed in EPO
Vizimpro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 28, 2011, by Boehringer Ingelheim International Gmbh. This opposition was filed on patent number EP06720163A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06720163A | Nov, 2011 | BOEHRINGER INGELHEIM INTERNATIONAL GMBH | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Vizimpro 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 Vizimpro's family patents as well as insights into ongoing legal events on those patents.
Vizimpro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vizimpro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 26, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vizimpro Generics:
There are no approved generic versions for Vizimpro as of now.
Alternative Brands for Vizimpro
Vizimpro which is used for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations., 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 | ||
|---|---|---|---|---|
| Osi Pharms |
| |||
About Vizimpro
Vizimpro is a drug owned by Pfizer Inc. It is used for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. Vizimpro uses Dacomitinib as an active ingredient. Vizimpro was launched by Pfizer in 2018.
Approval Date:
Vizimpro was approved by FDA for market use on 27 September, 2018.
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 Vizimpro is 27 September, 2018, its NCE-1 date is estimated to be 27 September, 2022.
Active Ingredient:
Vizimpro uses Dacomitinib as the active ingredient. Check out other Drugs and Companies using Dacomitinib ingredient
Treatment:
Vizimpro is used for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.
Dosage:
Vizimpro is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | TABLET | Prescription | ORAL |
| 30MG | TABLET | Prescription | ORAL |
| 45MG | TABLET | Prescription | ORAL |