Vizamyl is a drug owned by Ge Healthcare. It is protected by 5 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 3 have expired. Vizamyl's patents have been open to challenges since 25 October, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 16, 2028. Details of Vizamyl'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. | |||
| US7270800 | Thioflavin derivatives for use in antemortem diagnosis of Alzheimer's disease and in vivo imaging and prevention of amyloid deposition |
Sep, 2025
(8 months from now) | Active |
| US8236282 | Benzothiazole derivative compounds, compositions and uses |
May, 2024
(7 months ago) |
Expired
|
| US7351401 | Thioflavin derivatives for use in the antemortem diagnosis of Alzheimers disease and in vivo imaging and prevention of amyloid deposition |
Jan, 2023
(1 year, 11 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8916131 | Radiopharmaceutical composition |
Sep, 2028
(3 years from now) | Active |
| US8691185 | Benzothiazole derivative compounds, compositions and uses |
Jan, 2023
(1 year, 11 months ago) |
Expired
|
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 Vizamyl's patents.
Latest Legal Activities on Vizamyl's Patents
Given below is the list of recent legal activities going on the following patents of Vizamyl.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jan, 2024 | US8236282 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2022 | US8916131 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Sep, 2021 | US8691185 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Jan, 2020 | US8236282 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2019 | US7351401 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Mar, 2019 | US7270800 |
| Post Issue Communication - Certificate of Correction | 27 Nov, 2018 | US7270800 |
| Post Issue Communication - Certificate of Correction | 14 Nov, 2018 | US8236282 |
| Post Issue Communication - Certificate of Correction | 07 Nov, 2018 | US8691185 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jun, 2018 | US8916131 |
FDA has granted several exclusivities to Vizamyl. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vizamyl, 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 Vizamyl.
Exclusivity Information
Vizamyl holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Vizamyl's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 25, 2018 |
US patents provide insights into the exclusivity only within the United States, but Vizamyl 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 Vizamyl's family patents as well as insights into ongoing legal events on those patents.
Vizamyl's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vizamyl's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 16, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vizamyl Generics:
There are no approved generic versions for Vizamyl as of now.
Alternative Brands for Vizamyl
Vizamyl which is used for imaging internal structures and organs for diagnostic purposes., 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 | ||
|---|---|---|---|---|
| Lantheus Medcl |
| |||
About Vizamyl
Vizamyl is a drug owned by Ge Healthcare. It is used for imaging internal structures and organs for diagnostic purposes. Vizamyl uses Flutemetamol F-18 as an active ingredient. Vizamyl was launched by Ge Healthcare in 2013.
Approval Date:
Vizamyl was approved by FDA for market use on 25 October, 2013.
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 Vizamyl is 25 October, 2013, its NCE-1 date is estimated to be 25 October, 2017.
Active Ingredient:
Vizamyl uses Flutemetamol F-18 as the active ingredient. Check out other Drugs and Companies using Flutemetamol F-18 ingredient
Treatment:
Vizamyl is used for imaging internal structures and organs for diagnostic purposes.
Dosage:
Vizamyl is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 121.5mCi/30ML (4.05mCi/ML) | INJECTABLE | Prescription | INTRAVENOUS |
| 40.5mCi/10ML (4.05mCi/ML) | INJECTABLE | Discontinued | INTRAVENOUS |