Neuraceq is a drug owned by Life Molecular Imaging Ltd. It is protected by 2 US drug patents filed in 2014 out of which none have expired yet. Neuraceq's patents have been open to challenges since 21 March, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 18, 2029. Details of Neuraceq'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. | |||
| US7907135 | Image display and image displaying method for gradation correction |
Mar, 2029
(3 years from now) | Active |
| US7807135 | Stilbene derivatives and their use for binding and imaging amyloid plaques |
Mar, 2029
(3 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 Neuraceq's patents.
Latest Legal Activities on Neuraceq's Patents
Given below is the list of recent legal activities going on the following patents of Neuraceq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Apr, 2022 | US7907135 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Apr, 2022 | US7807135 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Sep, 2018 | US7907135 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Apr, 2018 | US7807135 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Nov, 2012 | US7807135 |
| Correspondence Address Change Critical | 04 Nov, 2012 | US7807135 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Mar, 2011 | US7907135 |
| Recordation of Patent Grant Mailed Critical | 15 Mar, 2011 | US7907135 |
| Issue Notification Mailed Critical | 23 Feb, 2011 | US7907135 |
| Printer Rush- No mailing | 11 Feb, 2011 | US7907135 |
FDA has granted several exclusivities to Neuraceq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Neuraceq, 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 Neuraceq.
Exclusivity Information
Neuraceq holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Neuraceq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 21, 2019 |
US patents provide insights into the exclusivity only within the United States, but Neuraceq 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 Neuraceq's family patents as well as insights into ongoing legal events on those patents.
Neuraceq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Neuraceq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 18, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Neuraceq Generics:
There are no approved generic versions for Neuraceq as of now.
About Neuraceq
Neuraceq is a drug owned by Life Molecular Imaging Ltd. It is used for estimating p-amyloid neuritic plaque density in adult patients with cognitive impairment through PET imaging of the brain. Neuraceq uses Florbetaben F-18 as an active ingredient. Neuraceq was launched by Life Molecular in 2014.
Approval Date:
Neuraceq was approved by FDA for market use on 19 March, 2014.
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 Neuraceq is 19 March, 2014, its NCE-1 date is estimated to be 21 March, 2018.
Active Ingredient:
Neuraceq uses Florbetaben F-18 as the active ingredient. Check out other Drugs and Companies using Florbetaben F-18 ingredient
Treatment:
Neuraceq is used for estimating p-amyloid neuritic plaque density in adult patients with cognitive impairment through PET imaging of the brain.
Dosage:
Neuraceq is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.4-135mCi/ML | SOLUTION | Prescription | INTRAVENOUS |