Amyvid is a drug owned by Avid Radiopharmaceuticals Inc. It is protected by 2 US drug patents filed in 2013 out of which none have expired yet. Amyvid's patents have been open to challenges since 06 April, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 30, 2027. Details of Amyvid'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. | |||
| US8506929 | Styrylpyridine derivatives and their use for binding and imaging amyloid plaques |
Apr, 2027
(2 years from now) | Active |
| US7687052 | Styrylpyridine derivatives and their use for binding and imaging amyloid plaques |
Apr, 2027
(2 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 Amyvid's patents.
Latest Legal Activities on Amyvid's Patents
Given below is the list of recent legal activities going on the following patents of Amyvid.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Sep, 2021 | US7687052 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Feb, 2021 | US8506929 |
| Post Issue Communication - Certificate of Correction | 05 Jul, 2019 | US7687052 (Litigated) |
| Post Issue Communication - Certificate of Correction | 02 Jul, 2019 | US8506929 |
| Post Issue Communication - Certificate of Correction | 25 Mar, 2019 | US8506929 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Oct, 2017 | US7687052 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 13 Aug, 2013 | US8506929 |
| Recordation of Patent Grant Mailed Critical | 13 Aug, 2013 | US8506929 |
| Email Notification Critical | 25 Jul, 2013 | US8506929 |
| Issue Notification Mailed Critical | 24 Jul, 2013 | US8506929 |
FDA has granted several exclusivities to Amyvid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Amyvid, 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 Amyvid.
Exclusivity Information
Amyvid holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Amyvid's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 06, 2017 |
US patents provide insights into the exclusivity only within the United States, but Amyvid 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 Amyvid's family patents as well as insights into ongoing legal events on those patents.
Amyvid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Amyvid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 30, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Amyvid Generics:
There are no approved generic versions for Amyvid as of now.
About Amyvid
Amyvid is a drug owned by Avid Radiopharmaceuticals Inc. It is used for estimating beta-amyloid neuritic plaque density in adult patients with cognitive impairment. Amyvid uses Florbetapir F-18 as an active ingredient. Amyvid was launched by Avid Radiopharms Inc in 2012.
Approval Date:
Amyvid was approved by FDA for market use on 06 April, 2012.
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 Amyvid is 06 April, 2012, its NCE-1 date is estimated to be 06 April, 2016.
Active Ingredient:
Amyvid uses Florbetapir F-18 as the active ingredient. Check out other Drugs and Companies using Florbetapir F-18 ingredient
Treatment:
Amyvid is used for estimating beta-amyloid neuritic plaque density in adult patients with cognitive impairment.
Dosage:
Amyvid is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10ML (13.5-51mCi/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| 10-30ML (13.5-51mCi/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| 10-50ML (13.5-51mCi/ML) | SOLUTION | Prescription | INTRAVENOUS |