Ablavar is a drug owned by Lantheus Medical Imaging Inc. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Ablavar's patents have been open to challenges since 22 December, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be May 04, 2020. Details of Ablavar's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6676929 | Diagnostic imaging contrast agents with extended blood retention |
May, 2020
(5 years ago) |
Expired
|
| US8017105 | Diagnostic imaging contrast agents with extended blood retention |
May, 2015
(10 years ago) |
Expired
|
| US7229606 | Diagnostic imaging contrast agents with extended blood retention |
May, 2015
(10 years ago) |
Expired
|
| US7060250 | Diagnostic imaging contrast agents with extended blood retention |
May, 2015
(10 years ago) |
Expired
|
| US8394356 | Diagnostic imaging contrast agents with extended blood retention |
Feb, 2015
(10 years ago) |
Expired
|
| US7011815 | Diagnostic imaging contrast agents with extended blood retention |
Feb, 2015
(10 years 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 Ablavar's patents.
Latest Legal Activities on Ablavar's Patents
Given below is the list of recent legal activities going on the following patents of Ablavar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 15 Jul, 2019 | US7229606 |
| Maintenance Fee Reminder Mailed
Critical | 28 Jan, 2019 | US7229606 |
| Expire Patent
Critical | 09 Jul, 2018 | US7060250 |
| Expire Patent
Critical | 09 Apr, 2018 | US7011815 |
| Maintenance Fee Reminder Mailed
Critical | 22 Jan, 2018 | US7060250 |
| Maintenance Fee Reminder Mailed
Critical | 23 Oct, 2017 | US7011815 |
| Expire Patent
Critical | 07 Apr, 2017 | US8394356 |
| Expire Patent
Critical | 12 Oct, 2015 | US8017105 |
| Patent Issue Date Used in PTA Calculation
Critical | 12 Mar, 2013 | US8394356 |
| Recordation of Patent Grant Mailed
Critical | 12 Mar, 2013 | US8394356 |
FDA has granted several exclusivities to Ablavar. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Ablavar, 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
Ablavar.
Exclusivity Information
Ablavar holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Ablavar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 22, 2013 |
US patents provide insights into the exclusivity only within the United States, but
Ablavar 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 Ablavar's family patents as well as insights into
ongoing legal events
on those patents.
Ablavar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ablavar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 04, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ablavar Generics:
There are no approved generic versions for Ablavar as of now.
About Ablavar
Ablavar is a drug owned by Lantheus Medical Imaging Inc. It is used for imaging mammalian tissues using MRI technology. Ablavar uses Gadofosveset Trisodium as an active ingredient. Ablavar was launched by Lantheus Medcl in 2008.
Approval Date:
Ablavar was approved by FDA for market use on 22 December, 2008.
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 Ablavar is 22 December, 2008, its NCE-1 date is estimated to be 22 December, 2012.
Active Ingredient:
Ablavar uses Gadofosveset Trisodium as the active ingredient. Check out other Drugs and Companies using Gadofosveset Trisodium ingredient
Treatment:
Ablavar is used for imaging mammalian tissues using MRI technology.
Dosage:
Ablavar is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2440MG/10ML (244MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| 3660MG/15ML (244MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |