Lymphoseek Kit is a drug owned by Cardinal Health 414 Llc Cardinal Health Nuclear Pharmacy Services. It is protected by 2 US drug patents filed from 2013 to 2016 out of which none have expired yet. Lymphoseek Kit's patents have been open to challenges since 13 March, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 30, 2029. Details of Lymphoseek Kit'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. | |||
| US6409990 | Macromolecular carrier for drug and diagnostic agent delivery |
May, 2025
(4 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9439985 | Compositions for radiolabeling diethylenetriaminepentaacetic acid (DTPA)-dextran |
Jan, 2029
(4 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 Lymphoseek Kit's patents.
Latest Legal Activities on Lymphoseek Kit's Patents
Given below is the list of recent legal activities going on the following patents of Lymphoseek Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Mar, 2020 | US9439985 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Jun, 2017 | US9439985 |
| Email Notification Critical | 05 Jun, 2017 | US9439985 |
| Correspondence Address Change Critical | 02 Jun, 2017 | US9439985 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 27 Mar, 2017 | US9439985 |
| Patent Issue Date Used in PTA Calculation Critical | 13 Sep, 2016 | US9439985 |
| Recordation of Patent Grant Mailed Critical | 13 Sep, 2016 | US9439985 |
| Email Notification Critical | 25 Aug, 2016 | US9439985 |
| Issue Notification Mailed Critical | 24 Aug, 2016 | US9439985 |
| Application Is Considered Ready for Issue Critical | 08 Aug, 2016 | US9439985 |
FDA has granted several exclusivities to Lymphoseek Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lymphoseek Kit, 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 Lymphoseek Kit.
Exclusivity Information
Lymphoseek Kit holds 5 exclusivities. All of its exclusivities have expired in 2024. Details of Lymphoseek Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-687) | Jun 13, 2017 |
| New Chemical Entity Exclusivity(NCE) | Mar 13, 2018 |
| Orphan Drug Exclusivity(ODE) | Jun 13, 2021 |
| Orphan Drug Exclusivity(ODE-67) | Jun 13, 2021 |
| New Patient Population(NPP) | May 19, 2024 |
US patents provide insights into the exclusivity only within the United States, but Lymphoseek Kit 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 Lymphoseek Kit's family patents as well as insights into ongoing legal events on those patents.
Lymphoseek Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lymphoseek Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 30, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lymphoseek Kit Generics:
There are no approved generic versions for Lymphoseek Kit as of now.
About Lymphoseek Kit
Lymphoseek Kit is a drug owned by Cardinal Health 414 Llc Cardinal Health Nuclear Pharmacy Services. Lymphoseek Kit uses Technetium Tc-99M Tilmanocept as an active ingredient. Lymphoseek Kit was launched by Cardinal Health 414 in 2013.
Approval Date:
Lymphoseek Kit was approved by FDA for market use on 13 March, 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 Lymphoseek Kit is 13 March, 2013, its NCE-1 date is estimated to be 13 March, 2017.
Active Ingredient:
Lymphoseek Kit uses Technetium Tc-99m Tilmanocept as the active ingredient. Check out other Drugs and Companies using Technetium Tc-99m Tilmanocept ingredient
Dosage:
Lymphoseek Kit is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| N/A | INJECTABLE | Prescription | INJECTION |