Posluma is a drug owned by Blue Earth Diagnostics Ltd. It is protected by 5 US drug patents filed from 2023 to 2025 out of which none have expired yet. Posluma's patents will be open to challenges from 26 May, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 27, 2041. Details of Posluma'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. | |||
| US11413360 | Dual mode radiotracer and—therapeutics |
Nov, 2038
(13 years from now) | Active |
| US12357711 | NA |
Nov, 2038
(13 years from now) | Active |
| US12377176 | NA |
Nov, 2038
(13 years from now) | Active |
| US12390540 | NA |
Aug, 2038
(12 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12036290 | Pharmaceutical formulations |
Nov, 2041
(16 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 Posluma's patents.
Latest Legal Activities on Posluma's Patents
Given below is the list of recent legal activities going on the following patents of Posluma.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 10 Jul, 2023 | US11413360 |
| Email Notification
Critical | 23 Dec, 2022 | US11413360 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 23 Dec, 2022 | US11413360 |
| Correspondence Address Change
Critical | 19 Dec, 2022 | US11413360 |
| Patent Issue Date Used in PTA Calculation
Critical | 16 Aug, 2022 | US11413360 |
| Recordation of Patent Grant Mailed
Critical | 16 Aug, 2022 | US11413360 |
| Email Notification
Critical | 28 Jul, 2022 | US11413360 |
| Issue Notification Mailed
Critical | 27 Jul, 2022 | US11413360 |
| Mail Response to 312 Amendment (PTO-271)
Critical | 06 Jul, 2022 | US11413360 |
| Application Is Considered Ready for Issue
Critical | 06 Jul, 2022 | US11413360 |
FDA has granted several exclusivities to Posluma. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Posluma, 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
Posluma.
Exclusivity Information
Posluma holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Posluma's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 25, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Posluma 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 Posluma's family patents as well as insights into
ongoing legal events
on those patents.
Posluma's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Posluma's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 27, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Posluma Generics:
There are no approved generic versions for Posluma as of now.
About Posluma
Posluma is a drug owned by Blue Earth Diagnostics Ltd. It is used for imaging prostate cancer recurrence. Posluma uses Flotufolastat F-18 Gallium as an active ingredient. Posluma was launched by Blue Earth in 2023.
Approval Date:
Posluma was approved by FDA for market use on 25 May, 2023.
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 Posluma is 25 May, 2023, its NCE-1 date is estimated to be 26 May, 2027.
Active Ingredient:
Posluma uses Flotufolastat F-18 Gallium as the active ingredient. Check out other Drugs and Companies using Flotufolastat F-18 Gallium ingredient
Treatment:
Posluma is used for imaging prostate cancer recurrence.
Dosage:
Posluma is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25ML (8-158mCi/ML) | SOLUTION | Prescription | INTRAVENOUS |