Fensolvi Kit is a drug owned by Tolmar International Ltd. It is protected by 6 US drug patents filed from 2020 to 2025. Out of these, 3 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 22, 2041. Details of Fensolvi 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. | |||
| US11931559 | Systems and methods for mixing syringe valve assemblies |
Dec, 2041
(16 years from now) | Active |
| US11771841 | Systems and methods for mixing syringe valve assemblies |
Dec, 2041
(16 years from now) | Active |
| US8470359 | Sustained release polymer |
Oct, 2023
(2 years ago) |
Expired
|
| US9914802 | Sustained release polymer |
Nov, 2020
(4 years ago) |
Expired
|
| US9539333 | Sustained release polymer |
Nov, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12397120 | NA |
Dec, 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 Fensolvi Kit's patents.
Latest Legal Activities on Fensolvi Kit's Patents
Given below is the list of recent legal activities going on the following patents of Fensolvi Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA)
Critical | 24 Apr, 2024 | US11931559 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 24 Apr, 2024 | US11771841 |
| Email Notification
Critical | 24 Apr, 2024 | US11931559 |
| Email Notification
Critical | 24 Apr, 2024 | US11771841 |
| Recordation of Patent eGrant | 19 Mar, 2024 | US11931559 |
| Patent eGrant Notification | 19 Mar, 2024 | US11931559 |
| Mail Patent eGrant Notification | 19 Mar, 2024 | US11931559 |
| Patent Issue Date Used in PTA Calculation
Critical | 19 Mar, 2024 | US11931559 |
| Email Notification
Critical | 19 Mar, 2024 | US11931559 |
| Recordation of Patent Grant Mailed
Critical | 19 Mar, 2024 | US11931559 |
FDA has granted several exclusivities to Fensolvi Kit. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Fensolvi 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
Fensolvi Kit.
Exclusivity Information
Fensolvi Kit holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Fensolvi Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-829) | May 01, 2023 |
Several oppositions have been filed on Fensolvi Kit's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Fensolvi Kit's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Fensolvi Kit patents.
Fensolvi Kit's Oppositions Filed in EPO
Fensolvi Kit has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 23, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP09012462A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP09012462A | Oct, 2013 | Generics [UK] Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Fensolvi 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 Fensolvi Kit's family patents as well as insights into
ongoing legal events
on those patents.
Fensolvi Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fensolvi Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 22, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fensolvi Kit Generic API suppliers:
Leuprolide Acetate is the generic name for the brand Fensolvi Kit. 9 different companies have already filed for the generic of Fensolvi Kit, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fensolvi Kit's generic
Alternative Brands for Fensolvi Kit
Fensolvi Kit which is used for treating central precocious puberty in pediatric patients aged 2 years and older., has several other brand drugs in the same treatment category and using the same active ingredient (Leuprolide Acetate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Abbvie Endocrine Inc |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Leuprolide Acetate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie Endocrine |
| |
| Abbvie Endocrine Inc |
| |
| Invagen Pharms |
| |
| Ortho Mcneil Janssen |
| |
| Tolmar |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Leuprolide Acetate, Fensolvi Kit's active ingredient. Check the complete list of approved generic manufacturers for Fensolvi Kit
About Fensolvi Kit
Fensolvi Kit is a drug owned by Tolmar International Ltd. It is used for treating central precocious puberty in pediatric patients aged 2 years and older. Fensolvi Kit uses Leuprolide Acetate as an active ingredient. Fensolvi Kit was launched by Tolmar in 2020.
Approval Date:
Fensolvi Kit was approved by FDA for market use on 01 May, 2020.
Active Ingredient:
Fensolvi Kit uses Leuprolide Acetate as the active ingredient. Check out other Drugs and Companies using Leuprolide Acetate ingredient
Treatment:
Fensolvi Kit is used for treating central precocious puberty in pediatric patients aged 2 years and older.
Dosage:
Fensolvi Kit is available in powder form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 45MG | POWDER | Prescription | SUBCUTANEOUS |