Koselugo is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 8 US drug patents filed from 2020 to 2025 out of which none have expired yet. Koselugo's patents have been open to challenges since 10 April, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 26, 2029. Details of Koselugo'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. | |||
| US9562017 | Hydrogen sulfate salt |
Dec, 2026
(1 year, 1 month from now) | Active |
| US9156795 | Hydrogen sulfate salt |
Dec, 2026
(1 year, 1 month from now) | Active |
| US7425637 | N3 alkylated benzimidazole derivatives as MEK inhibitors |
Mar, 2026
(4 months from now) | Active |
| US8178693 | N3 alkylated benzimidazole derivatives as MEK inhibitors |
Mar, 2026
(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). | |||
| US11813246 | Pharmaceutical composition |
Mar, 2029
(3 years from now) | Active |
| US12318367 | Pharmaceutical composition |
Mar, 2029
(3 years from now) | Active |
| US12220403 | Pharmaceutical composition |
Mar, 2029
(3 years from now) | Active |
| US12364684 | NA |
Mar, 2029
(3 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 Koselugo's patents.
Latest Legal Activities on Koselugo's Patents
Given below is the list of recent legal activities going on the following patents of Koselugo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jul, 2024 | US9562017 |
| Petition to Accept Late Payment of Maintenance Fee Payment Filed
Critical | 24 Jun, 2024 | US8178693 |
| Expire Patent
Critical | 17 Jun, 2024 | US8178693 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9156795 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US7425637 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US8178693 |
| Withdrawal of Application for PTE
Critical | 25 Jan, 2024 | US8178693 |
| Maintenance Fee Reminder Mailed
Critical | 01 Jan, 2024 | US8178693 |
| Interim Patent Term Extension Granted
Critical | 18 Dec, 2023 | US8178693 |
| Interim Patent Term Extension Granted
Critical | 18 Dec, 2023 | US7425637 |
FDA has granted several exclusivities to Koselugo. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Koselugo, 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
Koselugo.
Exclusivity Information
Koselugo holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Koselugo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 10, 2025 |
| Orphan Drug Exclusivity(ODE-288) | Apr 10, 2027 |
Several oppositions have been filed on Koselugo'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 Koselugo's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Koselugo patents.
Koselugo's Oppositions Filed in EPO
Koselugo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 19, 2018, by Generics [Uk] Limited (Trading As Mylan). This opposition was filed on patent number EP15177189A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15177189A | Apr, 2018 | Generics [UK] Limited (trading as Mylan) | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Koselugo 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 Koselugo's family patents as well as insights into
ongoing legal events
on those patents.
Koselugo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Koselugo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 26, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Koselugo Generics:
There are no approved generic versions for Koselugo as of now.
About Koselugo
Koselugo is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating symptomatic, inoperable plexiform neurofibromas in pediatric patients with neurofibromatosis type 1 (NF1) aged 2 years and older. Koselugo uses Selumetinib Sulfate as an active ingredient. Koselugo was launched by Astrazeneca in 2020.
Approval Date:
Koselugo was approved by FDA for market use on 10 April, 2020.
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 Koselugo is 10 April, 2020, its NCE-1 date is estimated to be 10 April, 2024.
Active Ingredient:
Koselugo uses Selumetinib Sulfate as the active ingredient. Check out other Drugs and Companies using Selumetinib Sulfate ingredient
Treatment:
Koselugo is used for treating symptomatic, inoperable plexiform neurofibromas in pediatric patients with neurofibromatosis type 1 (NF1) aged 2 years and older.
Dosage:
Koselugo is available in the following dosage forms - granule form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE | CAPSULE | Prescription | ORAL |
| EQ 10MG BASE | CAPSULE | Prescription | ORAL |
| EQ 5MG BASE | GRANULE | Prescription | ORAL |
| EQ 7.5MG BASE | GRANULE | Prescription | ORAL |