Qalsody is a drug owned by Biogen Ma Inc. It is protected by 3 US drug patents filed in 2023 out of which none have expired yet. Qalsody's patents will be open to challenges from 26 April, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 01, 2035. Details of Qalsody'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. | |||
| US10385341 | Compositions for modulating SOD-1 expression |
Apr, 2035
(10 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). | |||
| US10968453 | Compositions for modulating SOD-1 expression |
Apr, 2035
(10 years from now) | Active |
| US10669546 | Compositions for modulating SOD-1 expression |
Apr, 2035
(10 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 Qalsody's patents.
Latest Legal Activities on Qalsody's Patents
Given below is the list of recent legal activities going on the following patents of Qalsody.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 22 May, 2024 | US10385341 |
| Second letter to regulating agency to determine regulatory review period | 22 May, 2024 | US10968453 |
| Second letter to regulating agency to determine regulatory review period | 22 May, 2024 | US10669546 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US10669546 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US10385341 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US10968453 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Feb, 2024 | US10669546 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Feb, 2024 | US10968453 |
| Email Notification Critical | 01 Feb, 2024 | US10669546 |
| Email Notification Critical | 01 Feb, 2024 | US10968453 |
FDA has granted several exclusivities to Qalsody. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qalsody, 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 Qalsody.
Exclusivity Information
Qalsody holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Qalsody's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 25, 2028 |
| Orphan Drug Exclusivity(ODE-432) | Apr 25, 2030 |
US patents provide insights into the exclusivity only within the United States, but Qalsody 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 Qalsody's family patents as well as insights into ongoing legal events on those patents.
Qalsody's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Qalsody's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 01, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qalsody Generics:
There are no approved generic versions for Qalsody as of now.
About Qalsody
Qalsody is a drug owned by Biogen Ma Inc. It is used for treating amyotrophic lateral sclerosis (ALS) in adult patients with a mutation in the SOD1 gene. Qalsody uses Tofersen as an active ingredient. Qalsody was launched by Biogen Ma in 2023.
Approval Date:
Qalsody was approved by FDA for market use on 25 April, 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 Qalsody is 25 April, 2023, its NCE-1 date is estimated to be 26 April, 2027.
Active Ingredient:
Qalsody uses Tofersen as the active ingredient. Check out other Drugs and Companies using Tofersen ingredient
Treatment:
Qalsody is used for treating amyotrophic lateral sclerosis (ALS) in adult patients with a mutation in the SOD1 gene.
Dosage:
Qalsody is available in solution form for intrathecal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/15ML (6.7MG/ML) | SOLUTION | Prescription | INTRATHECAL |