Tofersen Patent Expiration
Tofersen is Used for treating amyotrophic lateral sclerosis (ALS) in adult patients with a mutation in the SOD1 gene. It was first introduced by Biogen Ma Inc
Tofersen Patents
Given below is the list of patents protecting Tofersen, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Qalsody | US10385341 | Compositions for modulating SOD-1 expression | Apr 01, 2035 | Biogen Ma |
| Qalsody | US10669546 | Compositions for modulating SOD-1 expression | Apr 01, 2035 | Biogen Ma |
| Qalsody | US10968453 | Compositions for modulating SOD-1 expression | Apr 01, 2035 | Biogen Ma |
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 Tofersen's patents.
Latest Legal Activities on Tofersen's Patents
Given below is the list recent legal activities going on the following patents of Tofersen.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Information Disclosure Statement (IDS) Filed | 20 Jun, 2025 | US10385341 |
| transaction for FDA Determination of Regulatory Review Period | 20 Jun, 2025 | US10669546 |
| transaction for FDA Determination of Regulatory Review Period | 20 Jun, 2025 | US10968453 |
| transaction for FDA Determination of Regulatory Review Period | 20 Jun, 2025 | US10385341 |
| Information Disclosure Statement (IDS) Filed | 20 Jun, 2025 | US10669546 |
| Information Disclosure Statement (IDS) Filed | 20 Jun, 2025 | US10968453 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Sep, 2024 | US10968453 |
| 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 | US10669546 |
| Second letter to regulating agency to determine regulatory review period | 22 May, 2024 | US10968453 |
Tofersen's Family Patents
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Clinical Trials
Recent Clinical Trials on Tofersen:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Tofersen in Non-SOD1 ALS | Washington University School of Medicine | NA |
RECRUITING
(Jun 1, 2026)
| PHASE2 |
| A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | Biogen | NA |
ACTIVE NOT RECRUITING
(Mar 1, 2026)
| PHASE3 |