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QALSODY Drug Patent Profile

When do Qalsody patents expire, and when can generic versions of Qalsody launch?

Qalsody is a drug marketed by Biogen Ma and is included in one NDA. There are three patents protecting this drug.

This drug has sixty patent family members in twenty-six countries.

The generic ingredient in QALSODY is tofersen. One supplier is listed for this compound. Additional details are available on the tofersen profile page.

DrugPatentWatch^® Generic Entry Outlook for Qalsody

Qalsody will be eligible for patent challenges on April 25, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 25, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for QALSODY

International Patents:	60
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for QALSODY
What excipients (inactive ingredients) are in QALSODY?	QALSODY excipients list
DailyMed Link:	QALSODY at DailyMed

See drug prices for QALSODY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QALSODY

Constraining patent/regulatory exclusivity:

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE

NDA:

215887

Dosage:

SOLUTION;INTRATHECAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for QALSODY

Drug Class

Antisense Oligonucleotide

US Patents and Regulatory Information for QALSODY

QALSODY is protected by three US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes			Y	Y
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes

International Patents for QALSODY

See the table below for patents covering QALSODY around the world.

Country	Patent Number	Title	Estimated Expiration
China	106459972	用于调节SOD‑1表达的组合物 (Compositions for modulating SOD-1 expression)
Mexico	2020007166	COMPOSICIONES PARA MODULAR LA EXPRESION DE SOD-1. (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION.)
Australia	2019268063
Canada	2942394	COMPOSITIONS MODULANT L'EXPRESSION DE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
South Korea	20220077933	SOD-1 발현을 조절하기 위한 조성물 (SOD-1 COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Serbia	63487	KOMPOZICIJE ZA MODULACIJU EKSPRESIJE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)

Supplementary Protection Certificates for QALSODY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3126499	301293	Netherlands		PRODUCT NAME: TOFERSEN; REGISTRATION NO/DATE: EU/1/23/1783 20240603
3126499	CR 2024 00038	Denmark		PRODUCT NAME: TOFERSEN; REG. NO/DATE: EU/1/23/1783 20240603

QALSODY Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Qalsody

Introduction to Qalsody

Qalsody, formerly known as tofersen, is a groundbreaking drug developed by Biogen in collaboration with Ionis Pharmaceuticals to treat amyotrophic lateral sclerosis (ALS) in patients with a mutation in the superoxide dismutase 1 (SOD1) gene. Here, we delve into the market dynamics and financial trajectory of this innovative therapy.

Regulatory Approvals and Recommendations

Qalsody has received significant regulatory milestones that have paved the way for its market entry. In April 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Qalsody to treat ALS patients with the SOD1 mutation, based on its ability to reduce neurofilament light chain (NfL) levels, a marker of neurodegeneration[3][4].

Additionally, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Qalsody, with the final decision on marketing authorization expected in Q2 of 2024[1].

Clinical Trials and Efficacy

The approval of Qalsody was largely based on data from the Phase III VALOR trial and the open-label extension study. Although Qalsody missed the primary efficacy endpoint of ALS function measured using the Revised ALS Functional Rating Scale (ALSFRS-R), it met secondary endpoints by reducing neurofilament (NfL) and SOD1 protein levels. The 2022 VALOR open-label extension study showed a 35% reduction in SOD1 levels in cerebrospinal fluid compared to a 2% reduction with placebo[1][5].

Market Size and Growth Projections

The ALS market is expected to grow significantly, driven by innovative therapies like Qalsody. The global ALS market size was valued at USD 494.1 million in 2023 and is projected to reach USD 715.4 million by 2034, with a compound annual growth rate (CAGR) of 3.4% during 2024-2034. This growth is fueled by increased research funding, collaboration between academic institutions and biotech firms, and the development of gene therapies and targeted biologics[3].

Financial Performance and Projections

Qalsody has already shown promising financial performance. In Q4 2023, the drug generated $3.3 million in US sales, according to Biogen's financial reports. GlobalData expects Qalsody to maintain an upward growth trajectory, projecting global sales to reach $128 million by 2029[1].

Pricing and Cost Considerations

The pricing of Qalsody is a critical factor in its market dynamics. Each vial of Qalsody costs $14,230, which translates to an annual cost of $199,200 for the recommended 14 doses per year. This makes Qalsody more expensive than other ALS treatments like Amylyx’s Relyvrio and Mitsubishi Tanabe’s edaravone[4].

Coverage and Access

Access to Qalsody has been a point of focus, particularly for patients on Medicare. The Centers for Medicare and Medicaid Services (CMS) has directed all Medicare Advantage plans to cover Qalsody for treating SOD1-ALS patients, ordering insurers to stop classifying the drug as “experimental and investigational”[5].

Real-World Impact

Qalsody has made a significant real-world impact on patients with SOD1-ALS. Real-world data supports the trial findings, showing some patients achieving stable disease or gains in motor function and life quality with Qalsody. Personal stories, such as that of Blaine Dangel, highlight the drug's positive impact on patients' lives[2].

Competitive Landscape

The ALS treatment market is becoming increasingly competitive with several drugs and therapies in development. Qalsody competes with other approved treatments like Amylyx’s Relyvrio (AMX0035) and Mitsubishi Tanabe’s edaravone. The competitive landscape is driven by the need for effective treatments for this devastating neurodegenerative disease[3][4].

Future Outlook

The future outlook for Qalsody is promising, given its regulatory approvals, clinical efficacy, and growing market demand. Biogen is required to conduct additional trials, including a study on presymptomatic ALS patients, to confirm the long-term efficacy of Qalsody. These trials will be crucial in solidifying Qalsody's position in the ALS treatment market[1][4].

Key Takeaways

• Regulatory Approvals: Qalsody has received FDA accelerated approval and a positive CHMP recommendation from the EMA.
• Clinical Efficacy: Qalsody reduces SOD1 and NfL levels, although it missed the primary efficacy endpoint in the VALOR trial.
• Market Growth: The ALS market is projected to grow to USD 715.4 million by 2034, driven by innovative therapies.
• Financial Projections: Qalsody is expected to reach $128 million in global sales by 2029.
• Pricing and Access: Qalsody is priced at $14,230 per vial, with Medicare Advantage plans directed to cover the treatment.
• Real-World Impact: Qalsody has shown positive real-world outcomes for patients with SOD1-ALS.

FAQs

Q: What is Qalsody and how does it work? A: Qalsody is an antisense oligonucleotide that inhibits the production of mutant superoxide dismutase 1 (SOD1) protein, which is linked to toxic effects on motor neurons in ALS patients.

Q: What are the key regulatory milestones for Qalsody? A: Qalsody received FDA accelerated approval in April 2023 and a positive CHMP recommendation from the EMA in 2024.

Q: How much does Qalsody cost? A: Each vial of Qalsody costs $14,230, translating to an annual cost of $199,200 for 14 doses.

Q: Is Qalsody covered by Medicare Advantage plans? A: Yes, the CMS has directed all Medicare Advantage plans to cover Qalsody for treating SOD1-ALS patients.

Q: What are the projected sales for Qalsody? A: GlobalData expects Qalsody to reach $128 million in global sales by 2029.

Sources

1. Pharmaceutical Technology: "Biogen receives EMA CHMP recommendation for ALS drug Qalsody"
2. MDA's Quest magazine: "Behind the Drug: Tofersen (Qalsody) for ALS"
3. BioSpace: "Amyotrophic Lateral Sclerosis (ALS) Market Size to Reach USD 715.4 Million by 2034"
4. BioSpace: "FDA Approves Biogen and Ionis' Qalsody as Fourth-Ever ALS Therapy"
5. ALS News Today: "Medicare Advantage plans in US told to cover Qalsody for SOD1-ALS"