USA — The patent dispute between Supernus and Sage Chemical over the Parkinson’s drug Apokyn has caught the attention of the Federal Trade Commission (FTC), which has expressed concerns over its potential impact on patients.
In a recent amicus brief, the FTC argued that the case may have “significant implications” for patients who rely on the drug.
Sage Chemical was granted the first generic approval for its Apokyn formulation in 2022, but the approval only pertained to the generic drug cartridges and not the injector pen required for administration.
Patients who wanted to take the generic version would need to obtain the brand-name Apokyn pen separately.
Sage and TruPharma have alleged that Supernus has unlawfully delayed or blocked generics to Apokyn, including through its control over the injector pen.
Supernus has filed a motion to dismiss the case, but the FTC has intervened, arguing that the legal issues in the case are of broader public interest.
The FTC emphasized that competition from cheaper generic versions of branded drugs saves consumers billions of dollars each year, and any delay or obstruction of generic drugs can harm patients and the healthcare system as a whole.
According to the FTC, Sage Chemical has made minimal sales of its Apokyn generic in the year since its approval, while patients continue to pay high prices for Apokyn due to an alleged anticompetitive scheme by Supernus.
The agency stated that the lack of generic drug competition typically harms consumers and competition.
In 2022, the brand-name Apokyn generated US$75.3 million in sales, a decrease of 24% from the previous year.
In 2020, Supernus acquired Apokyn, along with Myobloc and Xadago, as part of its US$300 million purchase of US WorldMeds’ CNS portfolio.
It’s worth noting that the market for Parkinson’s Disease (PD) therapy is expected to grow significantly in the coming years.
For instance, the global Parkinson’s disease treatment market is expected to expand at a compound annual growth rate (CAGR) of 12.1% from 2022 to 2030, indicating significant growth potential in this sector.
According to the International Parkinson and Movement Disorder Society, there were about 9.4 million individuals with PD worldwide in 2020, and this number is expected to increase in the coming years, particularly in the aging population.
PD affects around 1% of the total population over the age of 60 years, which rises to 5% for the population over the age of 85 years.
With the number of individuals aged 80 years and above projected to double by 2050, reaching more than 1.5 billion globally, the rise in the prevalence of PD is a cause for concern.
Given the statistics provided, it is evident that Parkinson’s Disease (PD) is a growing concern, particularly in the aging population.
In light of these statistics, there is a need for more generics for Parkinson’s Disease treatment. With the increasing burden of PD and the aging population, the demand for affordable and accessible treatments is likely to rise.
The development of more generics can help address this issue and improve the affordability and accessibility of PD treatment for all.
The high burden of PD in western countries, the increasing geriatric population, and the strong product pipeline of disease-modifying therapies are anticipated to be major drivers for the industry.
Furthermore, the availability of different dosage forms can enable product differentiation for pharmaceutical companies, resulting in greater profits.
NeuroDerm is one such company developing ND0612 for the treatment of patients with moderate-to-severe PD, for whom oral medications are no longer effective.
For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.
