Tag: Market exclusivity

Affecting an estimated one in ten Americans, there are more than 7,000 rare diseases, and for these patients, an orphan drug provides a critical, often life-saving, treatment option. Historically, the small patient populations for these conditions made drug development financially unviable, leading to a significant gap in treatment options.

Over 7,000 rare diseases collectively affect more than 30 million Americans, yet historically, most have had no approved treatment. Orphan drugs are specialized medications developed to treat, prevent, or diagnose these rare conditions, addressing a critical, unmet medical need.

According to a 2020 study, 108 branded drugs approved between 1983 and 2017 in the U.S. had multiple orphan indications, demonstrating that a drug can have multiple orphan drug designations. This practice of pursuing multiple indications for the same drug has significant implications for patients, pharmaceutical companies, and the broader healthcare system.

A 2024 study in *JAMA* estimated the median cost of bringing a new drug to market at nearly $1 billion, and for biologic drugs like Bimzelx, this figure can be even higher, contributing significantly to its expensive price. The high price tag of specialized medications is a significant barrier for many patients, prompting the question, 'Why is Bimzelx so expensive?'

With a history tracing back to 1500 BC, colchicine is one of the oldest medicines still in use [1.8.3]. So, was colchicine taken off the market? The answer is complex: unapproved versions were, but FDA-approved forms remain available.

With a wholesale acquisition cost of approximately $47,400 per year, Rezdiffra's price point has drawn significant attention. The question 'Why is Rezdiffra so expensive?' is answered by several factors, including its status as the first-in-class treatment for MASH, extensive research and development costs, and market exclusivity.

As of late 2024, the list price for a box of Nayzilam containing two doses was around $667, depending on the source. Many people wonder **why is Nayzilam so expensive?**, especially when the active ingredient, midazolam, is available in much cheaper generic forms. Several complex factors contribute to this high cost, primarily tied to its status as a novel, brand-name drug with market exclusivity.