Game On: FTC Greenlights Generic Competition for Ozempic

The Federal Trade Commission (FTC) is on a mission to pave the way for more affordable generic versions of the popular weight loss drug Ozempic. However, the journey towards having cheaper alternatives of this injectable diabetes treatment available for consumers is expected to be a lengthy and challenging one. The FTC recently issued a warning letter to various drug manufacturers, including the Denmark-based Novo Nordisk, the creator of Ozempic, signaling its intention to challenge what it refers to as “junk patents” that artificially maintain high medication prices.

Ozempic has garnered attention for its effectiveness in aiding weight loss and even demonstrating potential in slowing the advancement of kidney disease. The implications of a more cost-effective version of this drug could be significant for individuals seeking treatment options. To achieve this goal, the FTC is taking a stance against what it deems as the improper listing of patents in the Food and Drug Administration’s “Orange Book.” This listing outlines the patents associated with different brand-name drugs.

The FTC’s initiative comes in response to the practice by pharmaceutical companies of including excessive patents in the Orange Book, ranging from intellectual property rights to manufacturing processes. This strategic move is often employed to impede the production of generic versions of drugs. A recent investigation revealed that the top-selling medications in the United States held an average of 74 patents per drug, with some even having hundreds of what the FTC terms as “junk patents.”

Generic drug manufacturers have the option to challenge these excessive patents. However, brand-name drug companies can choose to contest these challenges in court, a move that can delay the approval of generic drugs by up to 30 months. FTC Chair Lina Khan emphasized the detrimental impact of these tactics on the affordability of prescription drugs for Americans. By addressing what she refers to as “bogus patent listings,” the FTC aims to combat these unlawful practices and ensure timely access to innovative and affordable medication options.

In addition to Novo Nordisk, the FTC has directed its attention towards other pharmaceutical companies, including AstraZeneca and the manufacturers of the Baqsimi nasal spray, among others. These companies have a 30-day window to rectify their patent listings, withdraw them, or provide testimony ensuring compliance with regulations prohibiting the inclusion of extraneous patents. The FTC’s campaign against “junk patents” marks a pivotal step towards creating a more competitive pharmaceutical landscape and improving accessibility to crucial medications for consumers in need.