We recently wrote about the Hatch-Waxman Act and the negotiation that occurred to allow for longer patents for new drugs on the market. Now we dive into skinny labels, what they are, and how they may prevent brand-name drug manufacturers from delaying the competition. In this blog, we will share the skinny, on skinny labels.
Skinny labeling is when a generic drug company requests regulatory approval to market its medicine for a specific use, but not the patent uses that a brand-name drug may be prescribed for. For instance, a generic drug could be marketed to treat one kind of heart problem but not another which may be under patent by a brand-name drug company. You can see that this could get into a blurred territory and though skinny labeling is “explicitly permitted by statute”, there have been recent court decisions that have increased the risk for generic manufacturers of being stuck with claims of patent infringement. Under the Hatch-Waxman Amendments, drug companies can submit “an Abbreviated New Drug Application (ANDA)”, for generic versions of brand-name drugs. This process is easier and quicker because it uses the FDA’s existing effectiveness and safety of brand name drugs as long as the company shows that the generic version is “bioequivalent to the listed drug.”
“Skinny labeling can promote more timely availability of generic drugs and prevent delays in low-cost competition for brand-name products.” In a study that reviewed the first generic drug approvals between 2015-2019, the results identified that of the 56 brand-name drugs available as generic, 24 had generic formulations with skinny labels. It was also noted that the median time between skinny label approval and the expiration date of the patent was about 3.2 years.
The introduction of generic versions of popular and often vital drugs will continue and be beneficial to consumers. Brand-name drug companies will also continue to ensure that the drugs they develop receive the patents needed and the time to be in the market to recoup and benefit from R&D costs.
Pragmatyxs continues to train and stay informed of changes in the regulatory environment and pharmaceutical labeling compliance. We are ready to help companies ensure their labeling solution is providing the compliance their product and industry requirements.