Prolonging Market Exclusivity of Brand-name Insulin

Examining FDA and patent records, researchers found that insulin manufacturers prolong market exclusivity for brand-name products.

Investigation into FDA and patent records unveils how insulin manufacturers secure prolonged market exclusivity through various tactics, including obtaining multiple patents on delivery devices as per a study led by William Feldman and colleagues, published in the open-access journal PLOS Medicine ().

Insulin is the primary, life-saving treatment for type 1 and some type 2 diabetes but remains costly in the US even though it was discovered more than a century ago.

Insulin Hormone
Insulin is a natural hormone that controls our blood sugar. Learn about types of insulin and devices for delivery including insulin syringes, pens and insulin pumps.

‘Insulin manufacturers have strategically prolonged market exclusivity for brand-name products over the last four decades, as revealed by an analysis of FDA and patent records. Tactics include filing additional patents post-FDA approval and acquiring numerous patents for insulin delivery devices. #insulin, #fda, #patent ’

A 2021 Congressional report found that for decades, the three major manufacturers of insulin continuously raised prices, often in tandem with one another.

These high prices are additionally sustained by patents and regulatory exclusivity that limit competition on brand-name products.

Patents are government-granted monopolies that last 20 years and the Food and Drug Administration (FDA) cannot approve generic versions of drugs for marketing until patents have expired.

Analyzing FDA and Patents Reveals Market Tactics

In the new study, researchers used publicly available U.S. FDA and patent data to track all insulin products approved in the U.S. from 1986 to 2019. During the study period, the FDA approved 56 brand-name insulin products.

Insulin Delivery Devices
Insulin delivery devices have evolved drastically since their invention in 1922. They are all aimed to provide insulin to the patients with minimal discomfort.

The researchers found that protection on insulin was enhanced by patents obtained after FDA approval, which lengthened expected market exclusivity by a median of 6 years.

Moreover, many patents were on the insulin delivery devices rather than the drugs themselves. In two-thirds of drug-device combinations, the device patents were the last to expire; these last-to-expire device patents extended protection for a median of 5.2 years.

Insulinoma
Insulinoma is a cancer of pancreas which causes excess release of insulin, thus leading to severe hypoglycemia.

Overall, manufacturers secured a median of 16 years of protection on their insulin products through patents and exclusivities, surpassing the median of 14 years observed in other studies of top-selling small-molecule drugs.

The insulin lines with the longest periods of expected protection from the first product approved to the last-to-expire patent were Lantus (32.9 years), followed by Novolog (32.3 years) and Novolog 70/30 (30.9 years).

Optimal Management of Basal-bolus Insulin Regimen
The main objective of going on a basal-bolus insulin regimen is to keep the blood sugar range as healthy as possible.

“Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have timely access to drugs at fair prices,” the authors say.

Feldman adds, “Our study highlights how manufacturers have listed an increasing number of patents on insulin products over the years. These patents can delay competition and keep prices high for patients.”

Reference:

Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019 - (https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004309)

Source-Eurekalert