Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986-2020

Abstract

Inhalers are the mainstay of treatment for asthma and chronic obstructive pulmonary disease (COPD). These products face limited generic competition in the US and remain expensive. To better understand the strategies that brand-name inhaler manufacturers have employed to preserve their market dominance, we analyzed all patents and regulatory exclusivities granted to inhalers approved by the Food and Drug Administration between 1986 and 2020. Of the sixty-two inhalers approved, fifty-three were brand-name products, and these brand-name products had a median of sixteen years of protection from generic competition. Only one inhaler contained an ingredient with a new mechanism of action. More than half of all patents were on the inhaler devices, not the active ingredients or other aspects of these drug-device combinations. Manufacturers augmented periods of brand-name market exclusivity by moving active ingredients from one inhaler device into another ("device hops"). The median time from approval of an originator product to the last-to-expire patent or regulatory exclusivity of branded follow-ons was twenty-eight years (across device hops on fourteen originator products). Regulatory and patent reform is critical to ensure that the rewards bestowed on brand-name inhaler manufacturers better reflect the added clinical benefit of new products.

Exhibit 2:. Patents per inhaler at FDA approval, 1986-2020

Source: FDA Orange Book, Drugs@FDA, authors’ analysis This figure includes patents granted to inhalers that were filed prior to FDA approval. The median number of pre-approval patents grew from 2 per inhaler (interquartile range [IQR] 1-5) from 1986-1997 to 9 per inhaler (IQR 6-12) from 1998-2008 and 12 per inhaler (IQR 6.5-19.5) from 2009-2020.

Exhibit 3:. Device hops by inhaler manufacturers

Source: FDA Orange Book, Drugs@FDA, authors’ analysis GSK: GlaxoSmithKline *Denotes an inhaler containing chlorofluorocarbons (CFCs), which were removed from the market by the Food and Drug Administration beginning in the 2000s. This figure shows how manufacturers have preserved monopolies on inhaled medications by pairing old active ingredients with new devices. The notched dark blue bars represent the time that elapsed between the first patents filed for an originator product and FDA approval of that product. The solid dark blue bars represent the time that elapsed between FDA approval of an originator product and the last-to-expire exclusivity or patent on the originator or follow-on products. This reflects the total protection that a manufacturer has obtained on inhalers with a given active ingredient (or ingredients). The notched grey bars represent the time that elapsed between the first patents filings for a given product and FDA approval of that product. The solid grey bars represent the time that elapsed between FDA approval of a given product and the last-to-expire exclusivity or patent on that product. A median of 40.3 years (IQR 33.9-45.8) elapsed between the first patent filed on originator inhalers and the last-to-expire exclusivity or patent on these inhalers or their follow-ons. Manufacturers enjoyed a median of 28.1 years (IQR 21.3-33.5) of protection on these inhalers after FDA approval of the originator.

Exhibit 4:. Device hops by inhaler manufacturers

Source: FDA Orange Book, Drugs@FDA, authors’ analysis GSK: GlaxoSmithKline *Denotes an inhaler containing chlorofluorocarbons (CFCs), which were removed from the market by the Food and Drug Administration beginning in the 2000s. This figure shows how manufacturers have preserved monopolies on inhaled medications by pairing old active ingredients with new devices. The notched dark blue bars represent the time that elapsed between the first patents filed for an originator product and FDA approval of that product. The solid dark blue bars represent the time that elapsed between FDA approval of an originator product and the last-to-expire exclusivity or patent on the originator or follow-on products. This reflects the total protection that a manufacturer has obtained on inhalers with a given active ingredient (or ingredients). The notched grey bars represent the time that elapsed between the first patents filings for a given product and FDA approval of that product. The solid grey bars represent the time that elapsed between FDA approval of a given product and the last-to-expire exclusivity or patent on that product. A median of 40.3 years (IQR 33.9-45.8) elapsed between the first patent filed on originator inhalers and the last-to-expire exclusivity or patent on these inhalers or their follow-ons. Manufacturers enjoyed a median of 28.1 years (IQR 21.3-33.5) of protection on these inhalers after FDA approval of the originator.