Currently there are no generic Asthma/COPD inhalers available in the United States. This includes both categories of standard asthma treatment: rescue medication for quick relief and controller medications for long term prevention. The average cost of the above inhaler medicines ranges from $35 – $300, rendering the treatment expensive for both insured and uninsured consumers. At the same time, the opportunity is ripe for generic companies racing to be the first to market and to grab a slice of the 5 billion dollar pie.
As many pressurized metered dose inhalers (pMDIs) approach patent expiration, and with the lack of a guidance document from the US Food and Drug Administration (FDA), generic companies are reluctant to invest in product development which ultimately may not be acceptable to the Agency. In this white paper, Next Breath highlights key considerations and addresses strategies that are believed to reduce risk and ultimately speed up the process for getting a generic pMDI product to the US market. This white paper will focus on the key considerations and a stepwise approach that we believe are critical in managing the complexities and unknowns around the development of generic pMDIs.