Much to the delight of American women, oral contraceptives, known as “the pill,” will now be available without a prescription.
The U.S. Food and Drug Administration (FDA) approved the application for sale without a prescription of the Opill (norgestrel) brand on July 13. Perrigo, through its acquisition of HRA Pharma, is expected to launch the progestin-only, once-a-day oral medication in early 2024. While improved access to oral contraceptives makes interesting headlines, most women that want these products already access them for low- or no-cost copays through their health insurers, the Affordable Care Act, or groups such as Planned Parenthood. Therefore, demand for this new over-the-counter (OTC) brand is likely to come from women who do not utilize insurance and who have the means to afford the medication out-of-pocket. The pricing of the new brand will likely need to be relatively low compared to other switch brands in order to be on par with current prescription costs, assuming insurance coverage for oral contraceptives remains intact once the product is made available OTC.
Opill Norgestrel Tablets 0.075 mg
Also, in July 2023, Harm Reduction Therapeutics received approval to sell RiVive brand naloxone HCl 3mg nasal spray as an OTC medication. The product offers emergency treatment for opioid overdose, and this first-in-class switch is expected to have a favorable effect on reducing opioid overdose deaths by expanding access to the life-saving medication. In fact, the path toward approval of this drug is very unique because in November 2022, the FDA made the unprecedented move of actually developing a model for the Drug Facts Label and invited the pharmaceutical industry to complete an application. Harm Reduction Therapeutics is a nonprofit pharmaceutical company that is clear about its goal to provide OTC RiVive to the market for free or at the lowest possible cost.
RiVive Naloxone HCI Nasal Spray 3 mg
Since 2017, more than 290,000 Americans have died of opioid overdose, with about 48,000 deaths per year. Naloxone, commonly known as Narcan, has been available as a prescription drug since the 1970s, and it has been credited with saving tens of thousands of lives. Before being approved for OTC access, the product was distributed to emergency departments, local pharmacies via a doctor’s prescription, and through advocacy and community groups aimed at reducing opioid overdose/addiction. Now that it has gained OTC approval, it will be made available through retail pharmacies, convenience and food stores, and online to anyone who wants to have it on hand. The company recommends that friends and family of opioid users—as well as anyone who lives or works in an area where opioid misuse is common—to carry the product.
Narcan Naloxone HCI Nasal Spray 4 mg
Both of these switches were analyzed in-depth in Kline’s Rx-to-OTC Switch Forecasts: U.S. Market Analysis and Opportunities report. For over 35 years, Kline has been a trusted advisor to numerous consumer healthcare clients, providing support on switch assessments and forecasting through both syndicated switch reports and management consulting. Our Rx-to-OTC Switch Forecasting Model is a widely utilized tool that provides market forecasts rooted in deep industry expertise. For more information on how Kline’s switch consulting team can help your business, please contact us.