Signal: Abortion pill restriction may drive more patients to off-label drug

As restrictions on abortion drug mifepristone loom, doctors and patients are looking to off-label misoprostol.

Isaac Hanson August 18 2023

The Wednesday (16 August) announcement that a US appeals court upheld restrictions on abortion pill mifepristone is likely to increase sales of its counterpart, misoprostol.

The US appeals court of the Fifth Circuit, which hears cases from district courts in Mississippi, Louisiana and Texas, has ruled that the drug can remain on the market, but that REMS changes made in 2016, which increased availability and almost doubled the time after pregnancy that the drug, could be taken must be reversed.

The legality of this decision has already been challenged both by the Department of Justice (DOJ) and many scientists and news outlets. The implementation of the decision is pending a supreme court review, but worries about the availability of the drug continue to increase.

GlobalData’s social media analysis of select industry leaders suggests that there was a sharp uptick in posts about abortion on Wednesday, but that net sentiment on the issue was at 0.03, meaning 97% of posts had a negative outlook. There is some hope in an alternative to the drug, however.

Reuters reported in April that an increasing number of women were using misoprostol as a one-pill abortion treatment. The two drugs are currently taken in combination, with mifepristone taken first and then followed around 24 hours later by misoprostol.

Although misoprostol is not officially licensed for induced abortion on its own in the United States, it is in many other countries, including India, the UK and Australia, and the efficacy is only slightly lower than taking it alongside mifepristone. When taken in the US it is prescribed off-label at a doctor’s digression, though it can then be ordered through an online pharmacy.

Reuters’ prediction that sales would continue to increase has proven true: ANI Pharmaceuticals, one of the key producers of generic misoprostol, has reported a 27% increase in generics revenue in Q2 2023 and named misoprostol as one of the key sales drivers according to GlobalData’s filing analytics.

As the drug has a wide range of uses and is officially approved on its own for gastrointestinal ulcers, it is not currently being targeted by anti-abortion groups,  and it is unlikely they would be able to restrict its accessibility. In addition, as it is already marketed by a number of companies and is available in generic form, increasing production is relatively easy, and Planned Parenthood clinics across the country are in the process of stocking up.

While an imperfect solution, misoprostol is easier to access than its two-drug counterpart and as doctors in the US get further training on the topic it may help to reduce the number of women forced to turn to shady online pharmacies.

Our signals coverage is powered by GlobalData’s Thematic Engine, which tags millions of data items across six alternative datasets — patents, jobs, deals, company filings, social media mentions and news — to themes, sectors and companies. These signals enhance our predictive capabilities, helping us to identify the most disruptive threats across each of the sectors we cover and the companies best placed to succeed. 

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