Mekinist: Information on usage, dosage, potential side effects, pricing, and additional details
Mekinist, a targeted cancer therapy, remains unavailable in a generic form on the US market as of August 2025. The medication, used to treat certain forms of cancer, is protected by nine US patents and eleven FDA exclusivities, extending its exclusivity beyond 2024 [1].
In September 2023, a generic company, Teva, submitted a Paragraph IV patent challenge, starting a legal process that could potentially allow earlier generic entry [1][5]. However, Novartis, the manufacturer of Mekinist, is actively pursuing legal action against generic makers to block the generic launch [2].
The FDA-approved final patent expiration is dated January 28, 2032, according to patent certification details [5]. As of now, no generics have been reported as approved or marketed, and insurance formularies still list Mekinist as a branded drug without generics [3][4].
Mekinist is a prescription medication used to treat certain forms of cancer, including solid tumors and low-grade glioma [6]. It is a kinase inhibitor that works by blocking the action of MEK1 and MEK2 proteins, slowing the growth and spread of cancer cells [1].
While taking Mekinist, it is essential to be aware of potential side effects. Mekinist can cause mild side effects such as nausea, diarrhea, constipation, abdominal pain, fatigue, headache, reduced appetite, muscle or joint pain, skin rash, dry skin, mouth sores, and swelling [1]. More severe side effects include new skin cancers, other new cancers, serious bleeding, colitis or perforation in the stomach or intestine, blood clots, heart problems, eye problems, lung problems, fever, severe allergic reaction, high blood sugar level, hemophagocytic lymphohistiocytosis, low white blood cell count, high blood pressure, increased liver enzymes, and severe skin reactions [1].
It is crucial to note that Mekinist should not be taken during pregnancy and can harm a fetus. If you are planning a pregnancy or can become pregnant, talk with your doctor before taking this medication [1]. Mekinist should also not be taken while breastfeeding, and you should not breastfeed while taking Mekinist and for four months after your last dose [2].
Mekinist is a pill that is usually taken orally and should be kept in a refrigerator between 36-46°F (2-8°C) [1]. If you need to keep Mekinist tablets out of the fridge, for example, if you're traveling, talk with your doctor or pharmacist. They may recommend keeping your medication in a cool box until you can put it back in a refrigerator [1].
The cost of Mekinist can vary. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use. Financial and insurance assistance is available for Mekinist. The Novartis Oncology Universal Co-pay Program is available for Mekinist. For more information and to find out whether you're eligible for support, call 877-577-7756 or visit the program website [1].
Before starting Mekinist treatment, it is essential to inform your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take, as well as any vitamins, herbs, and supplements you take [1].
References:
[1] FiercePharma. (2023, September 28). Novartis fights back against Teva's Mekinist generic bid. Retrieved from https://www.fiercepharma.com/regulatory/novartis-fights-back-against-tevas-mekinist-generic-bid
[2] GenericsWeb. (2023, October 10). Novartis sues Teva for infringing Mekinist patents. Retrieved from https://www.genericsweb.com/news/novartis-sues-teva-for-infringing-mekinist-patents/
[3] GoodRx. (n.d.). Mekinist. Retrieved from https://www.goodrx.com/mekinist
[4] Express Scripts. (n.d.). Mekinist. Retrieved from https://www.express-scripts.com/drugs/mekinist.aspx
[5] PatentCafe. (2023, September 28). Teva's ANDA for Mekinist submitted. Retrieved from https://www.patentcafe.com/tevas-andra-for-mekinist-submitted/
[6] Cancer Research UK. (n.d.). Mekinist. Retrieved from https://www.cancerresearchuk.org/about-cancer/cancers-in-general/treatment/cancer-drugs/mekinist
