Eliquis is Bleeding Patients’ Wallets Dry

Written By: Annie Weyand, PharmD Candidate 2024 (Pitt) and Abby Robb, PharmD Candidate 2024 (Duquesne)

Eliquis is a direct oral anticoagulant (DOAC) that works to prevent blood clot formation by thinning the blood.¹ It was initially approved in 2012 by the FDA in patients with non-valvular atrial fibrillation to reduce the risk of blood clot formation leading to a stroke.¹ ² Then, in March of 2014, the FDA approved Eliquis for prevention of blood clots forming in deep veins, such as the legs, in patients receiving hip or knee replacements. Finally, in August of 2014, the FDA approved Eliquis for the treatment and prevention of VTE (venous thromboembolism), otherwise known as a blood clot formation in the deep veins (deep vein thrombosis) or in the lungs (pulmonary embolism). Eliquis is a favorable blood thinner because of its fast onset, predictable effects, and avoidance of routine lab monitoring compared to warfarin, which is an older blood thinner.² ³ Although it is more favorable than warfarin, today many patients struggle to access this medication because it is sold as a high cost brand-name only product.⁴

Eliquis, as brand-name only, is manufactured by Bristol-Myers Squibb (BMS) and marketed by both BMS and Pfizer.¹ In December of 2019, the FDA approved the generic of Eliquis, known as apixaban. In the press release, the FDA shared that Micro Labs Limited and Mylan Pharmaceuticals Inc. were approved to manufacture apixaban. Although the composition of matter (COM) patent for Eliquis was supposed to expire February 2023, BMS and Pfizer were able to maintain exclusive rights to brand-name only Eliquis, preventing Micro Labs Limited and Mylan Pharmaceuticals Inc from selling generic apixaban.⁴ ⁵ BMS and Pfizer were able to uphold their patents through lawsuits filed against companies looking to sell apixaban before it was actually approved as a generic. Then, in August of 2020, the court ruled in favor of continuing to support the COM patent and formulation patent, preventing the production and sale of generic apixaban. Furthermore, the U.S. Patent and Trademark Office extended the COM patent from February 2023 to November 2026. With this ruling, the earliest Eliquis is now able to be manufactured as generic apixaban is April 1, 2028.⁶ ⁷ ⁸

To be FDA approved, manufactured, and sold, generic medications must reach a set of standards proving that they are equivalent to the branded product. Some of the elements that must be equivalent to the brand include active ingredient, strength, form/route of administration, and manufacturing standards. Inactive ingredients may vary from the brand as long as they do not have an effect on the function of the drug.⁹ In addition to being FDA approved before manufacturing a generic product, generic manufacturers must wait until the patents on the brand medications expire. A patent on a brand medication can last for about 20 years from the time the manufacturer applies for it. Sometimes the brand medication may only have 10 years out of the 20 years actually being sold on the market due to the lengthy process of research, development, and FDA approval. Manufacturer’s who are producing brand medications are able to extend their patents in certain ways, such as finding new diagnoses that the medication can treat.¹⁰ ¹¹ Patent extension or restoration is commonly done by pharmaceutical companies in hopes of continuing to make revenue off of the medication. In fact, more than 70% of the 100 top-selling drugs have had their patents extended at least once.¹² In the case of Eliquis, BMS and Pfizer are benefitting from extending their patents since Eliquis is a top-selling drug with about $7.9 billion in sales in 2019 alone.⁸

The reason generic medications are able to be cheaper than branded products is because of the abbreviated application process and the avoidance of having to repeat clinical studies. In addition, when the patent for a branded product expires many companies are able to produce the generic medication leading to competitive prices between manufacturers and the ability for pharmacies to purchase the medication at a lower cost.⁹ Blueberry Pharmacy owner, Kyle McCormick states that, “in the same way brand-only Latuda went from costing around $1000 to being about $3 as generic lurasidone, Eliquis is expected to decrease greatly in cost once it can be sold as generic apixaban.” He continues by saying, “once Eliquis is sold as generic apixaban, more than 92% of prescriptions will be available as generic.”

In conclusion, Eliquis is a common medication many patients are on today to prevent a stroke caused by a blood clot. Although it is a favorable blood thinner compared to warfarin, patients struggle to access this medication because of the high cost as a brand-name only product. Once Eliquis is able to be manufactured and sold as generic apixaban in 2028, patients will have an easier time affording this life-saving medication.

References:

1. Eliquis (apixaban) package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2012 Dec
2. Eliquis FDA approval history. Drugs.com. https://www.drugs.com/history/eliquis.html (accessed 2023 July 23)
3. Hurst KV, O’Callaghan JM, Handa A. Quick reference guide to apixaban [published correction appears in Vasc Health Risk Manag. 2017 Oct 26;13:413]. Vasc Health Risk Manag. 2017;13:263–267.
4. Eliquis (apixaban) and cost. Medical News Today. https://www.medicalnewstoday.com/articles/drugs-eliquis-cost (accessed 2023 July 23).
5. FDA approves first generics of Eliquis. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis (accessed 2023 July 23).
6. The Bristol Myers Squibb-Pfizer Alliance is pleased with the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis® Patents. Bristol Myers Squibb. https://news.bms.com/news/details/2021/The-Bristol-Myers-Squibb-Pfizer-Alliance-is-pleased-with-the-decision-by-the-U.S.-Court-of-Appeals-for-the-Federal-Circuit-upholding-the-Eliquis-Patents/default.aspx (accessed 2023 July 23).
7. Liu, A; First generics to Bristol-Myers and Pfizer’s Eliquis are here. Fierce Pharma. But can they launch before 2026? https://www.fiercepharma.com/pharma/first-generics-to-bristol-myers-and-pfizer-s-eliquis-are-here-but-might-not-launch-until (accessed 2023 July 23).
8. Bristol-Myers and Pfizer win over Eliquis patents. JDSUPRA. https://www.jdsupra.com/legalnews/bristol-myers-and-pfizer-win-over-31202/ (accessed 2023 July 31).
9. Generic drugs: questions & answers. U.S. Food and Drug Administration. https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers (accessed 2023 July 28).
10. How Long Do Drug Patents Last: Everything You Need to Know. Upcounsel. https://www.upcounsel.com/how-long-do-drug-patents-last (accessed 2023 July 28).
11. Drug patent expirations and the “patent cliff.” U.S. Pharmacist. https://www.uspharmacist.com/article/drug-patent-expirations-and-the-patent-cliff (accessed 2023 July 28).
12. Beal, K; The FDA approved a generic version of Eliquis, but it won’t be available for several years. Fox Carolina. https://www.foxcarolina.com/2023/01/14/fda-approved-generic-version-eliquis-it-wont-be-available-several-years/ (accessed 2023 July 31).