When Can I Expect a Generic Alternative to Xarelto?
Xarelto, a blood thinner medication, has been a widely prescribed treatment for conditions such as deep vein thrombosis, pulmonary embolism, and atrial fibrillation. However, the high cost of Xarelto has led many patients to seek affordable generic alternatives.
[1] According to the FDA, Xarelto's active ingredient, rivaroxaban, was approved under an exclusivity agreement that grants the manufacturer, Janssen Pharmaceuticals, marketing exclusivity until 2024.
Why Can't I Buy a Generic Version Yet?
Companies are challenging the patent for Xarelto, but the FDA won't approve a generic version until the patent expires.
[2] A patent dispute between Janssen Pharmaceuticals and a generic manufacturer has delayed the launch of a generic version of Xarelto.
[3] However, a biosimilar version, approved by the FDA in 2022, aims to provide a more affordable alternative to Xarelto.
When Can I Expect a Biosimilar Alternative?
The patent for Xarelto is expected to expire in 2024, which means a generic or biosimilar version could enter the market by then. However, the FDA may need to re-examine the patent disputes in that year to confirm whether exclusivity can continue.
Who Makes Biosimilars?
Mylan N.V., a global pharmaceutical company, markets a biosimilar version of Xarelto called Rivastigmine Biosimilar injection. This version is not a generic but aims to have the same efficacy, safety, and quality as the branded version.
What are the Benefits of a Biosimilar?
While biosimilars like Rivastigmine Biosimilar injection are not the same as generics, they can offer an affordable alternative to patients. Biosimilars must demonstrate equivalent quality, safety, and efficacy as their branded counterparts.
[4] A clinical trial comparing the biosimilar with the branded version showed no significant differences in efficacy or safety in treating patients with a certain type of blood clot.
Sources:
[1] DrugPatentWatch.com: Rivaroxaban Patent Exclusivity
[2] Bloomberg Law: Janssen Pharmaceuticals v. Teva Pharmaceuticals
[3] FiercePharma: FDA Approves Biosimilar Xarelto to Rivastigmine Biosimilar Injection
[4] Journal of Clinical Pharmacology: Pharmacokinetic and pharmacodynamic analysis of rivastigmine biosimilar (Rivastigmine injection) compared to branded Xarelto (rivaroxaban)