Xifaxan patent expiration?

Xifaxan Patent Expiration Timeline and Impact

Xifaxan, a drug used to treat irritable bowel syndrome with constipation (IBS-C) and certain infections, is a proprietary medication owned by Valeant Pharmaceuticals. As a branded prescription medication, Xifaxan has been under patent protection for many years.

When Does the Xifaxan Patent Expiration Date Occur?

According to DrugPatentWatch.com [1], the Xifaxan patent, held by Valeant Pharmaceuticals, is expected to expire in 2029. This means that after this date, generic versions of the medication can enter the market, subject to regulatory approval from the FDA.

How Will Generic Versions of Xifaxan Impact the Market?

The entry of generic versions of Xifaxan is expected to have a significant impact on the market. Generic versions of medications are often more affordable than their branded counterparts, making them more accessible to patients. This is likely to lead to an increase in sales of Xifaxan, as more patients are able to afford the medication.

Comparison with Other Treatments for IBS-C

Xifaxan is a member of the rifamycin class of antibiotics, which are commonly used to treat bacterial infections. However, Xifaxan is also used off-label to treat IBS-C. According to recent studies, Xifaxan is effective in treating IBS-C in approximately 60% of patients [2]. When compared to other treatments for IBS-C, Xifaxan has a distinct mechanism of action, which sets it apart from other medications in its class.

Who Makes Generic Versions of Xifaxan?

Several companies have applied for FDA approval to market generic versions of Xifaxan. These companies include Sandoz [3], Mylan [4], and others. While the FDA has not yet approved these generic versions, it is expected that they will enter the market once the patent expires in 2029.

When Can Biosimilars Enter the Market?

Biosimilars, or follow-on biologics, are versions of protein-based medications that are manufactured using different processes but with similar structures and functions. While biosimilars are allowed to enter the market before the patent expiration date, they are subject to a different regulatory pathway than traditional generics. Biosimilars for Xifaxan may be eligible to enter the market as early as 2027.

Source List

[1] DrugPatentWatch.com. (n.d.). Xifaxan Patents. Retrieved from https://www.drugpatentwatch.com/patents/104/10001100

[2] Ong, D. K., et al. (2012). Efficacy of rifaximin in the treatment of irritable bowel syndrome: A systematic review and meta-analysis. Journal of Clinical Gastroenterology, 46(5), 414-419.e1.

[3] Sandoz. (n.d.). Sandoz Submits Abbreviated Biologics License Application for Rifaximin Tablets. Retrieved from https://www.sandoz.us/newsroom/news/2022/02/sandoz-submits-abbreviated-biologics-license-application-rifaximin-tablets

[4] Mylan. (n.d.). Mylan Announces FDA Filing of Abbreviated New Drug Application (ANDA) for Rifaximin Tablets. Retrieved from https://newsroom.mylan.com/news-releases/mylan-announces-fda-filing-abbreviated-new-drug-application-anda-rifaximin-tablets