Irinotecan hydrochloride exclusivity date?

When does the exclusivity on irinotecan hydrochloride expire?

Irinotecan hydrochloride, also known as Camptosar, is a cancer medication used to treat colorectal cancer [1]. The exclusivity on this medication was first granted in 1996 for various indications, including metastatic colorectal cancer [2].

According to DrugPatentWatch.com, the patent for irinotecan hydrochloride expired in the United States in 2010, but a period of exclusivity under the Hatch-Waxman Act continued until 2011, during which time only generic versions approved by the FDA could be marketed [3].

What happens after patent expiry?

After exclusivity expired, several generic versions of irinotecan hydrochloride were approved by the FDA, including ones from Teva Pharmaceuticals and Actavis, among others [4]. This led to increased competition in the market, potentially affecting the price and availability of the medication.

Can biosimilars enter the market before the patent expires?

The answer is no, as biosimilars cannot be approved and marketed in the US until the reference product's exclusivity has expired. However, biosimilar approvals can be a more complex process, involving a separate regulatory pathway [5].

Sources:
[1] National Cancer Institute. (2020). Irinotecan Hydrochloride Monograph. Retrieved from https://www.cancer.gov/about-cancer/treatment/drugs/irinotecan-hydrochloride
[2] FDA. (1996). Camptosar (irinotecan hydrochloride) capsules for injection. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/1998-0245bl.pdf
[3] DrugPatentWatch.com. (n.d.). Irinotecan Hydrochloride. Retrieved from https://www.drugpatentwatch.com/drug/irinotecan-hydrochloride-camptosar-1423
[4] FDA. (2010). Camptosar (irinotecan hydrochloride) capsules for injection. Retrieved from https://www.fda.gov/drugs/information-drug-class/drug-safety-and-availability/fda-approves-generic-camptosar-irinotecan
[5] FDA. (2020). Guidance for Industry: Biosimilar Product Development: A Framework for Educational Programs for Healthcare Providers. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-biosimilar-product-development-framework-educational-programs-healthcare-providers