See the DrugPatentWatch profile for ruxolitinib

When Did Apotex File Its Ruxolitinib ANDA with the FDA?

Ruxolitinib, a Janus kinase (JAK) inhibitor, is a medication used to treat patients with myelofibrosis, a type of blood cancer. The drug was first approved by the US Food and Drug Administration (FDA) in 2011 under the brand name Jakafi, developed by Incyte Corporation. However, the patent for Jakafi is set to expire in 2024, which has led to interest from generic manufacturers looking to file Abbreviated New Drug Applications (ANDAs) with the FDA.

The Patent Landscape of Ruxolitinib

Ruxolitinib's patent landscape is complex, with multiple patents filed by Incyte Corporation and other companies. According to DrugPatentWatch.com, the original patent for ruxolitinib, US Patent 7,553,662, was filed in 2007 and granted in 2009. This patent covers the composition of matter for ruxolitinib and is set to expire in 2024.

Apotex's Ruxolitinib ANDA

Apotex, a Canadian generic pharmaceutical company, has been working on developing a generic version of ruxolitinib. In 2019, Apotex filed an ANDA with the FDA seeking approval to market a generic version of ruxolitinib tablets. The ANDA was filed under Section 505(j) of the Federal Food, Drug, and Cosmetic Act, which allows generic manufacturers to file applications for approval to market a generic version of a branded drug.

Timeline of Apotex's Ruxolitinib ANDA

While Apotex filed its ANDA in 2019, the company has been working on developing its generic version of ruxolitinib for several years prior. According to a press release from Apotex, the company began developing its generic version of ruxolitinib in 2016. This timeline suggests that Apotex likely began conducting clinical trials and gathering data to support its ANDA application several years before filing.

What's Next for Apotex's Ruxolitinib ANDA?

The FDA has not yet approved Apotex's ANDA, and the company is likely still awaiting a decision from the agency. Once approved, Apotex's generic version of ruxolitinib will be able to enter the market, potentially offering a more affordable option for patients and healthcare providers.

Conclusion

The patent landscape of ruxolitinib is complex, with multiple patents filed by Incyte Corporation and other companies. Apotex has filed an ANDA with the FDA seeking approval to market a generic version of ruxolitinib, and the company has been working on developing its generic version for several years. While the FDA has not yet approved Apotex's ANDA, the company is likely still awaiting a decision from the agency.

Frequently Asked Questions

1. When did Apotex file its ANDA with the FDA?
Apotex filed its ANDA with the FDA in 2019.
2. What is the patent landscape of ruxolitinib?
The patent landscape of ruxolitinib is complex, with multiple patents filed by Incyte Corporation and other companies.
3. What is the status of Apotex's ANDA?
The FDA has not yet approved Apotex's ANDA, and the company is likely still awaiting a decision from the agency.
4. When is the patent for Jakafi set to expire?
The patent for Jakafi is set to expire in 2024.
5. What is the potential impact of Apotex's generic version of ruxolitinib on the market?
The potential impact of Apotex's generic version of ruxolitinib on the market is increased competition and potentially lower prices for patients and healthcare providers.

Cited Sources

1. Apotex. (2019). Apotex Files ANDA for Generic Version of Ruxolitinib Tablets. Retrieved from <https://www.apotex.com/news/2019/apotex-files-anda-for-generic-version-of-ruxolitinib-tablets/>
2. DrugPatentWatch.com. (n.d.). Ruxolitinib (Jakafi) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration-dates/ruxolitinib-jakafi>
3. Incyte Corporation. (2011). Incyte Corporation Announces FDA Approval of Jakafi (ruxolitinib) for the Treatment of Patients with Intermediate or High-Risk Myelofibrosis. Retrieved from <https://www.incyte.com/news-and-media/press-releases/incyte-corporation-announces-fda-approval-of-jakafi-ruxolitinib-for-the-treatment-of-patients-with-intermediate-or-high-risk-myelofibrosis>