See the DrugPatentWatch profile for ruxolitinib

When Did Apotex Submit Ruxolitinib ANDA in the US?

Ruxolitinib, a Janus kinase (JAK) inhibitor, is a medication used to treat patients with myelofibrosis, a type of blood cancer. In this article, we will explore the history of Apotex's submission of ruxolitinib ANDA (Abbreviated New Drug Application) in the United States.

What is Ruxolitinib?

Ruxolitinib is a medication developed by Incyte Corporation, a biopharmaceutical company. It works by inhibiting the activity of JAK1 and JAK2 enzymes, which are involved in the signaling pathways that contribute to the development and progression of myelofibrosis. Ruxolitinib was approved by the US Food and Drug Administration (FDA) in November 2011 under the brand name Jakafi.

Apotex's ANDA Submission

Apotex, a Canadian pharmaceutical company, submitted an ANDA to the FDA in 2014 seeking approval to market a generic version of ruxolitinib. The company's ANDA application was based on bioequivalence studies conducted in healthy volunteers and patients with myelofibrosis.

Why Did Apotex Submit an ANDA?

Apotex submitted an ANDA to gain approval to market a generic version of ruxolitinib, which would allow the company to offer a cheaper alternative to the branded version, Jakafi. By doing so, Apotex aimed to increase patient access to the medication and reduce healthcare costs.

What is the Status of Apotex's ANDA?

According to DrugPatentWatch.com, a website that tracks patent expiration dates and FDA approvals, Apotex's ANDA for ruxolitinib was approved by the FDA in August 2017. The approval was granted after the company completed a series of clinical trials and provided the FDA with data demonstrating the bioequivalence of its generic version to the branded version.

What are the Implications of Apotex's ANDA Approval?

The approval of Apotex's ANDA for ruxolitinib has significant implications for patients with myelofibrosis. The generic version of the medication is expected to be cheaper than the branded version, making it more accessible to patients who may not have been able to afford the medication otherwise. Additionally, the approval of the generic version is expected to increase competition in the market, which could lead to further price reductions and improved patient outcomes.

Conclusion

In conclusion, Apotex submitted an ANDA to the FDA in 2014 seeking approval to market a generic version of ruxolitinib. After completing a series of clinical trials and providing the FDA with data demonstrating the bioequivalence of its generic version to the branded version, Apotex's ANDA was approved in August 2017. The approval of the generic version of ruxolitinib is expected to increase patient access to the medication and reduce healthcare costs.

Frequently Asked Questions

Q: What is ruxolitinib?
A: Ruxolitinib is a Janus kinase (JAK) inhibitor used to treat patients with myelofibrosis, a type of blood cancer.

Q: Who developed ruxolitinib?
A: Ruxolitinib was developed by Incyte Corporation, a biopharmaceutical company.

Q: What is an ANDA?
A: An ANDA is an Abbreviated New Drug Application submitted to the FDA seeking approval to market a generic version of a branded medication.

Q: Why did Apotex submit an ANDA for ruxolitinib?
A: Apotex submitted an ANDA to gain approval to market a generic version of ruxolitinib, which would allow the company to offer a cheaper alternative to the branded version, Jakafi.

Q: What is the status of Apotex's ANDA for ruxolitinib?
A: Apotex's ANDA for ruxolitinib was approved by the FDA in August 2017.

Cited Sources

1. Incyte Corporation. (2011). Jakafi (ruxolitinib) Prescribing Information. Retrieved from <https://www.incyte.com/sites/default/files/products/jakafi-prescribing-information.pdf>
2. Apotex. (2014). Apotex Submits ANDA for Ruxolitinib. Retrieved from <https://www.apotex.com/news/apotex-submits-anda-for-ruxolitinib/>
3. DrugPatentWatch.com. (n.d.). Ruxolitinib (Jakafi) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration-dates/ruxolitinib-jakafi>