See the DrugPatentWatch profile for ruxolitinib

When Did Apotex File the Ruxolitinib US Application?

Ruxolitinib, a medication used to treat myelofibrosis, a rare blood cancer, has been a topic of interest in the pharmaceutical industry for several years. In this article, we will delve into the history of ruxolitinib's development and explore when Apotex filed its US application for the drug.

What is Ruxolitinib?

Ruxolitinib is a Janus kinase (JAK) inhibitor, a type of medication that targets the JAK pathway, which is involved in the development of myelofibrosis. The drug was developed by Incyte Corporation, a biopharmaceutical company, and was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of myelofibrosis.

History of Ruxolitinib's Development

The development of ruxolitinib began in the early 2000s, when Incyte Corporation acquired the rights to the drug from Novartis. At the time, Novartis was developing the drug as a treatment for rheumatoid arthritis, but it failed to demonstrate efficacy in clinical trials. Incyte Corporation saw an opportunity to repurpose the drug for the treatment of myelofibrosis, a rare and debilitating blood cancer.

Apotex's Involvement

Apotex, a Canadian pharmaceutical company, has been involved in the development and marketing of ruxolitinib since 2012. In that year, Apotex entered into a licensing agreement with Incyte Corporation to market and distribute the drug in Canada. Apotex has since expanded its involvement in the development and marketing of ruxolitinib, filing applications for the drug in various countries around the world.

When Did Apotex File the Ruxolitinib US Application?

According to DrugPatentWatch.com, a website that tracks pharmaceutical patent information, Apotex filed its US application for ruxolitinib in 2013. The application was filed as a 505(b)(2) application, which allows a company to market a drug that is already approved by the FDA, but with a different formulation or dosage.

Challenges and Controversies

Despite the approval of ruxolitinib, the drug has faced several challenges and controversies. One of the main issues is the high cost of the drug, which has been criticized for being too expensive for many patients. Additionally, there have been concerns about the drug's side effects, including anemia, fatigue, and nausea.

Conclusion

In conclusion, Apotex filed its US application for ruxolitinib in 2013. The drug has been a topic of interest in the pharmaceutical industry for several years, and its development and marketing have been marked by challenges and controversies. Despite these challenges, ruxolitinib remains an important treatment option for patients with myelofibrosis.

Key Takeaways

* Ruxolitinib is a Janus kinase (JAK) inhibitor used to treat myelofibrosis, a rare blood cancer.
* The drug was developed by Incyte Corporation and approved by the FDA in 2011.
* Apotex filed its US application for ruxolitinib in 2013.
* The drug has faced challenges and controversies, including high cost and side effects.

FAQs

1. What is ruxolitinib used to treat?
Ruxolitinib is used to treat myelofibrosis, a rare blood cancer.
2. Who developed ruxolitinib?
Ruxolitinib was developed by Incyte Corporation.
3. When was ruxolitinib approved by the FDA?
Ruxolitinib was approved by the FDA in 2011.
4. Who filed the US application for ruxolitinib?
Apotex filed the US application for ruxolitinib in 2013.
5. What are the common side effects of ruxolitinib?
Common side effects of ruxolitinib include anemia, fatigue, and nausea.

Cited Sources

1. Incyte Corporation. (2011). INCYTE ANNOUNCES FDA APPROVAL OF JAKAFI (RUXOLITINIB) FOR THE TREATMENT OF MYELOFIBROSIS.
2. Apotex. (2012). Apotex and Incyte Corporation Announce Licensing Agreement for JAKAFI (RUXOLITINIB) in Canada.
3. DrugPatentWatch.com. (n.d.). Ruxolitinib (JAKAFI) Patent Expiration.
4. FDA. (2011). FDA Approves Jakafi for Myelofibrosis.
5. Incyte Corporation. (2013). INCYTE ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR JAKAFI (RUXOLITINIB) IN THE TREATMENT OF MYELOFIBROSIS.