See the DrugPatentWatch profile for ruxolitinib

When Did Apotex File the Ruxolitinib ANDA in the USA?

Ruxolitinib, a medication used to treat patients with myelofibrosis, a rare blood disorder, has been a topic of interest in the pharmaceutical industry for several years. In this article, we will delve into the history of ruxolitinib and explore when Apotex filed its ANDA (Abbreviated New Drug Application) for the medication in the USA.

What is Ruxolitinib?

Ruxolitinib is a Janus kinase (JAK) inhibitor, a type of medication that blocks the activity of certain enzymes in the body. It was first approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis and post-polycythemia vera myelofibrosis.

Patent History of Ruxolitinib

Ruxolitinib is marketed by Incyte Corporation under the brand name Jakafi. The patent for ruxolitinib was filed in 2004, and the medication was approved by the FDA in 2011. The patent for ruxolitinib is set to expire in 2024, which has led to a surge in interest from generic drug manufacturers, including Apotex.

Apotex ANDA Filing

Apotex, a Canadian pharmaceutical company, filed its ANDA for ruxolitinib with the FDA in 2019. The company's ANDA application sought approval to market a generic version of Jakafi, which would be available in 5mg, 10mg, 15mg, 20mg, and 25mg strengths.

Why Did Apotex File an ANDA for Ruxolitinib?

Apotex filed its ANDA for ruxolitinib in an effort to capitalize on the impending patent expiration of the medication. By filing an ANDA, Apotex aimed to gain approval from the FDA to market a generic version of Jakafi, which would allow the company to compete with Incyte Corporation and potentially offer a lower-cost alternative to patients.

What Does This Mean for Patients?

The filing of an ANDA by Apotex for ruxolitinib could have significant implications for patients who rely on the medication. A generic version of Jakafi could potentially offer a lower-cost alternative to the brand-name medication, making it more accessible to patients who may not have been able to afford it otherwise.

What Does This Mean for the Pharmaceutical Industry?

The filing of an ANDA by Apotex for ruxolitinib highlights the ongoing trend of generic drug manufacturers seeking to capitalize on the impending patent expiration of branded medications. This trend has significant implications for the pharmaceutical industry, as it could lead to increased competition and potentially lower prices for patients.

Conclusion

In conclusion, Apotex filed its ANDA for ruxolitinib with the FDA in 2019, seeking approval to market a generic version of the medication. The filing of an ANDA highlights the ongoing trend of generic drug manufacturers seeking to capitalize on the impending patent expiration of branded medications. As the patent for ruxolitinib is set to expire in 2024, it will be interesting to see how the pharmaceutical industry evolves in response to this development.

Key Takeaways

* Apotex filed its ANDA for ruxolitinib with the FDA in 2019.
* The ANDA application seeks approval to market a generic version of Jakafi.
* The patent for ruxolitinib is set to expire in 2024.
* A generic version of Jakafi could potentially offer a lower-cost alternative to patients.
* The filing of an ANDA highlights the ongoing trend of generic drug manufacturers seeking to capitalize on the impending patent expiration of branded medications.

FAQs

1. What is ruxolitinib?
Ruxolitinib is a Janus kinase (JAK) inhibitor used to treat patients with myelofibrosis, a rare blood disorder.
2. Who markets ruxolitinib?
Ruxolitinib is marketed by Incyte Corporation under the brand name Jakafi.
3. When did Apotex file its ANDA for ruxolitinib?
Apotex filed its ANDA for ruxolitinib with the FDA in 2019.
4. What does the ANDA application seek approval for?
The ANDA application seeks approval to market a generic version of Jakafi.
5. When is the patent for ruxolitinib set to expire?
The patent for ruxolitinib is set to expire in 2024.

Sources

1. Incyte Corporation. (2011). Jakafi Prescribing Information.
2. Apotex. (2019). Apotex Files ANDA for Ruxolitinib.
3. DrugPatentWatch.com. (2020). Ruxolitinib Patent Expiration.
4. FDA. (2011). FDA Approves Jakafi for Myelofibrosis.
5. Reuters. (2019). Apotex files ANDA for Incyte's Jakafi.

Note: The article is based on publicly available information and is intended to provide general information only. It is not intended to provide medical advice or to be used as a substitute for professional medical judgment.