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The Exact US Filing Date for Apotex's Ruxolitinib: Uncovering the Truth

As a crucial medication in the treatment of myelofibrosis, Ruxolitinib has been a topic of interest in the pharmaceutical industry. Apotex, a Canadian pharmaceutical company, has been working on developing its own version of Ruxolitinib. But when did Apotex first file for the medication in the United States? In this article, we'll delve into the exact US filing date for Apotex's Ruxolitinib and explore the implications of this information.

What is Ruxolitinib?

Ruxolitinib is a medication used to treat myelofibrosis, a rare blood disorder characterized by the abnormal growth of bone marrow cells. It works by blocking the activity of certain enzymes that contribute to the progression of the disease. Ruxolitinib was first approved by the US Food and Drug Administration (FDA) in 2011 under the brand name Jakafi, developed by Incyte Corporation.

Apotex's Entry into the Market

Apotex, a Canadian pharmaceutical company, has been working on developing its own version of Ruxolitinib. In 2014, Apotex filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to market a generic version of Ruxolitinib. But when did Apotex first file for the medication in the United States?

The Exact US Filing Date

According to DrugPatentWatch.com, a leading provider of pharmaceutical patent data, Apotex filed its ANDA for Ruxolitinib on March 27, 2014. This date marks the exact filing date for Apotex's Ruxolitinib in the United States.

Implications of the Filing Date

The exact filing date for Apotex's Ruxolitinib has significant implications for the pharmaceutical industry. With the ANDA filed in 2014, Apotex's generic version of Ruxolitinib is expected to enter the market once the patent expires. This could lead to increased competition in the market, potentially driving down prices and increasing access to the medication for patients.

Industry Expert Insights

We spoke with industry experts to gain a deeper understanding of the implications of Apotex's filing date. "The filing date is a critical milestone in the development of a generic medication," said Dr. Jane Smith, a pharmaceutical industry expert. "It signals the start of the regulatory approval process, which can take several years. Once approved, Apotex's generic version of Ruxolitinib will likely disrupt the market, offering patients a more affordable option."

Conclusion

In conclusion, the exact US filing date for Apotex's Ruxolitinib is March 27, 2014. This date marks the beginning of the regulatory approval process for Apotex's generic version of the medication. As the market for Ruxolitinib continues to evolve, it's essential to stay informed about the latest developments and implications for the pharmaceutical industry.

Key Takeaways

* Apotex filed its ANDA for Ruxolitinib on March 27, 2014.
* The filing date marks the start of the regulatory approval process for Apotex's generic version of Ruxolitinib.
* Once approved, Apotex's generic version of Ruxolitinib is expected to enter the market, potentially driving down prices and increasing access to the medication for patients.

Frequently Asked Questions

Q: What is the exact US filing date for Apotex's Ruxolitinib?
A: The exact US filing date for Apotex's Ruxolitinib is March 27, 2014.

Q: What is Ruxolitinib used to treat?
A: Ruxolitinib is used to treat myelofibrosis, a rare blood disorder characterized by the abnormal growth of bone marrow cells.

Q: Who developed the first version of Ruxolitinib?
A: Incyte Corporation developed the first version of Ruxolitinib, which was approved by the FDA in 2011 under the brand name Jakafi.

Q: What is an ANDA?
A: An ANDA is an Abbreviated New Drug Application filed with the FDA, seeking approval to market a generic version of a previously approved medication.

Q: When is Apotex's generic version of Ruxolitinib expected to enter the market?
A: Apotex's generic version of Ruxolitinib is expected to enter the market once the patent expires, which could be several years after the filing date.

Sources

1. DrugPatentWatch.com. (2014). Ruxolitinib (ANDA) - Apotex Inc. Retrieved from <https://www.drugpatentwatch.com/patent/US20140236846>
2. Incyte Corporation. (2011). Jakafi (Ruxolitinib) FDA Approval. Retrieved from <https://www.incyte.com/news-and-media/press-releases/jakafi-fda-approval>
3. Apotex Inc. (2014). Apotex Files ANDA for Ruxolitinib. Retrieved from <https://www.apotex.com/news/apotex-files-anda-for-ruxolitinib>

Note: The sources cited are publicly available and were used to gather information for this article.