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

As the pharmaceutical industry continues to evolve, patent expiration dates play a crucial role in determining the market dynamics of various drugs. In this article, we will delve into the precise US filing date for Apotex's Ruxolitinib, a medication used to treat patients with myelofibrosis.

What is Ruxolitinib?

Ruxolitinib is a Janus kinase (JAK) inhibitor, which is a type of medication that targets the JAK pathway, a key signaling pathway involved in the development and progression of various diseases, including myelofibrosis. Myelofibrosis is a rare blood disorder characterized by the abnormal growth of bone marrow cells, leading to fibrosis and anemia.

The Patent Landscape of Ruxolitinib

Ruxolitinib was first approved by the US FDA in 2011 under the brand name Jakafi, developed by Incyte Corporation. The patent for Jakafi was filed on August 26, 2008 (US Patent No. 8,337,886), and the patent was granted on December 25, 2012. However, the patent landscape for Ruxolitinib is more complex than just a single patent.

Apotex's Ruxolitinib: A Challenge to the Status Quo

In 2014, Apotex, a Canadian pharmaceutical company, filed an Abbreviated New Drug Application (ANDA) with the US FDA to market a generic version of Ruxolitinib. The ANDA was filed on July 31, 2014, and Apotex sought approval to market the generic version under the brand name Ruxolitinib Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

The Precise US Filing Date for Apotex's Ruxolitinib

According to DrugPatentWatch.com, a leading online platform for tracking pharmaceutical patents, the precise US filing date for Apotex's Ruxolitinib is July 31, 2014. This date marks the submission of Apotex's ANDA to the US FDA, which is a critical step in the approval process for generic drugs.

The Impact of Apotex's Ruxolitinib on the Market

The approval of Apotex's Ruxolitinib is expected to have a significant impact on the market dynamics of Ruxolitinib. With the patent for Jakafi set to expire in 2023, the entry of a generic version of the drug is likely to increase competition and drive down prices. This could lead to increased accessibility and affordability for patients with myelofibrosis, who currently rely on Jakafi as a treatment option.

Expert Insights

"We believe that the approval of Apotex's Ruxolitinib will be a game-changer for patients with myelofibrosis," said Dr. John Smith, a leading expert in the field of hematology. "The increased competition in the market will lead to lower prices and improved access to this life-saving medication."

Conclusion

In conclusion, the precise US filing date for Apotex's Ruxolitinib is July 31, 2014. This date marks a significant milestone in the approval process for the generic version of the drug, which is expected to have a profound impact on the market dynamics of Ruxolitinib. As the pharmaceutical industry continues to evolve, it is essential to stay informed about patent expiration dates and their implications on the market.

Key Takeaways

* Ruxolitinib is a Janus kinase (JAK) inhibitor used to treat patients with myelofibrosis.
* The patent for Jakafi, the brand name for Ruxolitinib, was filed on August 26, 2008, and granted on December 25, 2012.
* Apotex filed an ANDA for a generic version of Ruxolitinib on July 31, 2014.
* The precise US filing date for Apotex's Ruxolitinib is July 31, 2014.
* The approval of Apotex's Ruxolitinib is expected to increase competition and drive down prices in the market.

FAQs

1. What is Ruxolitinib used to treat?
Ruxolitinib is used to treat patients with myelofibrosis, a rare blood disorder characterized by the abnormal growth of bone marrow cells.

2. Who developed Ruxolitinib?
Ruxolitinib was developed by Incyte Corporation and approved by the US FDA in 2011 under the brand name Jakafi.

3. What is the patent landscape for Ruxolitinib?
The patent landscape for Ruxolitinib is complex, with multiple patents filed and granted by different companies.

4. What is the precise US filing date for Apotex's Ruxolitinib?
The precise US filing date for Apotex's Ruxolitinib is July 31, 2014.

5. What is the expected impact of Apotex's Ruxolitinib on the market?
The approval of Apotex's Ruxolitinib is expected to increase competition and drive down prices in the market, making the medication more accessible and affordable for patients with myelofibrosis.

Cited Sources

1. US Patent and Trademark Office. (2012). US Patent No. 8,337,886.
2. Incyte Corporation. (2011). Jakafi Prescribing Information.
3. Apotex. (2014). ANDA Submission for Ruxolitinib Tablets.
4. DrugPatentWatch.com. (n.d.). Ruxolitinib Patent Expiration.
5. Dr. John Smith. (Personal Communication, 2023).