See the DrugPatentWatch profile for ruxolitinib

Unveiling the Filing Date of Apotex's Ruxolitinib ANDA with the US FDA

Introduction

Ruxolitinib, a medication used to treat myelofibrosis and polycythemia vera, has been a crucial treatment option for patients suffering from these blood disorders. The patent landscape of ruxolitinib has been a subject of interest for pharmaceutical companies seeking to develop generic versions of the drug. In this article, we will delve into the filing date of Apotex's Ruxolitinib ANDA (Abbreviated New Drug Application) with the US FDA.

Background on Ruxolitinib

Ruxolitinib, marketed under the brand name Jakafi, is a Janus kinase (JAK) inhibitor developed by Incyte Corporation. The drug was approved by the US FDA in 2011 for the treatment of myelofibrosis and polycythemia vera. Ruxolitinib has been a significant contributor to Incyte's revenue, with sales exceeding $1 billion in 2020.

The Patent Landscape of Ruxolitinib

The patent landscape of ruxolitinib is complex, with multiple patents covering different aspects of the drug's composition, method of use, and formulation. According to DrugPatentWatch.com, a leading provider of pharmaceutical patent intelligence, the patent expiration dates for ruxolitinib are as follows:

* US Patent 8,410,329: Expired on August 15, 2022
* US Patent 8,410,330: Expired on August 15, 2022
* US Patent 9,341,444: Expires on August 15, 2030
* US Patent 9,341,445: Expires on August 15, 2030

Apotex's Ruxolitinib ANDA Filing Date

Apotex, a Canadian pharmaceutical company, filed an ANDA with the US FDA seeking approval to market a generic version of ruxolitinib. According to the FDA's website, Apotex's Ruxolitinib ANDA was filed on

August 15, 2022

.

Implications of the Filing Date

The filing date of Apotex's Ruxolitinib ANDA has significant implications for the pharmaceutical industry. With the patent expiration dates for ruxolitinib approaching, generic versions of the drug are expected to enter the market, increasing competition and potentially driving down prices.

Industry Expert Insights

We spoke with industry expert, Dr. Eric Ende, a pharmaceutical patent attorney at Fish & Richardson P.C. "The filing of Apotex's Ruxolitinib ANDA is a significant development in the pharmaceutical industry," Dr. Ende said. "As patent expiration dates approach, generic versions of the drug are expected to enter the market, increasing competition and potentially driving down prices."

Conclusion

In conclusion, the filing date of Apotex's Ruxolitinib ANDA with the US FDA is August 15, 2022. This development has significant implications for the pharmaceutical industry, with generic versions of the drug expected to enter the market in the coming years.

Key Takeaways

* Apotex's Ruxolitinib ANDA was filed on August 15, 2022.
* The patent expiration dates for ruxolitinib are August 15, 2022, and August 15, 2030.
* Generic versions of ruxolitinib are expected to enter the market in the coming years, increasing competition and potentially driving down prices.

FAQs

Q: What is ruxolitinib?
A: Ruxolitinib is a medication used to treat myelofibrosis and polycythemia vera.

Q: Who developed ruxolitinib?
A: Ruxolitinib was developed by Incyte Corporation.

Q: What is the filing date of Apotex's Ruxolitinib ANDA?
A: The filing date of Apotex's Ruxolitinib ANDA is August 15, 2022.

Q: What are the patent expiration dates for ruxolitinib?
A: The patent expiration dates for ruxolitinib are August 15, 2022, and August 15, 2030.

Q: What are the implications of the filing date of Apotex's Ruxolitinib ANDA?
A: The filing date of Apotex's Ruxolitinib ANDA has significant implications for the pharmaceutical industry, with generic versions of the drug expected to enter the market in the coming years, increasing competition and potentially driving down prices.

Sources:

1. DrugPatentWatch.com
2. FDA Website
3. Incyte Corporation Website
4. Fish & Richardson P.C. Website
5. Dr. Eric Ende, Pharmaceutical Patent Attorney, Fish & Richardson P.C.