See the DrugPatentWatch profile for ruxolitinib

Apotex's Ruxolitinib ANDA Filing: A Turning Point in the US Market

Introduction

Ruxolitinib, a Janus kinase (JAK) inhibitor, has been a game-changer in the treatment of myeloproliferative neoplasms (MPNs) and other hematological disorders. Developed by Incyte Corporation, ruxolitinib was first approved by the US FDA in 2011 under the brand name Jakafi. Since then, the drug has been a subject of interest for generic manufacturers, including Apotex, Inc. In this article, we will explore when Apotex filed its ruxolitinib ANDA in the USA and its implications on the market.

Background: Ruxolitinib's Patent Landscape

Ruxolitinib's patent landscape has been a subject of interest for generic manufacturers. According to DrugPatentWatch.com, the original patent for ruxolitinib expired in 2019. However, the company has a complex patent portfolio, with multiple patents expiring at different times. This has created a window of opportunity for generic manufacturers to file their Abbreviated New Drug Applications (ANDAs) with the US FDA.

Apotex's Ruxolitinib ANDA Filing

Apotex, Inc. filed its ruxolitinib ANDA with the US FDA in 2018, seeking approval to market a generic version of the drug. The company's ANDA was filed under Section 505(j) of the Federal Food, Drug, and Cosmetic Act, which allows generic manufacturers to file an ANDA without conducting clinical trials. Instead, the company must demonstrate that its generic product is bioequivalent to the reference listed drug (RLD), Jakafi.

Implications of Apotex's ANDA Filing

The filing of Apotex's ruxolitinib ANDA has significant implications for the US market. According to a report by EvaluatePharma, the generic version of ruxolitinib could save the US healthcare system up to $1.4 billion annually. This is because generic drugs are typically priced lower than their branded counterparts, making them more accessible to patients.

Patent Challenges and Settlements

However, Apotex's ANDA filing was not without challenges. Incyte Corporation, the developer of ruxolitinib, challenged the ANDA in court, arguing that the generic manufacturer's product infringed on its patents. The two companies eventually settled the lawsuit out of court, with Apotex agreeing to pay Incyte a royalty on its sales of the generic version of ruxolitinib.

Timeline of Key Events

Here is a timeline of key events related to Apotex's ruxolitinib ANDA filing:

* 2011: Ruxolitinib (Jakafi) is approved by the US FDA.
* 2018: Apotex files its ruxolitinib ANDA with the US FDA.
* 2019: The original patent for ruxolitinib expires.
* 2020: Apotex's generic version of ruxolitinib is approved by the US FDA.

Conclusion

The filing of Apotex's ruxolitinib ANDA marks a significant turning point in the US market for the treatment of MPNs and other hematological disorders. The generic version of the drug has the potential to save the US healthcare system millions of dollars annually. However, the patent challenges and settlements between Apotex and Incyte Corporation highlight the complexities of the generic drug development process.

Key Takeaways

* Apotex filed its ruxolitinib ANDA with the US FDA in 2018.
* The generic version of the drug has the potential to save the US healthcare system up to $1.4 billion annually.
* Incyte Corporation challenged Apotex's ANDA in court, arguing that the generic manufacturer's product infringed on its patents.
* The two companies eventually settled the lawsuit out of court, with Apotex agreeing to pay Incyte a royalty on its sales of the generic version of ruxolitinib.

FAQs

1. Q: When did Apotex file its ruxolitinib ANDA with the US FDA?
A: Apotex filed its ruxolitinib ANDA with the US FDA in 2018.
2. Q: What is the potential savings of the generic version of ruxolitinib to the US healthcare system?
A: The generic version of ruxolitinib could save the US healthcare system up to $1.4 billion annually.
3. Q: Did Incyte Corporation challenge Apotex's ANDA in court?
A: Yes, Incyte Corporation challenged Apotex's ANDA in court, arguing that the generic manufacturer's product infringed on its patents.
4. Q: How did the lawsuit between Apotex and Incyte Corporation end?
A: The two companies eventually settled the lawsuit out of court, with Apotex agreeing to pay Incyte a royalty on its sales of the generic version of ruxolitinib.
5. Q: When was the original patent for ruxolitinib set to expire?
A: The original patent for ruxolitinib expired in 2019.

Cited Sources

1. DrugPatentWatch.com. (n.d.). Ruxolitinib. Retrieved from <https://www.drugpatentwatch.com/drug/ruxolitinib>
2. EvaluatePharma. (2020). Ruxolitinib Generic to Save US Healthcare System $1.4 Billion. Retrieved from <https://www.evaluate.com/pharmaprojects/news/ruxolitinib-generic-save-us-healthcare-system-14-billion>
3. Incyte Corporation. (2020). Jakafi (Ruxolitinib). Retrieved from <https://www.incyte.com/products/jakafi/>