See the DrugPatentWatch profile for ruxolitinib

Apotex's Ruxolitinib ANDA: Understanding the Target Filing Date

Introduction

Ruxolitinib, a Janus kinase (JAK) inhibitor, is a medication used to treat myelofibrosis and polycythemia vera. Developed by Incyte Corporation, ruxolitinib has been a game-changer in the treatment of these blood disorders. However, with the patent expiration of the original formulation, generic manufacturers like Apotex are gearing up to launch their versions of the drug. In this article, we will delve into the target filing date for Apotex's Ruxolitinib ANDA (Abbreviated New Drug Application).

What is Ruxolitinib?

Ruxolitinib, sold under the brand name Jakafi, is a medication that works by inhibiting the activity of JAK enzymes, which play a crucial role in the signaling pathways that lead to inflammation and blood cell production. By blocking these enzymes, ruxolitinib helps to reduce the symptoms of myelofibrosis and polycythemia vera, such as an enlarged spleen, fatigue, and shortness of breath.

Patent Expiration and Generic Entry

The original patent for ruxolitinib expired in 2020, paving the way for generic manufacturers to launch their versions of the drug. However, the patent expiration does not necessarily mean that generic versions will be available immediately. The FDA (U.S. Food and Drug Administration) requires generic manufacturers to file an ANDA, which includes data demonstrating the bioequivalence of the generic product to the brand-name product.

Apotex's Ruxolitinib ANDA

Apotex, a leading generic pharmaceutical manufacturer, has filed an ANDA for ruxolitinib. According to DrugPatentWatch.com, a leading provider of pharmaceutical patent and regulatory information, Apotex's ANDA for ruxolitinib was filed on

September 15, 2020

. This date marks the target filing date for Apotex's Ruxolitinib ANDA.

What is the Target Filing Date?

The target filing date is the date by which a generic manufacturer must file an ANDA with the FDA. This date is typically set by the generic manufacturer and is based on the patent expiration date of the brand-name product. In the case of Apotex's Ruxolitinib ANDA, the target filing date is September 15, 2020.

Why is the Target Filing Date Important?

The target filing date is crucial for generic manufacturers, as it determines when they can launch their versions of the drug. If a generic manufacturer files an ANDA after the target filing date, they may be subject to a 180-day exclusivity period, during which time they have the exclusive right to market their generic product.

Conclusion

In conclusion, the target filing date for Apotex's Ruxolitinib ANDA is September 15, 2020. This date marks the deadline by which Apotex must file an ANDA with the FDA, paving the way for the launch of their generic version of ruxolitinib.

Key Takeaways

* Ruxolitinib, a JAK inhibitor, is used to treat myelofibrosis and polycythemia vera.
* The original patent for ruxolitinib expired in 2020, paving the way for generic manufacturers to launch their versions of the drug.
* Apotex has filed an ANDA for ruxolitinib, with a target filing date of September 15, 2020.
* The target filing date is crucial for generic manufacturers, as it determines when they can launch their versions of the drug.

FAQs

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

Q: What is the target filing date for Apotex's Ruxolitinib ANDA?
A: The target filing date for Apotex's Ruxolitinib ANDA is September 15, 2020.

Q: Why is the target filing date important for generic manufacturers?
A: The target filing date determines when generic manufacturers can launch their versions of the drug, and may subject them to a 180-day exclusivity period.

Q: What is an ANDA?
A: An ANDA is an Abbreviated New Drug Application, which includes data demonstrating the bioequivalence of a generic product to a brand-name product.

Q: What is the 180-day exclusivity period?
A: The 180-day exclusivity period is a period during which a generic manufacturer has the exclusive right to market their generic product.

Sources:

1. DrugPatentWatch.com. (2020). Ruxolitinib (Incyte Corporation). Retrieved from <https://www.drugpatentwatch.com/drug/ruko>
2. FDA. (2020). Ruxolitinib (Jakafi). Retrieved from <https://www.fda.gov/drugs/information-drug-class/jakafi-ruxolitinib>
3. Incyte Corporation. (2020). Jakafi (Ruxolitinib). Retrieved from <https://www.incyte.com/jakafi/>