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When did apotex submit ruxolitinib anda in usa?

See the DrugPatentWatch profile for ruxolitinib

When Did Apotex Submit Ruxolitinib ANDA in the USA?

Ruxolitinib, a Janus kinase (JAK) inhibitor, is a medication used to treat patients with myelofibrosis, a type of bone marrow cancer. Apotex, a Canadian pharmaceutical company, has been working to develop a generic version of Ruxolitinib, marketed as Jakafi by Incyte Corporation. In this article, we will explore when Apotex submitted its Abbreviated New Drug Application (ANDA) for Ruxolitinib in the United States.

What is Ruxolitinib?

Ruxolitinib is a JAK inhibitor that works by blocking the activity of JAK1 and JAK2 enzymes, which are involved in the signaling pathways that contribute to the development and progression of myelofibrosis. By inhibiting these enzymes, Ruxolitinib helps to reduce the symptoms associated with myelofibrosis, such as splenomegaly, anemia, and constitutional symptoms.

Patent Status of Ruxolitinib

Ruxolitinib is protected by a patent that was filed in 2006 and granted in 2011. The patent is set to expire in 2026, which means that generic versions of the medication can be developed and marketed after that date. Apotex, being a generic pharmaceutical company, is working to develop a generic version of Ruxolitinib to capitalize on the patent expiration.

ANDA Submission by Apotex

According to DrugPatentWatch.com, Apotex submitted its ANDA for Ruxolitinib to the US Food and Drug Administration (FDA) in August 2020. The ANDA is a request for permission to market a generic version of a branded drug, and it includes detailed information about the generic drug, including its manufacturing process, quality control measures, and bioequivalence studies.

Why is Apotex Developing a Generic Version of Ruxolitinib?

Apotex is developing a generic version of Ruxolitinib to provide a more affordable treatment option for patients with myelofibrosis. Ruxolitinib is a costly medication, and the generic version is expected to be priced lower than the branded version. This will make it more accessible to patients who may not have been able to afford the medication otherwise.

What are the Benefits of a Generic Version of Ruxolitinib?

A generic version of Ruxolitinib will provide several benefits to patients and the healthcare system. These benefits include:

* Cost savings: Generic medications are typically priced lower than branded medications, which means that patients will pay less for their treatment.
* Increased access: Generic medications are more widely available, which means that patients will have greater access to the medication.
* Improved health outcomes: By providing a more affordable treatment option, generic medications can improve health outcomes for patients with myelofibrosis.

Conclusion

Apotex submitted its ANDA for Ruxolitinib to the FDA in August 2020. The generic version of the medication is expected to be priced lower than the branded version, making it more accessible to patients with myelofibrosis. By developing a generic version of Ruxolitinib, Apotex is providing a more affordable treatment option for patients and improving health outcomes.

Key Takeaways

* Apotex submitted its ANDA for Ruxolitinib to the FDA in August 2020.
* The generic version of Ruxolitinib is expected to be priced lower than the branded version.
* A generic version of Ruxolitinib will provide cost savings, increased access, and improved health outcomes for patients with myelofibrosis.

FAQs

1. What is Ruxolitinib?
Ruxolitinib is a Janus kinase (JAK) inhibitor used to treat patients with myelofibrosis.
2. Who is developing a generic version of Ruxolitinib?
Apotex, a Canadian pharmaceutical company, is developing a generic version of Ruxolitinib.
3. When did Apotex submit its ANDA for Ruxolitinib?
Apotex submitted its ANDA for Ruxolitinib to the FDA in August 2020.
4. What are the benefits of a generic version of Ruxolitinib?
The benefits of a generic version of Ruxolitinib include cost savings, increased access, and improved health outcomes for patients with myelofibrosis.
5. When will the generic version of Ruxolitinib be available?
The generic version of Ruxolitinib is expected to be available after the patent expiration date of 2026.

Cited Sources

1. DrugPatentWatch.com. (2020). Ruxolitinib (Jakafi) Patent Expiration Date. Retrieved from <https://www.drugpatentwatch.com/patent-expiration-date/Ruxolitinib-Jakafi>
2. Incyte Corporation. (n.d.). Jakafi (Ruxolitinib) Prescribing Information. Retrieved from <https://www.incyte.com/content/dam/incyte/pdfs/Jakafi-Prescribing-Information.pdf>



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