You’re using a public version of DrugChatter with 1 free searches available. Register to unlock more free searches per day. CREATE FREE ACCOUNT

Drug Chatter -- Get concise, cited information on drugs using AI GPT chat
Free Research Preview. DrugChatter may produce inaccurate information.

Ruxolitinib apotex anda filing date?



After reviewing the available information, I found that there is no specific filing date for Ruxolitinib Apotex, a pharmaceutical product that is a generic version of Jakafi, a treatment for myelofibrosis and polycythemia vera, blood disorders. However, I can provide you with some insights about Ruxolitinib Apotex and its related information.

Based on the information provided, Ruxolitinib Apotex is currently under review by Health Canada, as mentioned in the Canadian government's website [1]. This means that Apotex, a well-known Canadian pharmaceutical company, has submitted a generic version of Jakafi for approval in Canada. However, there is no information available regarding the filing date of Ruxolitinib Apotex.

Furthermore, the drug patent watch website [2] provides information about Jakafi's patent, which was granted in 2011 and will expire in 2030. This suggests that any generic version of Ruxolitinib, including Ruxolitinib Apotex, cannot be approved and sold in the United States until the patent expires. However, the patent's status and expiration date do not necessarily apply to other countries, such as Canada.

Lastly, the FDA has approved Ruxolitinib for the treatment of myelofibrosis and polycythemia vera [3]. However, the website does not provide any information about Ruxolitinib Apotex or its filing date.

In summary, while there is no specific filing date available for Ruxolitinib Apotex, it is currently under review by Health Canada. Additionally, Jakafi's patent will expire in 2030, which may affect the approval and availability of Ruxolitinib Apotex and other generic versions of Ruxolitinib.

Sources:

* [1] Government of Canada. (2021). Generic Submissions Under Review. Retrieved from <https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html>
* [2] Drug Patent Watch. (n.d.). Ruxolitinib. Retrieved from <https://www.drugpatentwatch.com/p/tradename/RUXOLITINIB>
* [3] U.S. Food and Drug Administration. (2021). Jakafi. Retrieved from <https://www.fda.gov/media/71502/download>



Follow-up:   When was Apotex's ruxolitinib ANDA filed? Has Apotex's ruxolitinib ANDA been approved? What is the filing date for Apotex's ruxolitinib ANDA? (Note: ANDA stands for Abbreviated New Drug Application)





DrugPatentWatch - Make Better Decisions
© thinkBiotech LLC 2004 - 2024. All rights reserved.