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.

When is apotex s ruxolitinib anda filing expected in the us?



According to the information provided, there is an expected filing for Apotex's ruxolitinib ANDAs (Abbreviated New Drug Applications) in the US. However, the exact date for this filing is not specified in the available information.

Ruxolitinib is a drug that is used to treat certain types of blood cancer, such as myelofibrosis and polycythemia vera. It is a Janus kinase (JAK) inhibitor that works by blocking the action of certain enzymes in the body that can lead to the overproduction of blood cells.

Apotex is a Canadian pharmaceutical company that specializes in the development, manufacturing, and distribution of high-quality, affordable medicines. The company has a strong track record of bringing generic versions of drugs to market, which can help increase access to important medications and reduce healthcare costs.

According to DrugPatentWatch.com, ruxolitinib is currently under patent protection in the US until 2027 [1]. However, it is possible for generic versions of the drug to be approved and enter the market before the patent expiration date, as has happened with other drugs in the past.

It is worth noting that the approval and launch of a generic drug can take some time after the filing of an ANDA. The process typically involves a review by the US Food and Drug Administration (FDA) to ensure that the generic drug is safe and effective, as well as bioequivalent to the brand-name drug.

In summary, while there is an expected filing for Apotex's ruxolitinib ANDAs in the US, the exact date for this filing is not specified in the available information. The drug is currently under patent protection in the US until 2027, but it is possible for generic versions of the drug to be approved and enter the market before that date.

Sources:

1. DrugPatentWatch.com. (n.d.). Ruxolitinib (Jakafi) Drug Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/drugs/ruxolitinib-jakafi.html>



Follow-up:   When will Apotex's ruxolitinib ANDA be filed in the US? Has Apotex announced a timeline for ruxolitinib filing in US? Is there an expected date for Apotex's ruxolitinib US submission?





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