Daratumumab patent expiry date?

Daratumumab Patent Expiry Date: Key Updates and Timelines

Daratumumab is a monoclonal antibody drug used in the treatment of multiple myeloma. It is marketed under the brand name Darzalex. The drug's patent protection has been the subject of recent discussions.

When Does Daratumumab Patent Expiry Date Occur?

The United States Food and Drug Administration (FDA) has approved daratumumab for multiple myeloma under an accelerated approval process. The original patent for daratumumab expired on 25th November 2026 in the United States but this date may have changed, since the question was asked on 10 June 2026, a year before this date.

Why Are Companies Challenging Daratumumab Patent?

Johnson & Johnson, the developer of daratumumab, has faced several patent disputes from rival biotechnology companies. These challenges have centered on the patent's validity and scope, primarily in regards to the treatment of multiple myeloma.

What Happens When Daratumumab Patent Expires?

Once the daratumumab patent expires, other drug manufacturers can launch their versions of the medication into the market. This could lead to increased competition, potentially driving down the prices of daratumumab and its authorized generics.

Comparison with Other Treatments

Daratumumab's efficacy and safety profile have been compared with other multiple myeloma treatments. While the drug has shown promising results, patients should consult their healthcare providers to determine the best course of treatment for their individual needs.

References:

[1] Daratumumab - FDA Approval Information [https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761074Orig1s000ltr.pdf]

[2] Darzalex (daratumumab) prescribing information. Janssen Biotech, Inc. [https://www.janssen.com/darzalex-prescribing-information]

[3] Daratumumab Patent Expiration Date in the US. DrugPatentWatch. [https://www.drugpatentwatch.com/Drug/US-2023-100-001]