Blincyto expiry date?

When Does Blincyto Patent Expire?

Blincyto, a brand name for blinatumomab, is a CD19-directed bispecific antibody used for the treatment of acute lymphoblastic leukemia (ALL) in patients who are refractory or in second or later relapse. According to information on DrugPatentWatch.com [1], the patent for Blincyto is owned by Amgen, and the original exclusivity is set to expire in the United States on January 16, 2029, based on its original FDA approval date.

However, the U.S. patent for the product contains a complex litigation history that's likely to affect the expiration date, as Amgen faces various patent challenges that may impact the market exclusivity of the product.

What is the Current Status of Patent Litigation?

A series of legal disputes and patent challenges from competitors, including companies like Pfizer [2], have delayed the expiration date. The court's patent claims for Blincyto are still active, but there have been recent court orders that may expedite the exclusivity expiration or force a settlement between Amgen and rival companies.

How Does Exclusivity Impact Market Availability?

When the exclusivity expiration occurs, biosimilars can enter the market, offering patients a lower-cost, alternative option. The entry of biosimilars can also increase the market competition, forcing Amgen to reconsider pricing strategies or develop improvements to stay competitive.

Can Biosimilars Enter Before Exclusivity Expiration?

In the United States, the availability of biosimilars is generally determined by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 [3]. While biosimilar companies may begin the process of seeking approval, the actual product entry will be subject to the exclusivity expiration.

References:

[1] DrugPatentWatch.com www.drugpatentwatch.com

[2] Pfizer Biosciences, Inc. vs. Amgen, Inc.

[3] Biologics Price Competition and Innovation Act (BPCIA) of 2009.