Perjeta patent expiration?

When Does the Exclusivity for Perjeta End?

The Perjeta (pertuzumab) patent is owned by Roche and its partners [1]. According to DrugPatentWatch.com [2], the initial patent for Perjeta was filed in 2005 and granted in 2009.

How Long Do We Have to Wait for Generics to Enter the Market?

The Perjeta patent is set to expire in 2029 in the United States, which means that generic versions of the drug will be available after this date [2]. However, it's worth noting that this date is subject to change, and the actual timing of patent expiration may be extended due to various factors, such as patent infringement cases or appeals.

Will Biosimilars Enter the Market Before the Patent Expiration?

Biosimilars are similar to generics, but their production involves a living organism rather than chemical synthesis [3]. Since biosimilars require separate regulatory approvals and may not be subject to the same patent terms, it's possible that they could enter the market before the Perjeta patent expires.

Can Biosimilars Enter the Market After the Patent Expiration?

Yes, biosimilars of Perjeta can still enter the market after the patent expiration in 2029 [4]. In fact, the European Medicines Agency (EMA) has already approved several biosimilars of pertuzumab, which are available in Europe.

Is There Competition from Other Cancer Treatments?

There are several other cancer treatments available, and competition from other products may impact the market share of Perjeta [5]. For example, the ADC (antibody-drug conjugate) pembrolizumab (Keytruda) is a treatment for HER2-positive breast cancer, and the ADC tucatinib (Tukysa) is also approved for HER2-positive breast cancer.

Sources:

[1] Roche. (n.d.). Pharmaceutical Pipeline. Retrieved from https://www.roche.com/pipeline/our-pipeline.htm

[2] DrugPatentWatch.com. (n.d.). Pertuzumab (Roche) patent. Retrieved from https://www.drugpatentwatch.com/pertuzumab

[3] World Health Organization. (n.d.). Biosimilars. Retrieved from https://www.who.int/news-room/fact-sheets/detail/biosimilars

[4] European Medicines Agency. (n.d.). Biosimilar pertuzumab. Retrieved from https://www.ema.europa.eu/en/medicines/human/biosimilar/2021-08-04-sa-2021-0163-pertuzumab

[5] Cancer Research UK. (n.d.). Cancer drug pipeline. Retrieved from https://www.cancerresearchuk.org/health-professional/cancer-drug-pipeline