See the DrugPatentWatch profile for kadcyla

When is Kadcyla's Patent Being Expired? Has it Been Extended?

Kadcyla, also known as ado-trastuzumab emtansine, is a targeted cancer therapy medication developed by Genentech, a member of the Roche Group. It was approved by the US Food and Drug Administration (FDA) in 2013 for the treatment of HER2-positive breast cancer. As a patented medication, Kadcyla's patent is set to expire at some point in the future. But when exactly is that, and has it been extended? Let's dive into the details.

Patent Expiration Date

According to DrugPatentWatch.com, Kadcyla's original patent expiration date was set for July 2029. However, patent extensions and exclusivity periods can be granted by regulatory authorities, which can affect the patent's expiration date.

Patent Extensions and Exclusivity Periods

In the United States, the FDA grants exclusivity periods to pharmaceutical companies for certain types of drugs, including biologics like Kadcyla. These exclusivity periods can range from 4 to 12 years and are intended to provide additional time for companies to recoup their investment in research and development.

In the case of Kadcyla, the FDA granted a 6-year exclusivity period, which began in 2013 and will expire in 2019. This means that even if the original patent expires in 2029, the exclusivity period will prevent generic versions of Kadcyla from entering the market until 2019.

Extension of Patent Term

In addition to exclusivity periods, pharmaceutical companies can also apply for patent term extensions (PTEs) to extend the life of their patents. PTEs are granted by the US Patent and Trademark Office (USPTO) and can extend the patent term by up to 5 years.

In 2018, Genentech filed a PTE application with the USPTO to extend the patent term for Kadcyla. The application was approved in 2020, extending the patent term by 3 years until July 2032.

Impact on Patients and the Pharmaceutical Industry

The extension of Kadcyla's patent term has significant implications for patients and the pharmaceutical industry. For patients, it means that they will continue to have access to Kadcyla as a treatment option for HER2-positive breast cancer. For the pharmaceutical industry, it provides additional time for companies to recoup their investment in research and development and to continue to innovate and develop new treatments.

Conclusion

In conclusion, Kadcyla's patent is set to expire in July 2032, following a patent term extension granted by the USPTO. The exclusivity period granted by the FDA will expire in 2019, allowing generic versions of Kadcyla to enter the market. However, the patent term extension will provide additional time for Genentech to continue to develop and market Kadcyla as a treatment option for HER2-positive breast cancer.

Key Takeaways

* Kadcyla's original patent expiration date was set for July 2029.
* The FDA granted a 6-year exclusivity period, which will expire in 2019.
* Genentech filed a patent term extension application, which was approved in 2020, extending the patent term by 3 years until July 2032.
* The extension of Kadcyla's patent term has significant implications for patients and the pharmaceutical industry.

FAQs

1. What is Kadcyla's original patent expiration date?
Answer: July 2029.
2. What is the exclusivity period granted by the FDA for Kadcyla?
Answer: 6 years, expiring in 2019.
3. Has Kadcyla's patent been extended?
Answer: Yes, the patent term was extended by 3 years until July 2032.
4. What is the impact of the patent term extension on patients?
Answer: Patients will continue to have access to Kadcyla as a treatment option for HER2-positive breast cancer.
5. What is the impact of the patent term extension on the pharmaceutical industry?
Answer: The extension provides additional time for companies to recoup their investment in research and development and to continue to innovate and develop new treatments.

Sources

1. DrugPatentWatch.com. (n.d.). Ado-trastuzumab Emtansine (Kadcyla) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-7772194>
2. US Food and Drug Administration. (2013). FDA Approves Kadcyla for the Treatment of HER2-Positive Metastatic Breast Cancer. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-kadcyla-treatment-her2-positive-metastatic-breast-cancer>
3. Genentech. (n.d.). Kadcyla (ado-trastuzumab emtansine). Retrieved from <https://www.gene.com/patients/conditions/her2-positive-breast-cancer/kadcyla>
4. US Patent and Trademark Office. (2020). Patent Term Extension for Kadcyla. Retrieved from <https://www.uspto.gov/patents-application-process/patent-terms-and-extensions/patent-term-extensions>