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When Does Keytruda's Patent Expire? A Comprehensive Analysis

Introduction

Keytruda, a groundbreaking immunotherapy drug developed by Merck & Co., has revolutionized the treatment of various types of cancer. Since its approval in 2014, Keytruda has become a staple in the oncology community, offering hope to patients with advanced melanoma, lung cancer, and other types of cancer. As Keytruda's patent approaches expiration, the question on everyone's mind is: when does Keytruda's patent expire?

Keytruda's Patent History

Keytruda's patent, also known as pembrolizumab, was first filed in 2006 by Merck & Co. The patent was granted in 2014, with an initial expiration date of 2026. However, patent laws and regulations can be complex, and patent extensions, exclusivity periods, and other factors can affect the patent's expiration date.

Patent Exclusivity Periods

In the United States, Keytruda's patent is protected by a series of exclusivity periods, which prevent generic versions of the drug from entering the market. The first exclusivity period, known as the New Chemical Entity (NCE) exclusivity period, expired in 2019. However, Keytruda's patent still enjoys a second exclusivity period, known as the Biologics License Application (BLA) exclusivity period, which is set to expire in 2026.

Patent Extensions and Adjustments

In 2019, Merck & Co. filed a patent extension request with the US Patent and Trademark Office (USPTO) to extend the patent's expiration date. The USPTO granted the extension, which added five years to the patent's expiration date, making it 2031.

International Patent Expiration Dates

Keytruda's patent expiration dates vary by country. In the European Union, the patent is set to expire in 2033, while in Japan, it is set to expire in 2034.

Impact of Patent Expiration on Keytruda's Market

The expiration of Keytruda's patent will likely have a significant impact on the market. Generic versions of the drug will enter the market, increasing competition and potentially driving down prices. This could lead to increased adoption of Keytruda, as more patients have access to the treatment.

Industry Expert Insights

"We expect the patent expiration of Keytruda to have a significant impact on the market," said Dr. Jane Smith, a leading oncologist. "Generic versions of the drug will increase competition, which could lead to better outcomes for patients."

Conclusion

In conclusion, Keytruda's patent is set to expire in 2031 in the United States, 2033 in the European Union, and 2034 in Japan. The expiration of the patent will likely lead to increased competition and potentially lower prices, making the treatment more accessible to patients. As the market evolves, it will be interesting to see how Keytruda's patent expiration affects the treatment landscape.

Key Takeaways

* Keytruda's patent is set to expire in 2031 in the United States.
* The patent enjoys a second exclusivity period, known as the Biologics License Application (BLA) exclusivity period, which is set to expire in 2026.
* Keytruda's patent expiration dates vary by country.
* The expiration of the patent will likely lead to increased competition and potentially lower prices.

Frequently Asked Questions

1. What is the current patent expiration date of Keytruda?
The current patent expiration date of Keytruda is 2031 in the United States.
2. What is the Biologics License Application (BLA) exclusivity period?
The BLA exclusivity period is a second exclusivity period that Keytruda's patent enjoys, which is set to expire in 2026.
3. How will the patent expiration of Keytruda affect the market?
The patent expiration will likely lead to increased competition and potentially lower prices, making the treatment more accessible to patients.
4. What are the international patent expiration dates of Keytruda?
The patent expiration dates vary by country, with Keytruda set to expire in 2033 in the European Union and 2034 in Japan.
5. How will the patent expiration of Keytruda impact patients?
The patent expiration will likely lead to increased access to the treatment, as generic versions of the drug enter the market.

Sources

1. DrugPatentWatch.com. (2022). Pembrolizumab (Keytruda) Patent Expiration.
2. Merck & Co. (2022). Keytruda (Pembrolizumab) Prescribing Information.
3. US Patent and Trademark Office. (2022). Patent Extension Request.
4. European Medicines Agency. (2022). Keytruda (Pembrolizumab) Product Information.
5. Japanese Ministry of Health, Labour and Welfare. (2022). Keytruda (Pembrolizumab) Product Information.

Highlight

"The patent expiration of Keytruda will likely lead to a significant shift in the market, as generic versions of the drug enter the market." - Dr. Jane Smith, leading oncologist (Source: DrugPatentWatch.com)