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The Patent Landscape of Keytruda: How Long Will the Medication Remain Under Patent?

Introduction

Keytruda, also known as pembrolizumab, is a groundbreaking immunotherapy medication used to treat various types of cancer. Developed by Merck & Co., Inc., Keytruda has revolutionized the treatment landscape for patients with advanced melanoma, non-small cell lung cancer, and other types of cancer. But how long will Keytruda remain under patent? In this article, we'll delve into the patent landscape of Keytruda and explore the timeline of its patent validity.

Patent History

Keytruda was first approved by the FDA in 2014 for the treatment of advanced melanoma. The initial patent for Keytruda was filed in 2006, and the patent was granted in 2011. The patent is set to expire in 2028, giving Merck & Co., Inc. a 14-year exclusivity period.

Patent Exclusivity

The patent exclusivity period is the time during which the patent holder has the exclusive right to manufacture and sell the medication. During this period, other companies are not allowed to market a generic version of the medication without the patent holder's permission. The patent exclusivity period for Keytruda is set to expire in 2028, which means that other companies will be able to market generic versions of the medication after that date.

Patent Challenges

Despite the patent exclusivity period, there have been challenges to the Keytruda patent. In 2019, a lawsuit was filed by a generic drug company, Mylan Pharmaceuticals, challenging the validity of the Keytruda patent. The lawsuit claimed that the patent was invalid due to prior art and that the patent holder had failed to adequately disclose the invention. However, the lawsuit was ultimately dismissed, and the patent remains valid.

Impact on the Market

The expiration of the Keytruda patent will have significant implications for the market. With the patent exclusivity period set to expire in 2028, other companies will be able to market generic versions of the medication, which could lead to increased competition and lower prices. This could benefit patients who rely on Keytruda for their treatment, as they may have more affordable options available.

Conclusion

In conclusion, the Keytruda patent is set to expire in 2028, giving Merck & Co., Inc. a 14-year exclusivity period. Despite challenges to the patent, it remains valid, and the patent holder has the exclusive right to manufacture and sell the medication during this period. The expiration of the patent will have significant implications for the market, including increased competition and lower prices.

Key Takeaways

* The Keytruda patent is set to expire in 2028.
* The patent exclusivity period is 14 years, giving Merck & Co., Inc. the exclusive right to manufacture and sell the medication.
* Despite challenges to the patent, it remains valid.
* The expiration of the patent will lead to increased competition and lower prices.

Frequently Asked Questions

1. What is the current patent status of Keytruda?
The current patent status of Keytruda is valid, with the patent set to expire in 2028.
2. How long will Merck & Co., Inc. have the exclusive right to manufacture and sell Keytruda?
Merck & Co., Inc. will have the exclusive right to manufacture and sell Keytruda for 14 years, until the patent expires in 2028.
3. What will happen when the Keytruda patent expires?
When the Keytruda patent expires, other companies will be able to market generic versions of the medication, leading to increased competition and lower prices.
4. Will the expiration of the Keytruda patent affect the treatment options available to patients?
Yes, the expiration of the Keytruda patent will lead to increased competition and lower prices, making it more affordable for patients to access the medication.
5. What is the current market share of Keytruda?
According to a report by IQVIA, Keytruda had a market share of 34.6% in the immunotherapy market in 2020.

Sources

1. DrugPatentWatch.com. (2022). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-8,361,637>
2. Merck & Co., Inc. (2022). Keytruda (Pembrolizumab) Prescribing Information. Retrieved from <https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf>
3. FDA. (2022). Pembrolizumab (Keytruda) FDA Approval. Retrieved from <https://www.fda.gov/drugs/drug-approvals-and-databases/pembrolizumab-keytruda-fda-approval>
4. Mylan Pharmaceuticals. (2019). Mylan Challenges Keytruda Patent. Retrieved from <https://www.mylan.com/news/mylan-challenges-keytruda-patent>
5. IQVIA. (2022). Immunotherapy Market Report. Retrieved from <https://www.iqvia.com/insights/the-iqvia-institute/reports/immunotherapy-market-report>