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Yervoy Patent Expiration: Understanding the Last Date of Patent Protection

Introduction

Yervoy, also known as ipilimumab, is a monoclonal antibody used to treat various types of cancer, including melanoma and lung cancer. Developed by Bristol-Myers Squibb (BMS), Yervoy has been a game-changer in the field of oncology, offering patients a new hope for survival. However, like all patented medications, Yervoy's patent protection is set to expire, raising questions about the future of the drug. In this article, we will explore the last date of patent protection for Yervoy and what it means for patients and the pharmaceutical industry.

Patent Protection for Yervoy

Yervoy's patent protection is based on its unique chemical structure and method of use. The original patent for Yervoy was filed in 2004 and granted in 2006. However, patent protection is not a single event, but rather a series of events that occur over time. In the United States, patent protection is typically granted for 20 years from the date of filing, but it can be extended through various mechanisms, such as patent term adjustments and patent term extensions.

Patent Expiration Date for Yervoy

According to DrugPatentWatch.com, a leading provider of patent data and analytics, the patent expiration date for Yervoy is September 16, 2024. This date marks the end of the patent protection for Yervoy in the United States. However, it's essential to note that patent protection is not the only form of intellectual property protection for pharmaceuticals. Other forms of protection, such as orphan drug exclusivity and data exclusivity, may still be in effect.

Data Exclusivity for Yervoy

Data exclusivity is a type of protection that prevents generic manufacturers from relying on the original sponsor's clinical trial data to support their own marketing applications. In the case of Yervoy, data exclusivity is set to expire on September 16, 2024, the same date as the patent expiration. However, data exclusivity can be extended through various mechanisms, such as patent term extensions and pediatric exclusivity.

Orphan Drug Exclusivity for Yervoy

Orphan drug exclusivity is a type of protection that provides a seven-year market exclusivity for drugs that treat rare diseases. Yervoy was granted orphan drug exclusivity in 2011 for the treatment of melanoma, which is a rare disease. However, orphan drug exclusivity is not directly related to patent protection and may still be in effect even after the patent expiration date.

What Does Patent Expiration Mean for Yervoy?

The patent expiration date for Yervoy marks the end of the patent protection for the drug. This means that generic manufacturers can begin to market their own versions of Yervoy, which may be cheaper and more accessible to patients. However, it's essential to note that patent expiration does not necessarily mean that the original sponsor, BMS, will lose its market share. The company may still have other forms of protection, such as data exclusivity and orphan drug exclusivity, that can help maintain its market position.

Impact on Patients

The patent expiration date for Yervoy may have a significant impact on patients who rely on the drug for their treatment. Generic versions of Yervoy may be cheaper and more accessible, which can improve patient outcomes and increase access to care. However, it's essential to note that generic versions of Yervoy may not be identical to the original drug, and patients may need to work with their healthcare providers to ensure a smooth transition.

Impact on the Pharmaceutical Industry

The patent expiration date for Yervoy marks a significant shift in the pharmaceutical industry. The expiration of patent protection for Yervoy will create a new market opportunity for generic manufacturers, which can help increase competition and drive down prices. However, it's essential to note that the expiration of patent protection may also lead to a decrease in research and development investment, as companies may be less inclined to invest in new products that may not be protected by patent.

Conclusion

The patent expiration date for Yervoy marks the end of the patent protection for the drug. While this may create new market opportunities for generic manufacturers, it's essential to note that other forms of protection, such as data exclusivity and orphan drug exclusivity, may still be in effect. Patients and the pharmaceutical industry must be prepared for the changes that will occur as a result of patent expiration.

Key Takeaways

* The patent expiration date for Yervoy is September 16, 2024.
* Patent expiration marks the end of patent protection for Yervoy.
* Data exclusivity and orphan drug exclusivity may still be in effect after patent expiration.
* Generic versions of Yervoy may be cheaper and more accessible to patients.
* The patent expiration date for Yervoy may have a significant impact on the pharmaceutical industry.

Frequently Asked Questions

Q: What is the patent expiration date for Yervoy?
A: The patent expiration date for Yervoy is September 16, 2024.

Q: What does patent expiration mean for Yervoy?
A: Patent expiration marks the end of patent protection for Yervoy, which may create new market opportunities for generic manufacturers.

Q: Will the original sponsor, BMS, lose its market share after patent expiration?
A: No, BMS may still have other forms of protection, such as data exclusivity and orphan drug exclusivity, that can help maintain its market position.

Q: What impact will patent expiration have on patients?
A: Patent expiration may lead to cheaper and more accessible generic versions of Yervoy, which can improve patient outcomes and increase access to care.

Q: What impact will patent expiration have on the pharmaceutical industry?
A: Patent expiration may create a new market opportunity for generic manufacturers, but it may also lead to a decrease in research and development investment.

Sources:

1. DrugPatentWatch.com. (n.d.). Yervoy (ipilimumab) Patent Expiration Date. Retrieved from <https://www.drugpatentwatch.com/patent/US-2004-0123411>
2. Bristol-Myers Squibb. (n.d.). Yervoy (ipilimumab). Retrieved from <https://www.bms.com/our-story/our-products/yervoy.html>
3. FDA. (n.d.). Orphan Drug Exclusivity. Retrieved from <https://www.fda.gov/drugs/development-approval-process-drugs/orphan-drug-exclusivity>
4. FDA. (n.d.). Data Exclusivity. Retrieved from <https://www.fda.gov/drugs/development-approval-process-drugs/data-exclusivity>