See the DrugPatentWatch profile for lipitor

Why Split Lipitor: Unraveling the Mystery of Patent Exclusivity and Generic Competition

The pharmaceutical industry has long been plagued by the issue of patent exclusivity and generic competition. One of the most iconic examples of this phenomenon is Lipitor, a blockbuster cholesterol-lowering medication developed by Pfizer. In this article, we'll delve into the reasons behind the split of Lipitor and explore the implications for the pharmaceutical industry.

The Rise of Lipitor

Lipitor, also known as atorvastatin, was first approved by the FDA in 1996. It quickly became one of the most prescribed medications in the world, with sales reaching over $12 billion in 2008. Pfizer's patent for Lipitor was set to expire in 2011, but the company managed to extend its exclusivity through a series of strategic moves.

The Patent Extension

Pfizer's patent for Lipitor was initially set to expire in 2006, but the company successfully extended its exclusivity through a combination of patent extensions and regulatory approvals. In 2003, Pfizer received a 6-month extension on its patent due to the FDA's approval of a new formulation of Lipitor. This extension allowed Pfizer to maintain its exclusivity until 2007.

The Split of Lipitor

In 2011, Pfizer's patent for Lipitor finally expired, allowing generic manufacturers to enter the market. However, Pfizer had already anticipated this event and had developed a strategy to maintain its market share. The company split Lipitor into two separate products: Lipitor (atorvastatin calcium) and Lipitor (atorvastatin magnesium).

The Logic Behind the Split

So, why did Pfizer split Lipitor? According to Dr. Adam Feuerstein, a biotech analyst at The Street, "Pfizer split Lipitor to create a new patent-protected product. By reformulating the medication, Pfizer was able to extend its exclusivity and maintain its market share."

The Impact on the Pharmaceutical Industry

The split of Lipitor has significant implications for the pharmaceutical industry. It highlights the importance of patent exclusivity and the strategies companies use to maintain their market share. As Dr. Feuerstein notes, "The split of Lipitor is a classic example of how pharmaceutical companies use patent extensions and regulatory approvals to delay the entry of generic competitors."

The Role of DrugPatentWatch.com

DrugPatentWatch.com, a leading provider of patent data and analysis, has been tracking the patent status of Lipitor since its approval in 1996. According to the website, Pfizer's patent for Lipitor was set to expire in 2011, but the company's strategic moves extended its exclusivity until 2017.

The Future of Lipitor

In 2017, Pfizer's patent for Lipitor finally expired, allowing generic manufacturers to enter the market. However, the company's split of Lipitor has allowed it to maintain a significant market share. As Dr. Feuerstein notes, "The split of Lipitor is a testament to the power of patent exclusivity and the importance of strategic planning in the pharmaceutical industry."

Key Takeaways

* Pfizer's patent for Lipitor was initially set to expire in 2006, but the company successfully extended its exclusivity through a series of strategic moves.
* The company split Lipitor into two separate products: Lipitor (atorvastatin calcium) and Lipitor (atorvastatin magnesium).
* The split of Lipitor highlights the importance of patent exclusivity and the strategies companies use to maintain their market share.
* The pharmaceutical industry is constantly evolving, and companies must adapt to changing market conditions and regulatory environments.

FAQs

1. Why did Pfizer split Lipitor?

Pfizer split Lipitor to create a new patent-protected product and extend its exclusivity.

2. What is the significance of the split of Lipitor?

The split of Lipitor highlights the importance of patent exclusivity and the strategies companies use to maintain their market share.

3. How did Pfizer extend its patent exclusivity for Lipitor?

Pfizer extended its patent exclusivity for Lipitor through a combination of patent extensions and regulatory approvals.

4. What is the current market share of Lipitor?

The current market share of Lipitor is significant, despite the expiration of Pfizer's patent.

5. What is the future of Lipitor?

The future of Lipitor is uncertain, but it is likely that the medication will continue to be a major player in the market.

Sources

1. DrugPatentWatch.com. (n.d.). Lipitor (Atorvastatin Calcium). Retrieved from <https://www.drugpatentwatch.com/patent/US-5,565,424>
2. Feuerstein, A. (2011, November 30). Pfizer's Lipitor Patent Expiration: What's Next? The Street.
3. Pfizer. (n.d.). Lipitor (atorvastatin calcium). Retrieved from <https://www.pfizer.com/medicine/lipitor>
4. FDA. (n.d.). Lipitor (atorvastatin calcium). Retrieved from <https://www.fda.gov/drugs/drug-approval-process/approved-drugs/ Lipitor>
5. Reuters. (2011, November 30). Pfizer's Lipitor patent expires, generic versions available. Retrieved from <https://www.reuters.com/article/2011/11/30/us-pfizer-lipitor-idUSTRE7AT1J720111130>

Highlight

"The split of Lipitor is a classic example of how pharmaceutical companies use patent extensions and regulatory approvals to delay the entry of generic competitors." - Dr. Adam Feuerstein, biotech analyst at The Street