See the DrugPatentWatch profile for lipitor

When Will Lipitor Be Available: Understanding the Patent Expiration and Generic Options

Lipitor, a popular cholesterol-lowering medication, has been a staple in many people's medicine cabinets for years. However, its patent expiration has raised questions about when it will be available as a generic option. In this article, we'll delve into the patent expiration timeline, the current generic landscape, and what it means for patients.

Patent Expiration Timeline

Lipitor, also known as atorvastatin, was first approved by the FDA in 1996. The original patent for Lipitor was set to expire in 2011, but Pfizer, the manufacturer, extended the patent through a series of patent extensions. The patent finally expired on November 10, 2011.

Generic Options

Although the patent has expired, generic versions of Lipitor have been available in the market since 2012. Several generic manufacturers, including Teva Pharmaceuticals, Ranbaxy Laboratories, and Mylan Pharmaceuticals, have received FDA approval to market their own versions of the drug.

Current Generic Landscape

Today, there are numerous generic options available for Lipitor, including:

* Atorvastatin calcium tablets, 10mg, 20mg, 40mg, and 80mg, manufactured by Teva Pharmaceuticals
* Atorvastatin calcium tablets, 10mg, 20mg, 40mg, and 80mg, manufactured by Ranbaxy Laboratories
* Atorvastatin calcium tablets, 10mg, 20mg, 40mg, and 80mg, manufactured by Mylan Pharmaceuticals
* Atorvastatin calcium tablets, 10mg, 20mg, 40mg, and 80mg, manufactured by Dr. Reddy's Laboratories

Why the Delay in Generic Availability?

Despite the patent expiration, it took several years for generic versions of Lipitor to become available. There are a few reasons for this delay:

* Patent challenges: Pfizer, the original manufacturer, filed patent infringement lawsuits against several generic manufacturers, including Teva Pharmaceuticals and Ranbaxy Laboratories. These lawsuits delayed the entry of generic versions into the market.
* FDA approval process: The FDA approval process for generic drugs is rigorous and time-consuming. Generic manufacturers must demonstrate bioequivalence to the original branded drug, which can take several years.
* Manufacturing and distribution: Generic manufacturers must establish manufacturing and distribution capabilities, which can take time.

What Does This Mean for Patients?

The availability of generic Lipitor options has made the medication more affordable for patients. According to DrugPatentWatch.com, the average wholesale price (AWP) for generic Lipitor is significantly lower than the AWP for the branded version.

* Cost savings: Patients can expect to save up to 90% on their Lipitor prescription costs by switching to a generic option.
* Increased accessibility: The availability of generic Lipitor options has made the medication more accessible to patients who may have previously been unable to afford it.

Conclusion

Lipitor, a popular cholesterol-lowering medication, is now available as a generic option. Although the patent expiration timeline was delayed due to patent challenges and the FDA approval process, the availability of generic options has made the medication more affordable for patients. As the generic market continues to evolve, patients can expect to see even more options become available.

Key Takeaways

* Lipitor's patent expired in 2011, but generic options became available in 2012.
* Several generic manufacturers have received FDA approval to market their own versions of the drug.
* The availability of generic Lipitor options has made the medication more affordable for patients.
* Patients can expect to save up to 90% on their Lipitor prescription costs by switching to a generic option.

FAQs

1. When will Lipitor be available as a generic option?
Lipitor's patent expired in 2011, and generic options have been available since 2012.
2. Who manufactures generic Lipitor?
Several generic manufacturers, including Teva Pharmaceuticals, Ranbaxy Laboratories, Mylan Pharmaceuticals, and Dr. Reddy's Laboratories, manufacture generic versions of Lipitor.
3. How much can I save by switching to a generic option?
Patients can expect to save up to 90% on their Lipitor prescription costs by switching to a generic option.
4. Is generic Lipitor as effective as the branded version?
Yes, generic Lipitor is bioequivalent to the branded version and has the same efficacy and safety profile.
5. Can I switch to a generic option if I'm currently taking the branded version?
Yes, you can switch to a generic option if you're currently taking the branded version. However, it's recommended that you consult with your healthcare provider before making any changes to your medication regimen.

Cited Sources

1. DrugPatentWatch.com. (n.d.). Lipitor (Atorvastatin Calcium) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration-dates/atorvastatin-calcium-lipitor>
2. FDA. (2011). FDA Approves Generic Version of Lipitor. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-generic-version-lipitor>
3. Pfizer. (n.d.). Lipitor Product Information. Retrieved from <https://www.pfizer.com/products/lipitor>