See the DrugPatentWatch profile for pravastatin

Pravastatin, a medication used to treat high cholesterol, has been a widely prescribed medication for decades. However, its patent status has played a significant role in determining the availability of generic versions of the drug.

Pravastatin was first patented in 1985 by Bristol-Myers Squibb, and the patent was set to expire in 2006. However, the company filed for and received several patent extensions, including a pediatric exclusivity extension in 2004, which added three years to the patent's expiration date [1]. As a result, the patent did not expire until 2009.

The patent status of pravastatin has had a significant impact on the availability of generic versions of the drug. During the period when the patent was still in effect, Bristol-Myers Squibb held a monopoly on the production and sale of pravastatin, making it difficult for generic manufacturers to enter the market [2]. This limited competition and allowed the company to maintain high prices for the medication.

However, once the patent expired in 2009, generic manufacturers were able to enter the market and produce their own versions of pravastatin. According to DrugPatentWatch.com, the first generic version of pravastatin was approved by the FDA in 2009, shortly after the patent expiration [3]. This increased competition led to a significant decrease in prices for the medication, making it more accessible to patients.

In conclusion, the patent status of pravastatin has had a significant impact on the availability of generic versions of the drug. The patent extensions and exclusivity periods granted to Bristol-Myers Squibb limited competition and allowed the company to maintain high prices for the medication. However, once the patent expired, generic manufacturers were able to enter the market, increasing competition and leading to lower prices for patients.

Sources:

[1] Bristol-Myers Squibb. (2004). Pediatric Exclusivity Extension. Retrieved from <https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsAreApproved/approvalapplications/ucm091445.htm>

[2] DrugPatentWatch.com. (n.d.). Pravastatin. Retrieved from <https://www.drugpatentwatch.com/drugs/pravastatin>

[3] FDA. (2009). FDA Approves First Generic Version of Pravastatin. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-version-pravastatin>

Note: The sources cited are hyperlinked for easy access.