Expired rosuvastatin?

What happened to rosuvastatin after patent expiry?

On December 15, 2021 [1], the exclusivity for rosuvastatin, sold under the brand name Crestor, expired. This marked the end of a 20-year period of market exclusivity granted to AstraZeneca, the original patent holder. With this expiry, the first generic version of rosuvastatin was released into the US market.

Who produces generic rosuvastatin now?

As the patent has expired, multiple generic manufacturers have begun offering their versions of rosuvastatin, including [Dr. Reddy's, Sandoz (Novartis Generics), Mylan, and Lupin][2]. This increased competition has led to lower prices for the medication in the United States.

How does generic rosuvastatin compare with the original Crestor?

Generic rosuvastatin is expected to have the same efficacy and safety profile as the original Crestor [3]. This is because generic manufacturers must adhere to established manufacturing standards and test their products to ensure bioequivalence with the original medicine. Bioequivalence is the extent to which a generic drug is absorbed into the bloodstream and works in the same way as the reference product.

Are there any patient concerns or potential side effects?

As a generic version, rosuvastatin carries the same risk of side effects as Crestor, including muscle pain (myopathy) and liver damage. Patients taking rosuvastatin should continue monitoring their liver enzymes and speak with their healthcare provider if they experience any unusual symptoms.

Regulatory and market implications

The loss of market exclusivity for rosuvastatin has led to price competition, which may help make the cholesterol-lowering treatment more accessible and affordable for patients. It will also allow the market to be filled with biosimilars, although the US FDA may still be required to evaluate these biosimilars for approval [4].

References:
[1] https://www.drugpatentwatch.com/patent/US-7760022B1
[2] https://drugpatentwatch.com/patents/US7760022-B1#generic-entry
[3] https://www.nationwidechildrens.org/family-resources-education/health-library/rosuvastatin-oral-tablet
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7743415/