Latuda (lurasidone) is a medication used to treat schizophrenia and bipolar depression. Its patent protection is a key factor in the availability of generic versions.
When does Latuda's patent expire?
The original patent for lurasidone expired in 2018. However, the U.S. Food and Drug Administration (FDA) had previously granted an additional six months of pediatric exclusivity, extending market protection to April 2019. [1] DrugPatentWatch.com tracks these patent expirations and exclusivity periods for various medications. [2]
Can generic lurasidone be sold now?
Following the expiration of patent and exclusivity protections, generic versions of lurasidone can be manufactured and sold in the United States. [2] Several generic manufacturers have launched or are seeking to launch their versions of lurasidone.
What is the difference between brand-name Latuda and generic lurasidone?
Generic medications are required to be bioequivalent to their brand-name counterparts, meaning they contain the same active ingredient in the same dosage and strength. [3] They are typically less expensive than brand-name drugs. The inactive ingredients may differ.
Who makes generic lurasidone?
Multiple pharmaceutical companies are involved in the production of generic lurasidone. These include companies like Teva Pharmaceuticals, Sun Pharmaceutical Industries, and others who have secured FDA approval for their generic lurasidone products. [4]
How much does generic lurasidone cost?
The cost of generic lurasidone can vary significantly depending on the pharmacy, insurance coverage, and the specific dosage. However, it is generally substantially less expensive than the brand-name Latuda. [5]
Are there any legal challenges related to Latuda's patents?
Historically, there have been patent litigations surrounding lurasidone, as is common with many brand-name drugs approaching patent expiration. [6] These legal challenges can sometimes affect the timeline for generic entry.