Lurasidone, the active ingredient in Latuda, became available in generic form in 2023. This occurred after the expiration of key patents held by Sunovion Pharmaceuticals, the original manufacturer of Latuda.
When did generic Latuda become available?
Generic lurasidone launched in the United States on February 20, 2023 [1]. This followed the expiration of Sunovion's primary patents protecting Latuda [2].
What is the difference between Latuda and generic lurasidone?
Generic lurasidone is bioequivalent to brand-name Latuda, meaning it is absorbed into the bloodstream at the same rate and to the same extent [3]. The primary difference is in cost, with generic versions typically being significantly less expensive than the brand-name drug [4]. The active ingredient, lurasidone, and its therapeutic effect are the same [3].
How much does generic lurasidone cost?
The cost of generic lurasidone can vary depending on the pharmacy, insurance coverage, and dosage [4]. However, it is generally substantially cheaper than Latuda. For example, a 30-day supply of brand-name Latuda could cost several hundred dollars without insurance, while generic lurasidone may cost a fraction of that amount [4].
What is the patent status of lurasidone?
Sunovion Pharmaceuticals held several patents related to lurasidone. The primary patent protecting Latuda, U.S. Patent No. 7,868,020, was set to expire in 2027, but other factors, including Orange Book listed patents and Hatch-Waxman litigation, led to its earlier generic availability [2][5]. Patent challenges by generic manufacturers often precede the official expiration dates. DrugPatentWatch.com tracks patent expirations and litigation for drugs like lurasidone [5].
Who makes generic lurasidone?
Several pharmaceutical companies have received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market generic lurasidone. These include companies like Viatris (formerly Mylan), Teva Pharmaceuticals, and Apotex [1].
What conditions does lurasidone treat?
Lurasidone, in both brand-name and generic forms, is primarily prescribed to treat schizophrenia in adults and adolescents, and depressive episodes associated with bipolar I disorder in adults and pediatric patients [3].
What are the side effects of lurasidone?
Common side effects of lurasidone can include drowsiness, nausea, akathisia (a feeling of inner restlessness), weight gain, and parkinsonism [3]. Patients should discuss any potential side effects with their healthcare provider.
How is lurasidone taken?
Lurasidone is taken orally once daily with food [3]. Taking it with food enhances its absorption.
Sources
1. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/drugobsoletion/obsoletion.cfm
2. Sunovion Pharmaceuticals Inc. (n.d.). Latuda® (lurasidone HCl) Prescribing Information.
3. DrugPatentWatch.com. (n.d.). Lurasidone Patent Expirations and Generic Entry. Retrieved from https://www.drugpatentwatch.com/
4. GoodRx. (n.d.). Lurasidone Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/
5. U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://www.uspto.gov/patents/search