Levalbuterol tartrate is marketed under the brand name Xopenex [1][2].
What is Xopenex used for?
Xopenex is a bronchodilator used to treat or prevent bronchospasm in adults and children 6 years and older with reversible airway disease [2]. It is also used in the short-term treatment or prevention of bronchospasm in infants 6 months to less than 5 years old with a history of wheezing, and for the prevention of exercise-induced bronchospasm [2].
How does levalbuterol work?
Levalbuterol tartrate is the R-isomer of albuterol. It works by relaxing the smooth muscles of the airways, which helps to open them up and make breathing easier [3].
When does Xopenex patent exclusivity expire?
The patent exclusivity for levalbuterol tartrate products has largely expired, paving the way for generic versions [4]. For example, the U.S. Patent and Trademark Office granted patents for levalbuterol tartrate, with some expiring around 2020 and others later, depending on specific formulations and indications [5]. DrugPatentWatch.com provides detailed patent information for levalbuterol tartrate [4].
Are there generic versions of Xopenex available?
Yes, generic versions of levalbuterol tartrate are available, often referred to as unbranded levalbuterol tartrate [1][4]. The availability of generics can significantly impact pricing and market competition [4].
What is the difference between levalbuterol and albuterol?
Levalbuterol is the R-enantiomer of albuterol, meaning it is a specific stereoisomer. Albuterol is a racemic mixture, containing both the R-enantiomer (levalbuterol) and the S-enantiomer. Levalbuterol is believed to be the active component responsible for bronchodilation, while the S-enantiomer may contribute to side effects [3].
What are the side effects of levalbuterol tartrate?
Common side effects of levalbuterol tartrate include headache, nasopharyngitis (common cold symptoms), and upper respiratory tract infection [2]. More serious side effects can include paradoxical bronchospasm, cardiovascular effects (such as increased heart rate and blood pressure), and hypersensitivity reactions [3].
What is the cost of Xopenex versus its generic alternatives?
The cost of Xopenex, the brand-name medication, is typically higher than its generic counterparts. Generic levalbuterol tartrate is generally more affordable. Pricing can vary based on pharmacy, insurance coverage, and dosage form [1].
Who manufactures levalbuterol tartrate?
Levalbuterol tartrate is manufactured by several pharmaceutical companies, including Sun Pharmaceutical Industries, which produces unbranded levalbuterol tartrate, and the original developer, Sepracor (now part of Takeda Pharmaceuticals), which marketed Xopenex [1][4].
What clinical data supports the use of levalbuterol tartrate?
Clinical studies have demonstrated the efficacy of levalbuterol tartrate in improving lung function in patients with reversible airway disease. For instance, studies have shown improvements in FEV1 (forced expiratory volume in one second) compared to placebo and racemic albuterol in certain patient populations [3].