Background: Originator drug manufacturers use several strategies to delay generic competition in the USA, but it remains unclear whether this results in longer market exclusivity compared to other countries.
Objectives: We sought to understand how drug market exclusivity lengths vary between the USA and two comparable countries.
Methods: We focused on drugs approved within 2 years of each other in the USA, France, and Australia from 1995 to 2005, and we compared the lengths of exclusivity from marketing approval through first generic competition or June 2023 using Kaplan-Meier analyses.
Results: Among 165 drugs in common between the USA and France, the median length of exclusivity was slightly longer in France (15.0 years, interquartile range [IQR]: 13.0-19.6) than the USA (14.5 years, IQR: 11.7-17.6). Among 100 drugs in common between the USA and Australia, the median length of exclusivity was longer in Australia (16.3 years, IQR: 13.9-22.4) than in the USA (14.4 years, IQR: 12.0-17.1).
Conclusions: Market exclusivity lengths in the USA are not longer than in France and Australia. Potential reasons include the larger US market and incentives that offer transient high generic drug prices in the USA for manufacturers that successfully challenge originator market exclusivity.
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http://dx.doi.org/10.1007/s40290-024-00527-w | DOI Listing |
JAMA Netw Open
December 2024
School of Pharmacy, University of Maryland, Baltimore.
Importance: Initiating effective therapy early is associated with improved survival among patients hospitalized with gram-negative bloodstream infections; furthermore, providing early phenotype-desirable antimicrobial therapy (PDAT; defined as receipt of a β-lactam antibiotic with the narrowest spectrum of activity to effectively treat the pathogen's phenotype) is crucial for antimicrobial stewardship. However, the timing of targeted therapy among patients hospitalized with gram-negative bloodstream infections is not well understood.
Objective: To compare the clinical outcomes between patients who were hospitalized with Enterobacterales bloodstream infections receiving early vs delayed PDAT.
bioRxiv
December 2024
Lester and Sue Smith Breast Center and Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX 77030, USA.
Combination chemotherapy remains essential for clinical management of triple-negative breast cancer (TNBC). Consequently, responses to individual agents cannot be easily delineated at the single patient level, even though some patients might not require all drugs in the combination. Herein, we conduct multi-omic analyses of orthotopic TNBC patient-derived xenografts (PDXs) treated with single agent carboplatin, docetaxel, or the combination.
View Article and Find Full Text PDFMol Pharm
December 2024
School of Pharmacy, University College Cork, College Road, Cork T12 K8AF, Ireland.
Advanced predictive modeling approaches have harnessed data to fuel important innovations at all stages of drug development. However, the need for a machine-readable drug product library which consolidates many aspects of formulation design and performance remains largely unmet. This study presents a scripted, reproducible approach to database curation and explores its potential to streamline oral medicine development.
View Article and Find Full Text PDFJ Vet Med Sci
December 2024
Department of Immunopathology and Microbiology, College of Veterinary Medicine and Biomedical Sciences, Cavite State University.
Parasitic diseases pose a threat to fisheries, negatively affecting the livelihood and food security of billions of people worldwide. Among these, parasitic isopods of fish are not well documented and studied. Thus, we examined the buccal cavity of 385 randomly selected saltwater fishes sold in a fish market in Naic, Cavite, Philippines.
View Article and Find Full Text PDFNeurocirugia (Astur : Engl Ed)
December 2024
Servicio de Neurocirugía, Hospital Universitario La Paz, Madrid, Spain.
Introduction: The global incidence of spinal pathology is increasing due to the progressive aging of the population and increased life expectancy. Vertebral fixation with transpedicular screws is the most commonly used technique in unstable or potentially unstable pathologies. There are different implantation methods, the most recently developed being implantation guided by robotic navigation.
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