1、JULY202 5Trends in Drug Shortages and ANDA Approvals in the U.S.RESEARCH BRIEFTable of Contents2025 IQVIA and its affiliates.All reproduction rights,quotations,broadcasting,publications reserved.No part of this publication may be reproduced or transmitted in any form or by any means,electronic or me

2、chanical,including photocopy,recording,or any information storage and retrieval system,without express written consent of IQVIA and the IQVIA Institute.REFERENCING THIS REPORTPlease use this format when referencing content from this report:Source:IQVIA Institute for Human Data Science.Trends in Drug

3、 Shortages and ANDA Approvals in the U.S.July 2025.Available from www.iqviainstitute.orgThis research brief has been developed independently by the IQVIA Institute for Human Data Science.Funding for this research brief has been provided by the Healthcare Distribution Alliance.Trends in Drug Shortage

4、s and ANDA Approvals in the U.S.Overview 1Characteristics of drug shortages 2Trends in the launch of ANDA approved generics and drug shortages 5Discussion 11Definitions12Notes on sources 13References 14About the authors 15About the Institute 16Overview The U.S.healthcare system continues to face per

5、sistent drug shortages,particularly affecting generic medications and sterile injectables.As of June 2024,the FDA reported 102 active shortages,with over half lasting more than two years.These shortages are most prevalent in pain management and oncology,with injectables comprising the majority.Gener

6、ic drugs,which are essential for affordable healthcare access,account for 84%of these shortages.Drug shortages stem from both supply and demand-side issues.On the supply side,manufacturing complexities especially for sterile injectables create long lead times and high production costs.Market dynamic