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M 06: Analysis of Off-Patent Pharmaceutical Price Increases: 2013-2016

Poster Presenter

      Reshma Devi Lakhram

      • Student
      • Touro College of Pharmacy
        United States


The objective of this study is to investigate the magnitude of price increases for off-patent pharmaceuticals over the last 3 years. Various proposed regulatory and legislative solutions are summarized and evaluated.


Price changes from 2013-2016 for off-patent drugs were accessed from Micromedex and RedBook databases. The increases were classified and analyzed for their potential impact on patient care. Various regulatory and legislative solutions proposed to diminish this evolving problem are presented.


The emerging issue of off-patent pharmaceutical price hikes has been a major concern headlining the media and causing reasonable debates in Congress. The price increases of 266 off-patent pharmaceuticals were evaluated. Since 2013, increases by at least one manufacturer were noted in 151/266 (57%). Increases of > 200% since 2013 were noted in 88/266 (33%). Several critical care medications such as digoxin, sodium nitroprusside and isoproterenol had increases in excess of 200%. This recent change has negatively impacted many hospitals that use these drugs on a daily basis. Several categories of medications were involved in a large number of increases: powders, solutions, injectable of diuretics, antibacterial, ACE inhibitors and anesthetic drugs. Our findings showed, that the same manufacturers distributed most of the price-increased drugs. Approximately, 25/266 (9.4%) of these drugs were sole source generic drugs, meaning there was no price competition at all. A notable example is ethacrynic acid, which experienced a percent change 14 times by its sole manufacturer within a short span of 2½ years. In addition, changes in acquisition costs for some of the generic off-patent drugs like Captopril, doxazosin and fluconazole were reviewed and analyzed with significant percent changes in National Average Drug Acquisition Cost (NADAC) exceeding 1000% within a year period. We examined several possible regulatory and legislative alternatives currently under consideration to address the issue of rising generic medication costs, e.g. bulk compounding in accordance with the 2013 Compounding Quality Act, temporary importation of foreign approved drugs, expedited Abbreviated New Drug Application (ANDA) review for off-patent drugs not subject to competition, and changes to Hatch-Waxman exclusivity provisions.


As the gatekeepers of pharmaceuticals, the Food and Drug Administration (FDA) has been urged to become more involved in the accessibility and affordability of essential drugs entering the market, even after their patents have expired. In a free market, prices of pharmaceuticals are not regulated by law or the FDA. Off- patent drugs have lost their legal monopoly, yet their prices have increased over the last three years. One reason for price drug increase is the lack of competition. Our analysis revealed that many common medications widely used in practice today have increased in price over the last 3 years. FDA and other policy makers have an essential role in pursuing policies and strategies to ensure patient access and affordability to off-patent pharmaceuticals to reduce both morbidity and mortality.

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