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Some of the most prescribed blockbuster medications will lose market exclusivity in the next couple of years, according to a recent presentation.
Some of the most prescribed blockbuster medications, including atorvastatin, clopidogrel, montelukast, and pioglitazone, will lose market exclusivity in the next couple of years, according to information presented at the Academy of Managed Care Pharmacy's 23rd Annual Meeting and Showcase, Minneapolis.
"Accurate projection of availability of first-time generics are of utmost importance to managed care organizations [MCOs]," according to Diana Papshev, PharmD, partner, InformaCeutica (http://DrugManagementForum.com/). "To be able to effectively track generic market developments, managed care professionals need to monitor a number of potential developments and nuances. In addition to patent expiration dates, key aspects of generic forecasting include patent challenges through abbreviated new drug applications [ANDAs] with paragraph IV certifications, patent litigation, market exclusivities, at-risk launches, and authorized generics."
Forecasting aids MCOs in cost-saving plans, according to Dawn Erdman, RPh, pharmacy clinical program manager director-coverage management, Aetna Pharmacy Management. "As a health plan, our desire is to have generic drugs come to market sooner than anticipated," Erdman said. "While there can be unpredictability in forecasting generic launches using the Hatch-Waxman Act, we have experienced its beneficial effects as it has lowered healthcare costs and improved access to certain drugs for our members."
If a patent challenge resulted in litigation, follow brand manufacturer information on blogs, corporate websites, and FDA's website to determine which patents were at issue and the outcomes. When FDA approval is granted in the midst of ongoing litigation, a generic product may not become available until lawsuits are resolved or the product may launch at-risk. First generics may get 180-day exclusivity; afterward generic prices become more competitive (lower).
The first biosimilar products to enter the market through the abbreviated biologic license application pathway are not expected for another 4 to 10 years. The Biologics Price Competition and Innovation Act created a conduit for biosimilar entry into the marketplace, yet the regulatory process for approval of these agents has not yet been defined by FDA.
The law states that reference biologic exclusivity will be for up to 12 years, but it is expected that patent disputes will be more complex and protracted than with generics. Also, European experience indicates that biosimilars are likely to have a moderate price discount and limited market penetration. The European market has approved a few biosimilar products, and the United States lags behind with details to be worked out.