PRNewswire (Mar 31, 07:11 AM) DURHAM, N.C., March 31 /PRNewswire/ -- IMPAX Laboratories announced that the U.S. Food and Drug Administration (FDA) has granted final approval to begin producing a generic version of Wellbutrin SR 150 mg tablets developed by GlaxoSmithKline for the treatment of depression. According to NDCHealth, U.S. sales of Wellbutrin SR 150 mg were approximately $1.3 billion in 2003. Generic drugs are becoming a decisive issue for pharmaceuticals, and addressing the inevitability of the intense competition they present to branded drugs is a complex process, according to a new report, "Combating Generics: Pharmaceutical Brand Defense" ( http://www.pharmagenerics.com/ ), from pharmaceutical business research firm Cutting Edge Information.
Generic companies recently received a boost in the United States when increasing pressure from consumers, generic industry lobbyists, insurance organizations, and other constituencies drove legislative reform resulting in amendments to the Hatch-Waxman Act. As patent expirations roll around, generics are more consistently attempting to enter the market earlier, and are doing so with more success. In fact, generic companies win more than 70% of patent challenge lawsuits settled in court.
"Choosing from a menu of strategies such as patent litigation, defensive pricing, franchise line extensions, and Rx-to-OTC switching, many companies find that transitioning patents to line or franchise extensions is an effective means of retaining market share," says Jon Hess, senior analyst at Cutting Edge Information. "Drug companies must prepare a multi-strategy plan for retaining market share well in advance of patent expiration."
The growth of the generics industry - and the corresponding increase in the number of blockbuster patent expirations - has substantial implications for the future success of the branded prescription drug industry. Generic sales are expected to top $80 billion by 2008.
In the report, "Combating Generics: Pharmaceutical Brand Defense," ( http://www.pharmagenerics.com/ ), Cutting Edge Information showcases competitive strategies from both branded and generic drug-makers. The report contains strategies from Sandoz, AstraZeneca, Genentech, Eli Lilly, Mylan Laboratories, and Teva Pharmaceuticals, among others.
To download a summary of this 190-page report, visit http://www.pharmagenerics.com/ . For more information or to learn about other Cutting Edge Information research, contact Diana Borja at diana_borja@cuttingedgeinfo.com or 919-433-0219. For media inquiries call Tricia McGovern at 919-433-0217 or tricia_mcgovern@cuttingedgeinfo.com .
Cutting Edge Information
CONTACT: Diana Borja, +1-919-433-0219, ordiana_borja@cuttingedgeinfo.com; or media, Tricia McGovern, +1-919-433-0217,or tricia_mcgovern@cuttingedgeinfo.com, both of Cutting Edge Information
Web site: http://www.cuttingedgeinfo.com/http://www.pharmagenerics.com/
