Americans are used to finding low-cost generic medications about six months to a year after they’re approved by the FDA. Think Lipitor, Plavix and Lexapro, which are all priced about 80% lower as generics.
Unfortunately, patients who had been looking forward to newly-approved generic versions of Nexium, Diovan, or Valcyte will have to keep waiting as a knot of legal and regulatory guidelines delay their U.S. release. The FDA approved Indian drugmaker Ranbaxy’s generic versions of these meds but has banned the plants to be used for their production from exporting products to the U.S., due to findings of substandard manufacturing practices.
You’d think that another drug manufacturer could just make and market the drug, but the U.S. approval system doesn’t allow that. The FDA grants six months of exclusive marketing rights to the company that first gains approval for a generic drug. We wrote about this process two weeks ago in our blog post covering generic Celebrex. Even though Ranbaxy’s plants can’t export generic versions of Nexium, Diovan, and Valcyte to the U.S., it still retains marketing exclusivity in the U.S. market!
This is good news for brand name drug makers and bad news for consumers. Global sales for Nexium, Diovan, and Valcyte totaled $8 billion last year. Delays to generic Diovan have grossed Swedish drugmaker Novartis $100 million a month. Cash-paying Americans, as usual, are hurt most by these shenanigans as they continue to pay high prices for brand-name medication. Taxpayers should also be unhappy, since they are footing the bill for these brand name drugs purchased through programs like Medicare and Medicaid.
There is, however, a bit of good news on the horizon – the European Medicines Agency, an Agency under the European Union that evaluates medicinal products (like the FDA), will reinstate the good manufacturing practices certificate for Ranbaxy’s Toansa plant, which was slated to produce generic Nexium and Diovan. Hopefully, these improvements are good enough for the FDA.
In the meantime, so you’re not held hostage to drug price insanity, you can find these brand medications internationally at amazing discounts. Feel free to compare their prices:Diovan, Nexium, Ranbaxy, Valcyte