The Generics are Coming, The Generics are Coming!!!

June 24, 2004 -- On June 23, the U.S. Food and Drug Administration (FDA) denied a Citizen Petition that Abbott -- maker of Synthroid -- had filed in August 2003 regarding bioequivalence of levothyroxine sodium products. The company was arguing that the methods for designating bioequivalence were subject to error, and could potentially mean that products of varying potencies would be deemed bioequivalent. The FDA, however, turned down this request, which has opened the door for generic levothyroxine products.

Many manufacturers were waiting in the wings, as 3 separate companies announced on June 24, 2004 that they had received FDA approval for their generic levothyroxine products, including:

Mylan Laboratories -- which received approval for levothyroxine sodium tablets in a variety of popular strengths, generic versions of Synthroid.

Sandoz Inc. -- AB-rated (bioequivalent) levothyroxine to both Synthroid and Levoxyl.

Lannett Company -- approval of the levothyroxine made by Jerome Stevens Pharmaceutical, Inc. (JSP), Lannett's exclusive supplier, bioequivalent to Levoxyl. Note: The product made by Jerome Stevens and distributed by Lannett, which is also sold under the brand name "Unithroid," was the first levothyroxine approved by the FDA.

As can be expected, the two top brand name levothyroxine manufacturers, Abbott and King, are scrambling to defend their products Synthroid and Levoxyl against this new onslaught of lower-priced competition.

With all three companies starting to ship their generic levothyroxine drugs immediately, both Abbott and King saw drops in stock prices on anticipation of lost market share.

What Can You Expect?

First, the Abbott army of PR and drug reps is already out in force, inundating journalists with press materials, and contacting pharmacies and doctors to continue attempting to position Synthroid, the second-most-prescribed drug in the United States, and the source of $818 million in sales in 2003, as the "better" levothyroxine. Even though there is no research to establish this, and the FDA has declared these bioequivalent drugs, expect the sales pitch to press, docs and pharmacies to tout Synthroid and disaparage the generics. This message will in turn will be voiced by your own doctor, who is likely to tell you that "the new generics aren't as good as Synthroid."

Second -- question any claims that one brand is better than another, or that brands are better than generics. Until peer-reviewed, double-blind research is published that compares the effectiveness and/or superiority of particular brands vs. the generics, there is no evidence that one brand of levothyroxine is better than another, or that the new generics won't perform equally as well as the brand name levothyroxine drugs.

Third, expect your insurance companies and HMO's to attempt to shift you over to a lower-cost generic levothyroxine. There are so many people on these drugs that even a few dollars a month savings, when multipled by many thousands of patients, would be a significant cost savings that these groups will likely attempt to recoup.

What Does It Mean for You?

The question is whether or not this is good or bad news for consumers who take levothyroxine drugs. Only you and your doctor can know for sure, but here are some considerations.