Generic Levothyroxine: Approved Low-Cost Versions

Approved Low-Cost Versions of Synthroid and Levoxyl

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On June 23, 2004, 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 argued 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 three 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 at the time, Abbott and King, scrambled to defend their products Synthroid and Levoxyl against this new onslaught of lower-priced competition.



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

What Was the Impact on Thyroid Patients?

First, the Abbott army of PR and drug reps was 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 was no research to establish this, and the FDA had declared these bioequivalent drugs, there was a strong sales pitch to press, docs and pharmacies to tout Synthroid and disparage the generics. This message in turn was also voiced by doctors, who told patients that "the new generics aren't as good as Synthroid."

Second -- drug companies stopped claims that one brand was better than another, or that brands are better than generics. To date, peer-reviewed, double-blind research still has not been published that compares the effectiveness and/or superiority of particular brands vs. the generics, and there is no evidence that one brand of levothyroxine is better than another, or that the generics don't perform equally as well as the brand name levothyroxine drugs.

Third, insurance companies and HMO's shifted many patients over to lower-cost generic levothyroxine. There are so many people on these drugs that even a few dollars a month savings, when multiplied by many thousands of patients, resulted in significant cost savings that these groups will wanted to enjoy.

 

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