FDA Approves Generic Versions of Diabetes Drug

Cost Reduced by 80%

 

A variety of generic drugmakers, actually eleven of them, announced on Friday that they have received final approval from the US Food and Drug Administration (FDA) to market generic versions of Bristol-Myers Squibb Company's popular diabetes medication Glucophage (metformin).

 

The firms--Watson Pharmaceuticals, Ivax Corporation, Alpharma Inc., Teva Pharmaceutical Industries Ltd. and Mylan Laboratories Inc.--are among 11 generic-drug manufacturers that are expected to launch formulations of metformin. Barr Laboratories and Andrx Corp. have also filed applications to sell generic forms of the drug. Generic metformin is expected to sell at an 80% discount from the brand-drug price.

 

Glucophage is the world's top-selling diabetes medication. The drug reduces blood sugar levels by curbing production of glucose by the liver.

 

Bristol-Myers reported Thursday that sales of its Glucophage franchise, which includes follow-up drugs Glucovance and Glucophage XR, increased 42% in 2001 to nearly $2.7 billion. But with the approval of the generics, Bristol-Myers is expected to take a hit on its earnings this year.

The FDA approval also spells an end to the dispute over whether generic versions of the drug could be approved.

 

Bristol-Myers previously attempted to prevent the FDA from approving generic versions based upon results from recently conducted tests on children. The brand-name drugmaker argued that the FDA could not approve any generic versions because those versions would not be allowed to include labeling regarding the appropriate doses for children.

 

Ivax and Alpharma said that it would begin distributing its generic versions immediately.

Expect the generic to be about 80% less then the brand name.

So if a patient is taking Glucophage® 500mg BID their cost will go from about 45 to 55 dollars down to about 8-12 dollars. Also if your patient is on an insurance plan that only pays for generic then they can now get metformin.

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