Generic Prozac Poised to Hit Shelves

W A S H I N G T O N, Aug.1 -- The 2 million Americans who take the antidepressant drug Prozac should have an alternative as early as Friday.

Brand-name drug-maker Eli Lilly's patent on the drug expires at midnight Thursday, and competitor Barr Laboratories hopes to step in immediately with a generic version. Barr has tens of millions of capsules of generic Prozac ready for shipping.

The Food and Drug Administration has given tentative approval for Barr to sell its version, and is expected to give final approval Thursday.

Brand-name Prozac costs more than $2.50 a day. Barr's generic version — known by its chemical name, fluoxetine — is expected to be about 25 percent cheaper. The price could drop even further early next year, when more generic brands of Prozac will be able to enter the market.

A Long Battle

Prozac, which had domestic sales of $2.2 billion last year, has been lucrative for Lilly. With its original patent expiring, the company had secured another patent through 2003.

Barr devoted five years and $10 million in legal fees to fighting the new patent. The federal courts agreed, ruling that the 2003 patent was invalid.

"On a lot of different fronts, we were fighting a brand industry that's always about one thing," says Bruce Downey, Barr's CEO. "We want to get into the market and they want to keep us out."

Other Popular Drugs Coming Off Patent

Patents are set to expire on several blockbuster drugs in the next few years, including allergy drug Claritin and antidepressant Zoloft. The brand-name companies stand to lose billions when they enter a competitive marketplace.

"We've been preparing ourselves for this day, and we are prepared to face generic competition and actually emerge out of this as the growth company in our industry," said Sydney Taurel, chairman and CEO of Eli Lilly.

Prozac Redux

Lilly has brand new drugs in the pipeline, but is also marketing Prozac in other forms — each of which can be patented.

"They've created what I would call several Prozac knockoffs, which they've given different names," said Ira Loss, a health-care analyst at Washington Analysis.

Among the new versions are Prozac Weekly, which patients take once a week, and Serafem — Prozac by a different name — which is prescribed for premenstrual symptoms.

Lilly plans to appeal its loss to Barr, to the U.S. Supreme Court. But when and if the court rules, generic forms of daily Prozac will already have flooded the market.