Generic Prozac Equivalent to Reach Drugstores Today

Barr Laboratories Inc. began shipping its version of Prozac, the hugely successful drug that revolutionized the treatment of depression, in the biggest generic drug launch ever. The drug was expected to be available at pharmacies beginning today.

Barr’s version of the anti-depressant is the first of a flood of cheaper, generic forms of Prozac that will be rolling toward U.S. drugstores, following approval by U.S. regulators on Thursday of numerous copycat versions of Eli Lilly & Co’s blockbuster.

Eli Lilly’s patent for Prozac expired Thursday, paving the way for Food and Drug Administration approval of Barr’s product, which is called fluoxetine and is available only with a prescription.

Barr will have 180 days as the only generic seller of that form, which accounts for about $2.2 billion of Lilly’s $2.6 billion in annual sales of Prozac.

A handful of other generic firms also got in on the act, winning FDA approvals Thursday for a variety of less popular dosages and formulations of fluoxetine.

Barr’s stock fell $4.31 to close at $80.73 on the New York Stock Exchange.

A 30-day supply of 20 mg. Prozac capsules now costs about $80 to $95 in the United States, depending on location, but Barr’s version is expected to be priced about 30% lower. The cost probably will come down further in about six months, when more knockoffs of the main dosage form are permitted to be sold.

Prozac, launched in 1988, became a blockbuster because it lacks the harsh side effects of earlier anti-depression medicines, an advance that spurred more doctors to prescribe the medicine and helped end some of the stigma surrounding mental illness.

The generics will spell good news for health insurers, many of whom will no doubt try to steer patients to the cheaper copycats.

A six-year battle over rights to Prozac ended last week when a federal judge in Indianapolis issued an order invalidating a patent that would have protected Lilly’s monopoly until December 2003. Lilly still plans to appeal but conceded it is unlikely the case will be heard.

Barr’s facility in Forest, Va., has been working 10 hours a day, six days a week, since February to manufacture the 150 million capsules for the launch of fluoxetine. It typically takes Barr three weeks to fully launch a drug.

The Federal Trade Commission is studying whether drug companies are trying to block the launch of generic drugs but is also exploring if the generic firms are colluding with the big players to benefit.