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Andrx's New-Style Generics

Executive Summary

Andrx is at the forefront of a new breed of generics companies: diversified, entrepreneurial, litigious, and competent at handling complex science. In the mid-1990s, when the last big wave of patent expirations created huge opportunities for generics, the industry responded with debilitating price wars, conniving tactics to tie up raw material supplies, and too many me-too drugs. These days are gone. Industry consolidation has weeded out weaker players, helping to stabilize pricing and increase resources, and generics companies are far more sophisticated and diversified than in the past. Andrx picked up early on trends in the industry--its founders saw a gap in generic distribution that others didn't see, and set up a generic drug distribution business to service independent pharmacies. It was among the first to realize that one way to avoid price wars would be to focus on hard-to-manufacture products using innovative technologies to avoid infringing patents. It has from its inception emphasized diversification, positioning itself as a drug delivery company that can apply its proprietary technologies to both generics and branded products. It is evolving into branded products, first by in-licensing niche, undermarketed drugs from big pharma companies, and then by developing improved versions of branded drugs that are about to go off patent. But being a drug delivery company is tough, and Andrx has yet to prove that it has both a creative enough drug delivery technology and the marketing savvy to be a success at it.

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Efforts to fix perceived imbalances in the Hatch-Waxman Act once again are underway in Washington and, for the first time, some of them are likely to have an impact on both the brand-name and generic drug industries. An FDA rule announced in June and implemented in August aims to clear up some of the legal ambiguities that have played a critical role in shaping corporate strategies. A bill pending in Congress would further modify the act, if it passes.

A Precarious Union: Combining Proprietary and Generic Businesses

The major generics companies, flush with cash from the recent plethora of patent expirations, are all forging ahead in the proprietary business in order to boost margins and even out the volatile revenues and earnings inherent in their core business. They're pursuing, by and large, strategies that don't take them far from their core expertise and involve reformulating known compounds. Some companies have had moderate success, but weaving together two such disparate businesses is a challenge.

A Precarious Union: Combining Proprietary and Generic Businesses

The major generics companies, flush with cash from the recent plethora of patent expirations, are all forging ahead in the proprietary business in order to boost margins and even out the volatile revenues and earnings inherent in their core business. They're pursuing, by and large, strategies that don't take them far from their core expertise and involve reformulating known compounds. Some companies have had moderate success, but weaving together two such disparate businesses is a challenge.

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