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An US Federal Appeals Court ruling, which invalidates King Pharmaceuticals Inc’s patent for blood-pressure drug Altace, spells a breakthrough for Indian generic drug maker Lupin. However, the launch of the generic version is still dependent on USFDA approval for Ramipril — the active ingredient for this drug.

Aventis owns the patent in question while the drug is marketed by King Pharmaceuticals.

The drug Altace generates annual revenues of over $900 million in the US. A launch of the generic version of this drug by Lupin before the end of this year, could allow it to draw maximum mileage from this opportunity.

King Pharmaceuticals has been planning to launch a new formulation of this drug by 2008, with the aim of switching Altace consumers to the new drug, before the older drug faces an onslaught from generic manufacturers. While it is true that a branded product can suffer significant price erosion (sometimes as much as 80-90 per cent) once cheaper generic versions appear on the market, this development still opens up a new market for Lupin.

However, the company is currently in the process of determining the timing of the launch as it awaits the regulatory nod. Any exclusivity period, which is as yet unannounced, would make its case even stronger.

The US Court has reversed a lower Court’s ruling that Lupin had infringed the patent by seeking regulatory approval to make a generic version. The drug’s patent is due to expire in October 2008. King Pharmaceuticals, on its part, would like to seek a re-hearing with the court. — BL Research Bureau

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