Ranbaxy's plan for Lipitor fuels speculation

With hardly four weeks for patent expiry of the world’s largest revenue earning drug, Lipitor, in the US, speculation is rife as to how Ranbaxy will exploit this.

The generic products company had challenged the patent and secured a six-month exclusive right to sell a low-cost version of the $10.7 billion medicine in the US market after the expiry. It remains to be seen how it would monetise the opportunity.

The uncertainty over Ranbaxy’s ability to launch a generic version of Lipitor is caused by the absence of necessary production and marketing approvals from the American drug regulator, the Food and Drugs Administration (FDA), until now. The FDA had put two of Ranbaxy’s Indian manufacturing facilities under a regulatory scanner by stopping all product approvals from those facilities after it found some discrepancies a few years before. The company, which had applied for marketing approval for the Lipitor generic, known by the chemical name of Atorvastatin, from one of these plants, is yet to solve this problem.

While Ranbaxy and its majority stakeholder, Japanese drug major Daiichi Sankyo, had repeatedly expressed confidence over their ability for a timely launch, reports from across the world give indications of alternate plans. The latest in the speculation, posted on an Israel-based news website, ynetnews.com, is about a marketing deal Ranbaxy has allegedly signed with Teva, the world’s largest generic drug maker, to sell the Lipitor generic on its behalf during the exclusivity period if it failed to get product approval on its own.

Industry experts have not given much credence to the report, as they feel ‘trading of exclusive rights’ may not be so easy under US laws. Daiichi Sankyo had, in a recent communication, stated that Ranbaxy would start selling the Lipitor generic in the US from November 30. The company had also ruled out the possibility of giving away the exclusive rights to a third party.

Earlier reports had hinted that the company planned to manufacture the drug at its site in New Brunswick, US, and was in the process of getting necessary regulatory approvals.

Ranbaxy, which is to announce its third quarterly results on the coming Wednesday, declined to comment on its Lipitor generic plans.

Meanwhile, Pfizer, the world’s largest drug maker, which owns Lipitor, is busy preparing to minimise the damage from the loss of patent-protected market exclusivity. It has already halved the price and has announced patient-friendly schemes to make them stick to its version of the drug even after introduction of a low-cost variant.

The company has also authorised US-based generic drug maker Watson Pharmaceuticals to sell the “authorised generic” of Lipitor after the patent expiry. US laws permit the patent holder to allow one such “authorised generic”, to be marketed during the six-month exclusivity period.