Step by step, Ranbaxy Laboratories is overcoming hurdles as it tries to regain its vaporized market share for generic Lipitor. It got past a recall, figured out how glass particles got into its API and is again manufacturing the drug for the U.S. market. Now it has also squashed an effort to force a national recall of its past production of the drug.
Ranbaxy last year recalled 41 lots of its atorvastatin and then halted production after finding minuscule glass particles in the API used to make the drug. The Indian generics maker tracked it back to a broken piece of glass lining in an API reactor at a plant in India.
Law360 reports that a federal judge in New Jersey rejected a legal maneuver that would have forced the Indian generics maker to extend the recall to the consumer level, an action that would have bolstered the cases of patients who claim they were hurt by glass in the drug. The FDA last year had Ranbaxy recall the drug from retailers but said the chance of any harm was very small. In its response to the lawsuits, Ranbaxy said the claims of one plaintiff that she had internal bleeding, holes in her stomach and colon and blood loss are just plain unbelievable.
Ranbaxy late last month got back in the generic Lipitor game, having repaired its most recent manufacturing problems, but the cost to the drugmaker was greater than many analysts expected. It reported a $91.3 million loss for its last quarter after setting aside $34.4 million to pay for the recall. Before the recall, Ranbaxy was leading the world in the production of generic Lipitor, but its share in the U.S. fell to about 3% from 43% when it held off production to investigate the glass problem.
- here's what Law360 has to say (sub. req.)