| OBSERVATION'S |
In the past, generic companies simply waited for agents of API manufacturers to call with product lists. Now that generic companies are focused on challenging patents, they need sophisticated API manufacturers with whom they can partner, she tells C&EN. The generic company's relationship with an API supplier is becoming more like that of an innovator's, she says. When a generic company is trying to circumvent a patent, how fast the API manufacturer can develop an alternative non-patent-infringing process is critical to the generic company's success in gaining first approval. But it's not just about technology, she adds. It's also about the API manufacturer's competitiveness, regulatory history, and manufacturing capabilities; what other products it manufactures; and whether it can provide the API in the specific way the generic company demands.
|