Israel’s Teva Pharmaceutical Industries is suing the US Food and Drug Administration over its bid to get six-months’ marketing exclusivity to sell its generic version of Johnson & Johnson’s schizophrenia blockbuster Risperdal.

With the lawsuit, Teva is seeking an order requiring the FDA to relist the main patent on Risperdal (risperidone) which the agency withdrew from its Orange Book of registered patents in 2001. However, Teva is arguing that the FDA failed to provide legal notice that the patent had been delisted prior to the firm’s submission in the same year of a Paragraph IV certification to the risperidone patent.

With the latter, the Israeli firm was looking to get 180-day exclusivity for its copycat version of Risperdal which brought in $2.2 billion in US sales last year for J&J. However, it will go off-patent there at the end of June but given that it has been de-registered, this could mean that any number of drugmakers, not just Teva, will try and get their generics approved and straight onto the market.

Teva has tried, through a Citizen’s Petition, to get the FDA to relist the risperidone patent and grant it exclusivity, a bid that has failed, hence the lawsuit. Furthermore, and rather embarrassingly for the agency, a notice mistakenly went up earlier this week on the FDA website saying that Ranbaxy Laboratories has been granted approval to sell a generic version of Risperdal, which was news to the Indian drugmaker. The error has now been rectified.

Teva expanding in Ireland
Meantime, Teva’s IVAX subsidiary has announced that it has begun an investment programme totalling 65 million euros at its facility in Waterford, Ireland, which will create an extra 165 jobs over five years. The company currently employs 650 staff there.

Tom McCabe, general manager of the Waterford facility, said the investment is necessary to meet increasing demand for both solid dosage forms and respiratory products such as Teva’s branded asthma inhaler ProAir (albuterol), particularly in the USA.