SYNAPTECH, JANSSEN FILE SUIT AGAINST BARR

Janssen Pharmaceutica and Synaptech have filed a lawsuit against Barr Laboratories alleging Barr's bid to market a generic version of dementia treatment Razadyne infringes Janssen's patent on the drug.

Janssen, a subsidiary of Johnson & Johnson, and Synaptech filed suit in the U.S. District Court of Delaware in response to Barr's abbreviated new drug application (ANDA) with a Paragraph IV certification for generic Razadyne (galantamine hydrobromide) in 4-, 8- and 12-mg dosage strengths. Barr filed the ANDA with the FDA in February.

Janssen has also received Paragraph IV certifications for Razadyne from six other generic firms, according to documents filed recently with the Securities & Exchange Commission. Janssen said it is in the process of reviewing those applications.

Razadyne currently generates annual sales of roughly $247 million, according to Janssen. Synaptech owns the patent on the drug and Janssen holds Razadyne's new drug application.