Hours after Johnson & Johnson’s US patent on Risperdal expired, Teva Pharmaceutical Industries announced that it has already started shipping its generic version of the blockbuster antipsychotic.

The Israel-based firm said that the US Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for a copycat version of Risperdal (risperidone) and being the ‘first-to-file’, Teva has been awarded a 180-day period of marketing exclusivity.

The approval, and that all-important six months’ exclusivity, follows a court order issued in April that backed Teva’s bid to get the FDA to relist the main patent on Risperdal which the agency withdrew from its Orange Book of registered patents in 2001. The FDA has appealed that decision and a hearing has been scheduled for September 12.

However J&J has also moved swiftly and has launched an authorised generic version of Risperdal through its Patriot Pharmaceuticals subsidiary. The company’s branded drug will still be available for the treatment of schizophrenia in adults and adolescents aged 13 to 17 and irritability associated with autistic disorder in children aged 5-16.

Despite this move, J&J’s US sales of risperidone, which reached approximately $2.6 billion in the twelve months ended March 31, will be hit hard. Analysts have also been disappointed by the sales performance thus far of the company’s Risperdal follow-up Invega (paliperidone) which is struggling to shake off its ‘me-too’ tag.

Teva MS antisense drug impresses in study
Back to Teva and the firm has said that a Phase IIa study of its investigational multiple sclerosis drug ATL/TV1102, partnered with Australia's Antisense Therapeutics, has produced encouraging results.

In a study of 77 relapsing-remitting MS patients, the drug was shown to reduce the number of new brain lesions by 54.4% after eight weeks, compared with placebo. Teva added that based on the data, it intends to conduct additional pre-clinical and clinical research before continuing to a Phase III study “with this unique and promising molecule”.

As a result of continuing ATL/TV1102's development, which was discovered by the USA’s Isis Pharmaceuticals, Antisense will receive a $4 million payment.