Teva Pharmaceutical Industries has won a major victory in its bid to get six months’ marketing exclusivity in the USA for its generic version of Johnson & Johnson's antipsychotic blockbuster Risperdal.

The Israeli firm expects to get approval from the US Food and Drug Administration and that all-important 180-day period of exclusivity to sell its brand of Risperdal (risperidone) by the end of June after Judge Royce Lambeth in the District of Columbia backed the company in a lawsuit it brought against the agency. The case saw Teva seek an order requiring the FDA to relist the main patent on Risperdal which the agency withdrew from its Orange Book of registered patents in 2001.

Teva argued 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. Risperdal goes off-patent on June 29 and the Petah Tikva-headquartered firm feared that as it has been de-registered, this could have meant that any drugmaker, not just Teva, would try and get their generics approved and straight onto the market.

The decision by Judge Lambeth can (and probably will) be appealed, but if Teva wins again, this will be a blow to fellow generics giant Mylan, which had sided with the FDA on the view that there should be no exclusivity granted to any firm in the Risperdal case. The drug is J&J's best-seller, and brought in $2.5 billion in the USA last year.

Copaxone reduces MS relapse rates – study
Staying with Teva, the firm has also benefited from data from a three-year study published in the European Journal of Neurology, which demonstrates that its multiple sclerosis drug Copaxone (glatiramer acetate) slowed disease progression and led to fewer relapses in patients who did not respond to other treatments.

The 114-patient study showed that patients who switched to Teva's Copaxone after failing treatment with a standard interferon drug experienced 77% fewer relapses of their disease. Patients switched among different interferon treatments also had fewer relapses, but those who started taking Copaxone also demonstrated slowed disability progression.