Generics
AstraZeneca settles patent dispute over Seroquel XR
In an out-of-court deal, AstraZeneca has agreed with Accord Healthcare, Handa Pharmaceuticals and Intas Pharmaceuticals that the latter can sell generic forms of the antipsychotic blockbuster Seroquel XR (quetiapine fumarate) from 1 November 2016.
Translational research to uncover new uses for generics
On the surface, generic compounds and translational medicines could not appear more different. However, in April 2011, the US National Institutes of Health (NIH) met with academic, governmental, and industry R & D experts to discuss whether translational methods could help to rescue and re-position certain generics [1].
Generic olanzapine now approved in US
Eli Lilly has no safe haven left as the FDA announced on 24 October 2011 that it had approved the first generic olanzapine (for treating schizophrenia and bipolar disorder) drugs, one day after the company lost its patent protection on Zyprexa (olanzapine) in the US on 23 October 2011 [1].
South Africa-India alliances for generics and drug delivery systems
South Africa-based Litha Healthcare Group signed an exclusive agreement with Indian generic drugmaker Natco Pharma (Natco) on 19 September 2011. Under the group’s newly formed generics business unit, the agreement will include a range of generic pharmaceutical products developed and manufactured by Natco.
Row continues over drug shortages
Unhappiness about persistent drug shortages is becoming more acute, both in Europe and the US. Hospitals in The Netherlands are routinely short of around 40 products, whereas in the US 180 medications have now made it onto FDA’s list of scarce products. Hospital pharmacists spend an increasingly large amount of time trying to source scarce items and, despite their best efforts, doctors and patients are increasingly noticing the scarcities.
Access to generic medicines undermined in free trade agreement
On 19 October 2011, several leading Congressional Democrats wrote a letter to the US Trade Representative urging him to ensure that access to generic medicines in the developing world is not undermined during negotiations for the Trans-Pacific Partnership (TPP), currently being carried out in Peru between the US and the Asia-Pacific region.
European Commission investigates Johnson & Johnson and Novartis over delaying generics
As part of its ongoing antitrust investigations, the European Commission (EC) announced on 21 October 2011 that it is looking into agreements between Johnson & Johnson (J&J) and Novartis to determine whether they delayed the entry of a generic version of the fentanyl painkiller in The Netherlands. If the drugmakers had ‘contractual arrangements’ that hindered a generic drug, this would ‘potentially’ breach EU antitrust rules.
Injectable generics at Strides Arcolab
India-based drug firm Strides Arcolab announced on 3 October 2011 that it had received FDA approval to market injectable clindamycin, used in the treatment of bacterial infections, in the American market.
Another olanzapine generic hits the market
The competition is hotting up for Eli Lilly as yet another generics maker joins the list of those already producing copies of its blockbuster antipsychotic drug Zyprexa (olanzapine).
Representatives object to 7-year biologicals exclusivity
In the ongoing debate about the exclusivity period for biologicals in the US, the latest group to voice their opinions are members of the US House of Representatives. In a letter to President Barack Obama, dated 14 October 2011, the 51 Representatives outlined their objections to the President’s continued efforts to reduce the exclusivity period for originator biologicals.
