Generics
Mylan’s attempt to stop Ranbaxy’s Lipitor exclusivity fails
On 2 May 2011 a federal judge dismissed Mylan’s attempt to block rival generic company Ranbaxy Laboratories from launching a generic version of Pfizer’s blockbuster cholesterol-lowering drug Lipitor (atorvastatin) and trying to terminate Ranbaxy’s rights to sell generic atorvastatin in the US on an exclusive basis for six months.
Concerns over international reference pricing in the EU
An independent report commissioned by the European Parliament’s committee for Environment, Public Health and Food Safety (ENVI) has highlighted some problems with access to medicines due to the widely used practice of international reference pricing within the EU [1].
Generic substitution rates in South Africa
Research carried out by the School of Pharmacy at the North-West University, South Africa, has shown that generic substitution rates for antidepressants increased between 2004 and 2006. Meanwhile antidepressant use decreased over the same period while the average cost decreased in 2005, but increased again in 2006.
Ranbaxy launches generic olanzapine in Spain
Eli Lilly may be facing pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 25 April 2011,the first day after Eli Lilly’s patent exclusivity expired in Spain, Ranbaxy Laboratories announced that it had launched its generic version of the treatment.
Savings due to generic substitution in South Africa
A retrospective analysis of medical claims for antidepressants during 2004–2006 in South Africa calculated potential savings of 9.3% of the actual antidepressant cost over the study period.
Generic prices in Australia slashed
In response to an article by Professor Philip Clarke in the Australian Financial Review titled Time to slash cost of generics, Medicines Australia Chief Executive Dr Brendan Shaw hit back saying that ‘the price of generic medicines on the Pharmaceutical Benefits Scheme (PBS) is already being reduced by as much as 70%.’
Branded generics and generics branding for Merck and sanofi-aventis
While Merck is getting a firm foothold in emerging markets with a branded generics deal with India-based Sun Pharma, sanofi-aventis has decided to unify its generics business under the brand name Zentiva.
The status of generic substitution in South Africa
In South Africa only around 13% of the population live in what we would call ‘first world’ conditions. More than half the population (around 48 million people) live in developing world conditions according to researchers from the School of Pharmacy at the North-West University, South Africa.
Bioequivalence of generic cyclosporine
A clinical trial in allogeneic stem cell transplant (ASCT) recipients found that generic and branded cyclosporine could be considered interchangeable.
FDA rejects pseudoephedrine application due to deficiencies
On 11 March 2011 SCOLR Pharmaceuticals announced it had received a letter from the FDA identifying deficiencies regarding its Abbreviated New Drug Application (ANDA) for its generic extended-release pseudoephedrine.
