Generics/News

Injectable generics at Strides Arcolab

Generics/News | Posted 28/10/2011

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

Generics/News | Posted 28/10/2011

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

Generics/News | Posted 21/10/2011

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.

Pfizer settles with Teva but clashes with Watson over generics

Generics/News | Posted 14/10/2011

Pfizer has gained a small reprieve from generic competition against its blockbuster cholesterol-reducing drug Lipitor, at least in the UK, by making a deal with Teva UK. However, the pharma giant has sued Watson Pharmaceuticals (Watson) to try and stop it selling its generic version of Embeda (morphine and naltrexone).

Teva takes over joint venture solidifying its position in Japan

Generics/News | Posted 07/10/2011

Teva announced on 26 September 2011 that it will acquire the 50% interest formerly held by Kowa Company in Teva’s Japanese joint venture for US$150 million, giving it full control.

Actavis launches generic olanzapine in 11 European markets

Generics/News | Posted 07/10/2011

Eli Lilly is facing yet more pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 30 September 2011, Actavis announced that it had launched generic olanzapine tablets in Austria, Denmark, Finland, France, Germany, Ireland, Italy, Romania, Sweden, The Netherlands and the UK, immediately after the patents on Zyprexa expired on 26 and 27 September.

Japanese government promoting generics

Generics/News | Posted 30/09/2011

Japan is currently the world’s second largest pharmaceutical market, surpassed only by the US. The Japanese prescription drug market was valued at US$96 billion in 2010, however, only around 23% of its prescription drug sales (by volume) are generics [1].

Debate over biosimilars exclusivity period in free trade agreement

Generics/News | Posted 23/09/2011

With the eighth round of negotiations of the Trans-Pacific Partnership (TPP) agreement underway in Chicago, USA, on 12 September 2011 Democrat senators were split on the inclusion of intellectual property provisions that are consistent with US biologicals exclusivity standards, i.e. 12 years of data exclusivity.

FDA blocks Indian API supplier

Generics/News | Posted 30/09/2011

In a bid to get tough on foreign manufacturers, FDA has issued a warning letter and a US import ban to an Indian-based active pharmaceutical ingredient (API) manufacturer.