Generics

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).

Industry adjustments as patents expire

Generics/General | Posted 14/10/2011

Analysts are making some positive predictions as they consider the implications of the continued patent expiry of many blockbuster originator drugs.

Generics saved US$931 billion over last 10 years

Generics/Research | Posted 07/10/2011

On 21 September 2011, the US Generic Pharmaceutical Association (GPhA) released the results of an independent analysis showing that the use of generic drugs in the US has saved patients and the healthcare system US$931 billion between 2001 and 2010.

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].

Generic atorvastatin may be better than Crestor

Generics/Research | Posted 30/09/2011

AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin) failed to show a statistically significant benefit over Pfizer’s Lipitor (atorvastatin), according to results of a phase IIIb trial. The results could prove to be good news for generics manufacturers, boosting sales of generic atorvastatin, soon to compete with Crestor.

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.

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.

Generics production pulled in different directions

Generics/News | Posted 23/09/2011

A few months ago it was predicted that generics manufacturers were moving ahead with the development and commercialisation of better manufacturing technologies. The largest firms had now developed to the point at which they can start to develop new manufacturing technologies and thus lower their costs. This was going to lead, on the one hand, to lower prices for products and at the same time, higher profits for those firms able to develop in this way, who were then going to further consolidate their market position.

Tendering for medicines in ambulatory care

Generics/Research | Posted 16/09/2011

Tendering is a mechanism whereby a purchaser buys medicines from the pharmaceutical manufacturer that offers the best bid [1]. Whereas tendering is widely used in the hospital sector, it is only recently being rolled out in ambulatory care in an increasing number of countries with a view to constraining pharmaceutical expenditure. Denmark, Germany and The Netherlands are the countries that have taken up the idea most readily. However, the success of this strategy is not yet clear compared to other European generic medicines pricing policies.

Ranbaxy to launch generic atorvastatin on time

Generics/News | Posted 16/09/2011

Ranbaxy Laboratories will release a generic version of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) in the US at the end of November 2011 as planned, according to a report in the Japanese newspaper Nikkei.

US drug shortages prompt oncologists to go into drug manufacture

Generics/News | Posted 09/09/2011

Drug shortages in the US are at a record high and there appears to be no quick solution to the problem. Legislation, government stock-piling and physicians importing or even manufacturing drugs are just some of the solutions being proposed.

Sanofi France to make generic atorvastatin

Generics/News | Posted 09/09/2011

The French daily newspaper, Les Echos, reported on 1 September 2011 that sanofi France (sanofi) had reached an agreement with Pfizer to produce generic versions of the blockbuster cholesterol drug Lipitor (atorvastatin).

Ranbaxy launches generic esomeprazole in the UK

Generics/News | Posted 09/09/2011

India-based Ranbaxy Laboratories announced on 5 September 2011 that it had successfully launched esomeprazole magnesium 20 mg and 40 mg tablets in the UK.

Teva continues its fight to prevent generic glatiramer acetate

Generics/News | Posted 02/09/2011

Teva Pharmaceutical Industries (Teva) has not given up the fight to keep generics competition away from its blockbuster drug, Copaxone (glatiramer acetate). The company announced on 29 August 2011 that a US federal court had rejected interpretation claims from its challengers in patent infringement lawsuits over its proprietary multiple sclerosis treatment, setting a trial date of 7 September 2011.

New Spanish prescribing laws to promote generics

Generics/General | Posted 02/09/2011

In an attempt to reduce the healthcare bill the Spanish government has approved new rules to force Spanish doctors to prescribe and pharmacies to dispense generic drugs rather than more expensive brand-named medicines.