Generics

Sun and Teva losing battle over generic Protonix

Generics/News | Posted 13/08/2010

On 19 July 2010, it was announced that a US court had denied a motion by India’s Sun Pharmaceutical Industries and Israel-based Teva Pharmaceutical Industries to reverse the earlier verdict of patent infringement on Pfizer/Nycomed’s gastrointestinal drug Protonix (pantoprazole).

New EGA chair to study generic medicines policies

Generics/News | Posted 13/08/2010

On 8 July 2010, Professor Steven Simoens was inaugurated as the new European Generic medicines Association (EGA) chair for ‘European policy towards generic medicines’ at the Catholic University in Leuven, Belgium. This chair is funded by the EGA in collaboration with Mylan, Ratiopharm, Sandoz International and TEVA Pharmaceuticals for a five-year period.

Court upholds decision against AstraZeneca’s omeprazole

Generics/News | Posted 10/08/2010

On 1 July 2010, the General Court of the European Union (GCEU) upheld the decision of the European Commission (EC), which found that AstraZeneca had abused its dominant position by preventing the marketing of generic versions of Losec (omeprazole).

Generics lose battle against AstraZeneca’s Crestor (rosuvastatin)

Generics/News | Posted 30/07/2010

On 30 June 2010, AstraZeneca announced that a court in the US had overruled challenges, from a number of generic producers, to the patent on its blockbuster cholesterol drug, Crestor (rosuvastatin).

Ranbaxy launches generic atorvastatin in South Africa

Generics/News | Posted 30/07/2010

Sales of Pfizer’s Lipitor (atorvastatin), the world's biggest-selling drug, are expected to take another blow as Ranbaxy South Africa (Ranbaxy SA) announced the launch of a generic version of atorvastatin onto the South African market on 8 June 2010.

Approval of ‘hybrid generic’ PecFent (fentanyl) in EU

Generics/News | Posted 09/07/2010

On 25 June 2010, Archimedes Pharma (Archimedes) announced that it had received a positive opinion from the CHMP of the EMA for its ‘hybrid generic’ PecFent (fentanyl).

Teva changes generic Yaz contraceptive label

Generics/News | Posted 09/07/2010

Israeli generic giant Teva Pharmaceuticals has agreed to change the labelling on its generic oral contraceptive, Gianvi, after Bayer Schering Pharma (Bayer) filed a lawsuit accusing the company of falsely claiming its drug was identical to Bayer’s Yaz.

Hospira’s generic antibiotic Meropenem approved in US

Generics/News | Posted 09/07/2010

On 22 June 2010, Hospira announced that it had received approval from the FDA for its generic antibiotic, Meropenem. This is the first generic launched in the antibiotic class and Hospira is the first to market.

Teva gains approval for generic breast cancer and anti-depressant drugs

Generics/News | Posted 09/07/2010

The Israeli generics’ giant Teva Pharmaceuticals is racing ahead in the generics game with the announcement of the approval by the FDA of two new drugs for treatment of breast cancer and depression.

Bioequivalence testing for generics

Generics/Research | Posted 08/07/2010

Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of most generic drug formulations. In general, bioequivalence testing provides a useful comparison for different products containing the same active ingredient. Bioequivalence studies therefore play a key role in the development of new generic products as well as in the post-marketing phase of innovator products.