Generics

Efficacy and tolerability of generic and branded atorvastatin

In a study carried out in Korean patients the efficacy and tolerability of generic and branded atorvastatin was evaluated and found to be similar in Korean patients at high risk for cardiovascular events.

Generic substitution in Norway

Using a dataset extracted from the Norwegian prescription database containing all prescriptions written in the period January 2004 to June 2007, an analysis was carried out on two brand-name and two generic statin drugs used to treat high cholesterol and showed that prices have a clear impact on generic substitution [1].

Teva again files citizen petition against generic Copaxone

Teva Pharmaceutical Industries announced on 12 December 2010 that the company had filed another Citizen’s Petition (CP) with the FDA requesting that the agency refuse to approve any abbreviated new drug application (ANDA) for generic versions of Copaxone (glatiramer acetate injection).

Teva setbacks

Teva axes 200 jobs as facility remains closed

After stopping all production at its plant in Irvine, California, USA; in April 2010, Teva announced on 20 January 2011 that all 200 jobs will go.

Race you for US$1.8 billion

The market for proton pump inhibitor pantoprazole in the US is estimated to be worth Euros 1.3 billion a year, and drug companies are scrambling to sell generic versions now that Pfizer’s patent has expired.

Generics to cash in on swine flu epidemic

Indian drug manufacturer Natco Pharma has filed an abbreviated new drug application (ANDA) with the FDA for a generic version of Tamiflu (oseltamivir), challenging Gilead Science’s patent protection on the drug.

Impact of generic substitution in Finland

Mandatory generic substitution was introduced in Finland on 1 April 2003. A recent study compared the impact of generic substitution on both originator and generic pharmaceutical companies in Finland.

The biggest US patent expiries of 2010

While the much talked-about patent cliff will not hit until 2011, 2010 has been witness to patent expirations of some of the industry’s blockbuster drugs.

European Commission to investigate patent settlements again

The European Commission (EC) has once again requested information from pharmaceutical companies regarding patent settlement agreements concluded in the European Economic Area (EEA) in 2010 between originator and generic companies.

New ANDAs and patent challenges for Impax Laboratories

Impax Laboratories is facing a whole barrage of patent litigation following its latest Abbreviated New Drug Application (ANDA) filings and approvals with the FDA.