Generics

Generic substitution in Norway

Generics/Research | Posted 18/03/2011

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

Generics/News | Posted 18/03/2011

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

Generics/News | Posted 11/03/2011

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

Generics/News | Posted 11/03/2011

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

Generics/News | Posted 11/03/2011

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

Generics/Research | Posted 04/03/2011

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

Generics/General | Posted 04/03/2011

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

Generics/General | Posted 04/03/2011

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

Generics/News | Posted 04/03/2011

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

Birth pangs of the Medicines Patent Pool

Generics/General | Posted 25/02/2011

The Medicines Patent Pool (MPP) is an initiative designed to streamline patent licensing for generic versions of patented HIV treatments, in order to obtain lower prices for medicines in countries where people are unable to afford the drugs.

Generic substitution causing confusion

Generics/Research | Posted 25/02/2011

How do customers and pharmacists really experience generic substitution? This is the question asked in a recent research article [1].

Generic and branded acetylcysteine bioequivalent

Generics/Research | Posted 25/02/2011

A single-dose study of acetylcysteine 600 mg found that three tablets of 200 mg of the generic formulation given orally were bioequivalent to a single 600 mg tablet of the branded drug.

Impax challenges Simcor patent

Generics/News | Posted 25/02/2011

On 26 November 2010, generic drug maker Impax Laboratories announced that it is challenging the patent covering Abbott Laboratories’ cholesterol-treatment drug, Simcor (niacin/simvastatin).

The therapeutic equivalence of brand-name and generic narrow therapeutic index (NTI) cardiovascular drugs

Generics/Research | Posted 11/02/2011

There are many physicians and patients who have concerns that the bioequivalent generics may not have an equivalent nature in terms of their clinical effect and benefit. In the realm of cardiovascular disease, this can include such parameters as heart rate, blood pressure and laboratory measurements.

The therapeutic equivalence of antiplatelet agents, ACE-inhibitors, statins and alpha-blockers

Generics/Research | Posted 04/02/2011

The potential changes in pharmacy formulary policy, due to the availability of generic versions of cardiovascular drugs, should be based on as much evidence as possible.

Pharmacy chains in Norway do not stock generics

Generics/News | Posted 04/02/2011

It turns out that pharmacy chains in Norway do not stock the cheapest generic products. This finding came after the Norwegian Medicines Agency (NoMA) investigated after receiving a complaint from the British generics manufacturer Arrow that its products were not sold in branches of the three largest pharmacy chains in Norway: Apotek1 (Phoenix), Vitusapotek (Celesio) and Alliance/Boots Apotek (Alliance Boots).

The clinical equivalence of generic and brand-name calcium channel blockers

Generics/Research | Posted 31/01/2011

Companies seeking to launch a generic drug are required to submit a dossier to authorities, which does not contain the results of extensive preclinical and clinical testing demonstrating safety and efficacy in the target population, as is the case with novel drugs, but only limited data and evidence demonstrating the fundamental premise that the generic is bioequivalent to its brand-name counterpart.

Medicines pricing policies in Europe: a review

Generics/Research | Posted 31/01/2011

The OECD countries spent 4.6% more per capita per year on pharmaceuticals from 1995 to 2005 although the annual average economic growth was only 2.2% during the same period [1].