Generics
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.
Birth pangs of the Medicines Patent Pool
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
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
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
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
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
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
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
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
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].
