Generics

Ranbaxy may sell its generic atorvastatin exclusivity

Generics/News | Posted 02/09/2011

According to Credit Suisse analysts, Ranbaxy Laboratories (Ranbaxy) may sell its rights to make a generic version of Pfizer’s cholesterol blockbuster Lipitor (atorvastatin), should it look unlikely to gain FDA approval in time for the planned November 2011 launch.

Generics manufacturers do not have to change drug safety labels in the US

Generics/News | Posted 26/08/2011

A landmark ruling from the US Supreme Court has decided that generic drug manufacturers do not have to change their drug’s safety label, even if stronger safety warnings are found to be required [1- 2]. This is the opposite of a ruling in 2009 that decided that patients could sue the manufacturer of a brand-name drug if its safety label is found to be inadequate, e.g. when new drug-related risks are discovered after the drug has made it to market [3, 4].

Integrated prescriber dispensing can slow generic growth

Generics/Research | Posted 26/08/2011

Countries such as China, Japan and Taiwan which have public health insurance systems, and which allow physicians to both prescribe and dispense drugs themselves, are the most resistant to generics competition, according to a study by two Taiwanese health economists from the National Cheng-Kung University and Academia Sinica, Taipei, Taiwan [1].

Does switching to generic anti-epileptic drugs lead to loss of seizure control

Generics/Research | Posted 26/08/2011

Patients with epilepsy may have a higher risk of seizures if they switch from their brand-name medication to generic anti-epileptic drugs (AEDs). This is the message often heard from clinicians when expressing their concern over generic versions of narrow therapeutic index (NTI) drugs, one class of which is those used to manage the symptoms of epilepsy.

Pfizer seeks 6-month paediatric exclusivity for Lipitor

Generics/News | Posted 26/08/2011

Pfizer is poised for a Lipitor (atorvastatin) reprieve in Europe. The company has asked for six months of additional exclusivity in most EU countries under regulations designed to promote drug trials for children. The extension could be worth almost US$800 million as it staves off generic competition until May 2012.

Pilot programmes between EMA, FDA and TGA a success

Generics/General | Posted 19/08/2011

Two pilot programmes of collaboration on inspections between EMA, FDA and the Australian Therapeutic Goods Administration (TGA) have concluded successfully, according to two reports published by the EMA on 2 August 2011. The two programmes were carried out with the intention of increasing international regulatory collaboration in order to increase drug quality and safety.

Switching from a brand-name antiepileptic drug to a generic is not associated with a higher risk of seizures

Generics/Research | Posted 19/08/2011

A report in Clinical Pharmacology and Therapeutics provides further evidence that patients with epilepsy do not have a higher risk of seizures if they switch from their brand-name anti-epileptic drugs (AEDs) to the generic version [1].

How successful is the reference pricing system in Belgium

Generics/Research | Posted 19/08/2011

The main aim of a reference pricing system (RPS) is to provide generic medicines at the lowest cost to the state and individuals. This article explains how RPSs work and asks how the Belgian system might be improved to better fulfil its main objective.

GPs in the UK to be banned from prescribing branded statins

Generics/News | Posted 19/08/2011

General Practitioners (GPs) in Cambridgeshire, UK, have been told by the national health service (NHS) that they are considering proposals to ban prescribing of branded statins in favour of cheaper generic alternatives according to a report in Pulse.

Benefits of generics called into question

Generics/Research | Posted 12/08/2011

The benefits associated with generic prescription drugs have been called into question in an article published in the British Medical Journal (BMJ) [1].

UK Government sues Servier for generic blocking

Generics/News | Posted 12/08/2011

The UK’s Health Secretary, Mr Andrew Lansley, has issued a GBP 220 million (Euros 246 million; US$360 million) lawsuit against French drug company Servier for allegedly ‘abusing’ its dominant position and delaying rivals from launching generic versions of its angiotensin-converting enzyme inhibitor, perindopril (Coversyl).

Epilepsy: medical concerns of prescribing generics

Generics/Research | Posted 12/08/2011

Generic economics

Generic medications are generally cheaper than their branded product counterparts and so prescribing these is encouraged as a cost-containment strategy in the management of healthcare resources. Encouraging the use of generic drugs is widely considered to be the most simple and effective way of reducing medication expenditure.

Factors that influence generic drug use

Generics/Research | Posted 05/08/2011

Increasing efforts to influence both the prescriber and patient factors involved in determining the type of initial prescription may benefit everyone involved in paying for medications to get the most cost-effective treatment for their condition.

Market share of generics set to rise as blockbuster patents end

Generics/General | Posted 05/08/2011

Sales of generic drugs across Europe are expected to grow by 63% in the next three years, mainly because the patents of nine major blockbuster drugs are due to run out [1].

Influence these two factors and the use of generics will increase

Generics/Research | Posted 05/08/2011

According to Assistant Professor William Shrank of Harvard Medical School, Boston, USA, we may be able to increase the use of generic alternatives over brand-name medications if we influence the following two factors: communication about generics between patients and their physicians or pharmacists and the patients’ comfort with generic substitution.

Domestic Indian market spawns generic agreements

Generics/News | Posted 29/07/2011

India’s population is growing rapidly—as is its economy—creating a large middle class with the resources to afford western medicines. This fact has seen a spate of western companies stepping forward to make agreements with Indian generics manufacturers in order to get a foothold in this developing market.

TRIPS and access to essential medicines

Generics/General | Posted 29/07/2011

A large number of people in the world cannot afford the basic necessities of life, which include access to essential medicines. Policies to encourage generic medicines in poorer countries may go some way to making essential medicines available for all, however, global intellectual property agreements may hinder these efforts.

US drug shortages – FDA may hinder, but APP may help

Generics/News | Posted 08/07/2011

Drug shortages are at a record high, and some blame the policies of the FDA for causing some of these. However, good news is on the horizon as US drugmaker APP Pharmaceuticals has decided to boost its manufacturing capacity for injectable generic drugs. This could help to fight against the growing list of drug shortages reported by the FDA.