Generics

What is ‘tentative approval’ and how does it affect generics?

Generics/General | Posted 10/09/2010

Tentative approval by the FDA enables generics access to poor nations under a US initiative, which allows sale of generics to treat conditions where there is a significant public health impact, even though the originator drugs are still under patent protection.

Pharma price-fixing under renewed investigation

Generics/General | Posted 10/09/2010

Some of the world’s biggest drug companies are having once again to face up to price-fixing allegations thanks to the Supreme Court of California. These allegations were dismissed by a lower court two years ago. The suit claims that the 18 drug manufacturers, including Pfizer, GlaxoSmithKline, AstraZeneca, Merck and Eli Lilly amongst others, not only set artificially high prices, but also conspired to keep cheaper Canadian drugs off the US market and to stave off generic competitors.

Drug recalls and generic medicines

Generics/General | Posted 03/09/2010

In 2009 there were a record number of drug recalls according to Health Reform Watch. There were an amazing 1,742 drug recalls in 2009 compared to 426 in 2008.

International trends in generics: India

Generics/General | Posted 03/09/2010

South Africa, home to 5.7 million HIV-positive people – more than any other country in the world – gives AIDS patients free drugs, most of which are generics that come from India. This is just one country, but representative of many that are keen to buy low-priced generic medicines from India. So much so that India now produces a quarter of the world’s generic medicines.

Can we have our cake and eat it?

Generics/Research | Posted 03/09/2010

Managing the cost of pharmaceutical expenditure is entirely the competence of individual EU Member States. As a result, Europe has developed into a patchwork of different systems of pharmaceutical pricing and reimbursement.

International trends in generics: the EU

Generics/Research | Posted 30/08/2010

Few studies have conducted an international price comparison of generic medicines as it is hard to access comparable data. A 2007 study by Prof. Dr. Steven Simoens examined national pricing policies in some EU countries and related them to generics prices (see Table 1).

Sun Pharma adds generic tamsulosin and rivastigmine to portfolio

Generics/News | Posted 13/08/2010

Sun Pharma is gathering speed with a barrage of generic versions recently coming onto the market and with an extensive pipeline on the way. The latest generics to come out of the company include versions of tamsulosin and rivastigmine.

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.

Astra Zeneca losing generic esomeprazole battle

Generics/News | Posted 02/07/2010

On 17 June 2010, AstraZeneca announced that its efforts in Canada to stop the launch of a generic version of its patented, stomach-acid-relief drug Nexium (esomeprazole), were rejected by the Canadian court.