Generics

Teva brings another action against Mylan

Generics/News | Posted 03/12/2010

In October 2009, Teva Pharmaceutical Industries filed a lawsuit against Mylan for infringement of multiple patents, with respect to patents on its glatiramer acetate drug–Copaxone. The patents cover pharmaceutical compositions containing it, methods of using it and processes for making it. Those patents expire in May 2014 and September 2015. No trial date is scheduled.

What is the incremental cost-effectiveness ratio (ICER)?

Generics/General | Posted 03/12/2010

The incremental cost-effectiveness ratio (ICER) often comes up when talking about drug comparisons, but what is it and how does it relate to medicines?

Ranbaxy beats Teva to Alzheimer’s drug

Generics/News | Posted 26/11/2010

Aricept (donepezil hydrochloride), Eisai Pharmaceutical’s biggest selling drug, comes off patent in the US in November 2010. Thereafter donepezil hydrochloride may be sold as a generic drug. Teva has applied to sell donepezil, but the FDA granted Ranbaxy first access to the lucrative market in a letter dated 17 September 2010.

An ageing population: generics and biosimilars could be the solution

Generics/News | Posted 19/11/2010

On 17 October 2010 the European Generic Medicines Association (EGA) organised an event to discuss patient access to affordable treatments and healthcare sustainability in view of an increasingly ageing population.

Canadians pay almost twice as much as Americans for generics

Generics/Research | Posted 19/11/2010

A new study released on 13 October 2010 by the Canadian Fraser Institute finds that Canadians pay far higher prices, in fact almost double, for generic drugs than patients in the US.

Go Perrigo!

Generics/News | Posted 19/11/2010

Generic drug maker Perrigo has made it to Fortune magazine's top 100 fastest growing companies in the US. Fortune is a business magazine especially known for ranking companies by revenue. So there is some rejoicing in Michigan as the local hero has now received national acclaim.

FDA user fees for assessing generic drugs

Generics/News | Posted 12/11/2010

The FDA is beginning a long-awaited attempt to create a system of user fees for assessing generic drugs. The US agency has a backlog of more than 2,000 products to review and has been short of funds for years. But things are never straightforward…

Slow response to internet sales of fake pharmaceuticals

Generics/General | Posted 08/11/2010

If you are reading this news online, you are surely aware that many sites claim to sell “generic medicines” “without prescription” over the internet. Police and authorities have noticed as well, but do not know how best to tackle these lucrative scams.

Teva continues to expand

Generics/News | Posted 08/11/2010

The world's largest generic pharmaceutical company, Israeli-based Teva Pharmaceutical Industries, is investing Euros 42 million to expand its production plant in Stouffville, Canada. At the same time Ontario is providing a Euros 4.8-million grant to Teva Canada, which will retain 182 high-skilled workers and hire 20 new employees.

Comparison of biosimilar and branded vancomycin

Generics/Research | Posted 29/10/2010

Despite demonstrating pharmacological equivalence, researchers have found biosimilar vancomycin exhibited inferior antimicrobial activity compared with the branded product.

Teva challenged over 180-day marketing exclusivity

Generics/News | Posted 29/10/2010

Canadian generics’ manufacturer Apotex has asked the US Supreme Court to hear a case that could have a lasting impact on how marketing exclusivity is awarded to generic-drug manufacturers by the FDA.

Japan’s generics sector set to grow

Generics/General | Posted 29/10/2010

Japan is currently the world’s second largest pharmaceutical market, with annual sales of approximately Yen 8,850 billion. Around 8% of its prescription drug sales (20% in sales volume) are generics.

Tentative approval for more new Sun Pharma generics

Generics/General | Posted 20/10/2010

Sun Pharma is not slowing down with the number of new generic medication introductions. The latest generics to come out of the company include versions of riluzole hydrochloride and rosuvastatin.

Incentives to use generic medicines

Generics/Research | Posted 01/10/2010

A variety of financial and non-financial incentives are intended to encourage generic prescribing. Physician budgets are used by Germany and UK and seem to encourage generic prescribing. Assistance in terms of electronic prescribing, medicines databases, audit and feedback on prescribing data, guidelines and formularies tend to be voluntary and have a limited impact. Denmark and the UK teach medical students to prescribe by INN rather than brand name. Portugal requires prescription by INN if a generic product exists. Physicians see this as a restriction on their prescribing freedom in Belgium and France and resist such moves.

An industry view of generic manufacturing

Generics/Research | Posted 01/10/2010

Research and development of innovative medicines are becoming more challenging, with only 29 medicines with new chemical entities launched in 2006. The dwindling pipeline of new innovative medicines reduces the number of new chemical entities that can be developed when patents on innovative medicines expire in the future. Manufacturers of innovative medicines attempt to extend the period of patent protection by either launching a new dosage, a sustained-release version, a new indication, a single isomer version or a combination medicine. These strategies delay the market entry of generic medicines. As generic competition primarily takes place in the market for prescription medicines, some manufacturers of originator medicines have switched their medicines from prescription to over-the-counter status, e.g. simvastatin 10 mg in UK.

Pricing strategies in generic medicines

Generics/Research | Posted 01/10/2010

Eighty two per cent of countries impose pricing regulation while 18% opt for free market competition to control prices. Of the countries that regulate prices, 36% set the price of generic medicines at a predetermined percentage below the originator price. For instance, the minimum price difference between originator and generic medicines was 20% in Italy in 2004. In 21% of countries, the generic medicine price is based on the average price of medicines in a selection of countries. Other mechanisms used to set generic medicine prices are a maximum price (19% of countries) and a negotiable price (12% of countries).

Generics in The Netherlands

Generics/General | Posted 01/10/2010

The market for generic medicines in The Netherlands ambulatory health care is developing, with more being used, more companies supplying generic medicines and prices tumbling. This is despite the restriction on the reimbursement of hypnotics and tranquilisers on the basic insurance from 1 January 2009. Reimbursement in this category fell by 25%, from Euros 612 million in 2008 to Euros 459 million in 2009.

Celgene and Natco in generic lenalidomide battle

Generics/News | Posted 24/09/2010

Indian generics’ manufacturer Natco Pharma (Natco) has filed an abbreviated new drug application (ANDA) with the FDA seeking approval to sell a generic version of Celgene Corporation’s (Celgene’s) flagship blood cancer drug Revlimid (lenalidomide), before its patent protection expires.

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.