Reports

Generic applications in the EU, patents and exclusivity

Home/Reports | Posted 01/07/2011

Types of protection on the originator molecule that have to be taken into account by generic drug manufacturers when filing applications for generic drugs in the EU include the following:

patents at the time of marketing
supplementary protection certificates at the time of marketing
data/regulatory exclusivity at the time of regulatory submission
market exclusivity at the time of marketing.

Big Pharma and the generics industry

Home/Reports | Posted 24/06/2011

What with growth in the global pharmaceutical market slowing and even stabilising and the impending ‘patent cliff’ looming, Big Pharma needs to look for other options.

Impact of healthcare reforms

Home/Reports | Posted 29/07/2011

Even though global pharmaceutical market growth has stabilised, it still means a rising medicines bill. The global pharmaceutical market is expected to add nearly US$300 billion through 2014, topping US$1.1 trillion [1].

The growth in the generics industry

Home/Reports | Posted 08/07/2011

During 2010 there was unprecedented activity in the pricing and market access landscape, much of which has aided the growth in the generics industry during 2010. This activity occurred across three broad themes:

Patent cliff and the generics industry

Home/Reports | Posted 01/07/2011

An estimated US$186 billion in sales revenues of patent-protected medicines is likely to be exposed to generic competition between now and 2016 [1].

A sustainable generics industry in the EU

Home/Reports | Posted 19/08/2011

Today, generic medicines play an essential role in treating disease by increasing the accessibility and affordability of modern day pharmaceuticals. It is therefore essential to ensure that generics can enter the market as soon as possible after patent and data exclusivity protections expire and compete effectively in order to maintain a sustainable generics industry.

Generics grab 80% share of US market and fill 78% of prescriptions

Home/Reports | Posted 13/05/2011

As more brand-name drugs lose patent protection, use of less expensive generics continues to rise. A new report, published in April 2011 by IMS Health, shows a slowdown in US spending on drugs, but an increase in the percentage of prescriptions filled by generics and a faster rate of capture of market share by generics after patent expiry.

Global pharmaceutical growth predicted to be 5–7% in 2011

Home/Reports | Posted 07/01/2011

According to IMS Health, global drug sales will rise in 2011 despite patent losses. Although patent expirations and limits on drug spending can hamper growth of drug sales in developed countries, global pharmaceutical sales are nonetheless expected to grow 5–7% in 2011, compared with 4–5% growth in 2010, according to an annual forecast by IMS Health.

The EU and rational use of medicines

Home/Reports | Posted 29/04/2011

A report produced by the Gesundheit Österreich GmbH / Österreichisches Bundesinstitut für Gesundheitswesen (GÖG/ÖBIG – Austrian Health Institute) surveyed measures for promoting the rational use of medicines in the 27 EU Member States.

The Netherlands and rational use of medicines

Home/Reports | Posted 15/04/2011

The Netherlands was studied in detail in a report produced by the Gesundheit Österreich GmbH / Österreichisches Bundesinstitut für Gesundheitswesen (GÖG/ÖBIG – Austrian Health Institute). The report surveyed measures for promoting the rational use of medicines in the 27 EU Member States.