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All Change in the US Pharma Market?
Espicom Business Intelligence Ltd, June 2008, Pages: 186
The rise of generics, products at risk and defence strategies
The figures speak for themselves. Of the 150 products detailed in this report, 24 faced generic competition in 2006. This rose to 35 in 2007 and 49 in 2008. By 2012, this will have risen to 73 products on a conservative estimate, and possibly as many as 91.
When is patent protection not patent protection?
Often when it is a pharmaceutical product. At one time the extensive use of patents safeguarded a branded company’s product portfolio against generic competition. Increasingly, however, the fiercely competitive US generic sector has pursued an aggressive policy of earlier and earlier challenges. Compelled by the need for new revenues in the world’s largest pharmaceutical market, and often with the tacit encouragement of cost-conscious health payers, the sector has been buoyed by many successful legal and regulatory decisions well ahead of patent expiry.
In response, the branded industry has employed a range of mechanisms to stop or limit the generics companies’ ambitions - with varying success. Traditional defence of right through litigation is a strategy that has been joined by the rise of authorised generics, incremental innovation and the introduction of combination therapies.
The issue has never been more critical. Over the next 5 years over 73 products - including the current leading therapies - will face generic competition with a significant influence on sales, profitability and R&D investment.
A unique business analysis of this crucial issue
At this critical stage, everyone - be they a branded manufacturer, generics company or commercial investor - needs to understand in detail which products are affected and the mounting effect it will have on the leading pharmaceutical companies. This new 188-page report, written by leading generic market analyst Andy Crofts, compares and contrasts at the product level the current situation and looks at how the market will develop to 2012. Packed with facts, figures and novel analysis, this report is essential reading for all senior executives throughout the industry. Evaluating risk levels
A generic version of a product does not necessarily mean widespread generic availability. For example, we estimate that 43 of the 150 products analysed in this report will face limited competition by 2012. ‘Limited’ indicates that generics will appear by 2012, but will have a muted impact. This could be due to expiry occurring right at the end of the period, a small number of entrants due to 180-day exclusivity or otherwise, generic availability of an older version than the marketed brand, or limited appeal for generics on therapeutic grounds. Is attack the best form of defence?
In the face of ANDA applications made well in advance of significant patent expiry the industry has pursued a wide range of defence strategies including incremental development, reformulation, citizens petitions and deals.
The obvious defence is to sue for patent infringement, but US courts have proved variable in their support of the branded industry IP claims and lengthy and costly litigation has many downsides. At the other end of the scale, companies have sought collaboration as the way forward.
A case in point...Authorised Generics
Several originator companies like to do a deal with a generic company to issue an authorised generic once the branded version loses exclusivity. This tends to be more common when generic competition is launched ‘at risk’, or where the original is a major seller. Such deals do little to preserve revenues for the originator, although they will take a royalty. The primary aim is to eat into the 180-day exclusivity of the first generic filer, reducing their sales, profits and maybe their incentive to develop such challenges in future. The authorised generic can be launched whenever the patent holder agrees, and does not have to wait until the expiry of the 180-day period. Generic companies finding themselves on the wrong side of this development have attempted to force the FDA to refuse marketing approval for such products, but without success.
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