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Emerging Opportunities in Controlled-Release Generic Drugs
Espicom Business Intelligence Ltd, Aug 2009, Pages: 128
From emerging specialist companies to established generic producers, alternative drug delivery technologies are increasingly being seen as a route to a competitive edge in the generics industry.
While controlled-release products have traditionally been developed towards the patent-expiry, companies are now beginning to look at controlled-release delivery earlier in the product life-cycle and, in some cases, are launching immediate- and controlled-release versions of new drugs to address the differing needs of patients.
A number of significant controlled-release drugs - some of them blockbusters - will lose patent protection in the medium term. This has led to increased interest from a range of companies vying for a share of the controlled-release generics market.
Fewer competitors, higher margins
It’s an attractive area: due to the significant technical barriers to the development of controlled-release drugs, they will generally have fewer competitors in the marketplace and, therefore, will attract higher prices and greater revenue opportunities than the highly competitive instant-release formulations.
A US$15 billion sector
The controlled-release drugs reviewed in this report had combined sales of more than US$15 billion in 2008. While the majority of these have patent protection for the controlled-release formulation, the validity of these patents is often the subject of litigation, particularly in the US where companies frequently file Paragraph IV certifications under the Hatch-Waxman act. In some cases, these legal challenges result in agreements between generic companies and originators, allowing the limited introduction of generics some years prior to patent expiry.
Identify key product opportunities, patent status and the activities of companies competing across all delivery platforms in this rapidly-developing growth area with this new 125+ page report:
Assess the current position and future potential of 30 CR therapies in key therapy areas
Evaluate the activities of 13 companies active in the field
Review the sector's position in the context of the broader generic market
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