kate_sept2004 / iStockphoto.com
With several major drugs set to face generic or biosimilar competition as patent protection expires, LSIPR analyses how well prepared their manufacturers are and how badly their sales may be affected.
For consumers, the prospect of drugs going off-patent may well be a blessing. But for the pharmaceutical companies behind the branded medication, the onslaught of generic competition is seemingly far from positive.
One study suggested that the overall cost of developing a prescription drug is $2.6 billion, from research to marketing approval (“Innovation in the pharmaceutical industry: new estimates of R&D costs”, Tufts Center for the Study of Drug Development, published in the Journal of Health Economics, 2016).
Sanya Sukduang, partner at Finnegan Henderson Farabow Garrett & Dunner, says that America’s Hatch-Waxman Act recognises the significant investment that pharmaceuticals inject into developing new drugs and provide an incentive, through a range of regulatory and statutory provisions (such as market exclusivity and patent grants), for companies to continue developing novel therapies.
You need a subscription to continue reading this content.
To access the full archive, digital magazines and special reports you will need to take out a paid subscription.
News stories up to a week old and feature articles on the day of publication are accessible with a BASIC FREE ACCOUNT.
If you have already subscribed please login.
If you have any technical issues please email tech support.
For access to the complete website, archive, and to receive print publications, choose '12 MONTH SUBSCRIPTION'. For a free, two-week trial with full access, select ‘TWO WEEK FREE TRIAL’; and for basic access to the latest news on the website and weekly email news alerts choose the 'BASIC FREE ACCOUNT' registration.
Generic competition, Lyrica, Pfizer, Cialis, Eli Lilly, Neulasta, Amgen, Rituxan, Roche, pharmaceutical sales, research and development, patent protection