Abstract
The US Food and Drug Administration (FDA) has extended patent protection, for paediatric studies, to several of the largest drug companies for an extra six months. The FDA's paediatric exclusivity provision was established in 1997 to provide marketing incentives to manufacturers who conduct studies of drugs in children. Pharmaceutical giants GlaxoSmithKline will benefit from this six-month exclusivity extension for three of their products, Ziagen (abacavir), Epivir (lamivudine) and Zantac (ranitidine). Abbott Laboratories received protection for Calcijex (calcitriol), Ultiva (remifentanil) and Ultane (sevoflurane). Other companies that will do well by this ruling are Johnson & Johnson, American Home Products, Eli Lilley and Merck. This has generated criticism from companies producing generic drugs that account for ∼40% of the US prescription-market, who feel that the FDA's ruling gives the brand companies an unfair advantage. HN
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
