Ranbaxy Exclusivity Implosion Pushes Valcyte Generics Towards Launch; Nexium Remains ‘Very Hazy’
This article was originally published in PharmAsia News
Executive Summary
FDA rescinds Ranbaxy’s esomeprazole and valganciclovir ANDA tentative approvals because of GMP compliance issues; firm loses its 180-day marketing exclusivity for valganciclovir but not for esomeprazole.
You may also be interested in...
Nexium Patent Battle Could Switch To Generic Vs. Generic Fight
Teva obtains a license from AstraZeneca to begin marketing generic Nexium in May 2014 but may be delayed by Ranbaxy's exclusivity; Teva also withdraws appeal of ruling that upheld Merck's Singulair patent.
AstraZeneca Settles Nexium Case With Ranbaxy; Can It Delay Other Generics?
AstraZeneca expects its settlement agreement with Ranbaxy ending Nexium (esomeprazole) patent infringement litigation will win a nod of approval from the Federal Trade Commission
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.