Recent Developments in Generics

Last updated January 11, 2011. For more information contact Ed Thwaite.

• Ben Venue/Bedford (a Boehringer Ingelheim generic injectable subsidiary) has big manufacturing problems with the FDA. It had to stop manufacturing at its Bedford, Ohio plant. And cannot supply BMS with an important oncology drug, Doxil.
• Generic ANDA approvals for the full year of 2011 lagged behind the prior 5 years.
• Momenta has teamed up with Baxter to develop generic biosimilars.
• Ranbaxy settled its cGMP/manufacturing issues with the FDA. It will have to pay $500 million, and had to sign a "consent decree".
• Teva and Pfizer have been sued by Walgreen's and others for a supposed "pay-to-delay" deal relating to Effexor LR.
• Teva lost their bid to have Plan B (emergency contraceptive) approved for use without prescription by females under the age of 17.
• Teva reached an agreement with Bayer regarding their patent challenge to Levita. No details are available as to when their generic launch can occur.
• Watson has teamed up with Amgen to develop generic biosimilars.