CELG: Patent Challenge To Revlimid Could Shorten Exclusivity Period From 2026 To 2019
Analysts at Jefferies & Co reiterate their "buy" rating on Celgene Corp (NASDAQ: CELG). The target price for CELG is set to $64.
Jefferies & Co says, “Celgene's Revlimid became eligible for a generic challenge since December 27, 2009, so today's Paragraph IV filing should come as no surprise to the Street. Revlimid is currently protected under a composition of matter patent that expires in 2019, as well as patents that cover the risk management program (2018-2020) and crystal polymorphs of Revlimid (2026). Because of the types of patents that expire beyond 2019 and the mixed track record of success with crystal polymorph patents (many of which are circumvented by generics that discover an alternate crystal polymorph not covered by the innovator patent), there is uncertainty on the exclusivity period for Revlimid beyond 2019. We expect the impact of this challenge would be exacerbated if the generic challenger is soon identified as one with deep generic expertise. We assume that the focus of the Paragraph IV challenge is the 2026 crystal polymorph patent.”
“Lenalidomide (Revlimid, 25mg capsules) appeared on a list of Paragraph IV certifications posted to the FDA website on August 23, 2010. An unnamed generic manufacturer filed a Paragraph IV certification with the FDA on July 12 as an assertion that a patent listed in the Orange Book is invalid or unenforceable, or will not be infringed upon by the generic product. We expect CELG will file litigation within 45-days of notification to trigger a 30-month Hatch-Waxman stay,” the analysts add.
