Copaxone 40mg Generic At-Risk Launch Anticipated As Soon As February
Teva is seeking injunction to block generic entry after court rules four patents on the three-times-a-week dosage are invalid; analysts expect launch soon after FDA approves an ANDA, with Sandoz/Momenta generic the likely leader.
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Fate Of Copaxone 40mg Patents Depends On Courts After PTAB Rejection
Teva awaits district court ruling on patents covering the three-times-a-week dosage and is appealing the Patent Trial & Appeal Board’s findings of unpatentability.
DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.
What Would US FDA Do If Supreme Court Eliminates Or Curtails Chevron Deference?
Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.