Andrx Expects Concerta "Authorized" Generic From J&J's Patriot Unit, Third Party
This article was originally published in The Pink Sheet Daily
In a citizen petition, Andrx requests FDA re-evaluate its policy concerning the marketing of "authorized" generic versions of brand drugs. Petition urges the agency to seek formal input from FTC and Justice Department on potential anticompetitive effects.
You may also be interested in...
Patent litigation between Par and J&J is pending in Newark, N.J. federal court. Par received ANDA approval for the tramadol/acetaminophen combination the same day the 30-month stay expired.
Any reduction in the economic value of an ANDA first-filer's product during the 180-day exclusivity period "does not rise to the level of absurdity" requiring the court to look beyond the "plain language" of the FD&C Act, D.C. Judge Walton rules. Teva is appealing the decision.
FDA will seriously consider Johnson & Johnson's citizen petition filed in an effort to block approval of generic Concerta, the company says