FDA Refuses Approval To Generics Of Pfizer Drug, Except Mylan

Includes: MYL, PFE
by: Aaron F. Barkoff

Ever since March 22, when the Federal Circuit invalidated Pfizer's (NYSE:PFE) patent on Norvasc (amlodipine besylate), Pfizer, Mylan (NASDAQ:MYL) and other ANDA filers have been scrambling.

On March 23, Mylan, the first ANDA filer, launched its generic version of Norvasc and Pfizer responded by launching an authorized generic. On March 26, Mylan filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from approving any other ANDAs for generic Norvasc until September.

FDA asked all interested parties for their views on Pfizer's pediatric exclusivity and Mylan's 180-day exclusivity, and on April 5 FDA published those comments.

As ordered by the district court, FDA reached a decision regarding Norvasc exclusivity yesterday. According to FDA's notice (pdf file) and letter (pdf file), which was addressed to amlodipine besylate ANDA applicants and submitted to the court:

In sum, FDA has concluded:

  • All of the unapproved ANDAs are currently blocked by Pfizer's pediatric exclusivity.
  • If and when the mandate effectuating the panel's March 22 decision issues in the Apotex case, Apotex's ANDA will not be blocked by Pfizer's pediatric exclusivity.
  • FDA cannot determine on the current record whether other ANDAs will continue to be blocked by pediatric exclusivity at that time.
  • Mylan's 180-day marketing exclusivity terminated when the patent expired.
  • In its April 4 comments to FDA, Pfizer argued that FDA could not approve any other amlodipine ANDAs until the Federal Circuit issues a mandate from its March 22 decision, since only then would the decision become effective. Apparently, FDA agrees.

    A mandate cannot issue until disposition of a petition for rehearing or rehearing en banc, which Pfizer timely filed on April 5 (click here for Pfizer's petition (pdf file)). If Pfizer's petition is granted, the mandate won't issue until the Federal Circuit makes a final decision following rehearing. If Pfizer's petition is denied, the Federal Circuit will issue the mandate seven days after the decision to deny the petition.

    Thus, Mylan's 180-day exclusivity period ended just two days after it began, but Mylan retains de facto generic exclusivity by virtue of Pfizer's pediatric exclusivity. Mylan is riding Pfizer's coat-tails as the only supplier of generic Norvasc - at least until Pfizer's pediatric exclusivity expires.

    Thanks to Kurt Karst of FDA Law Blog for passing along the news.