Mylan Denied Final Generic Nexium Approval

The FDA gave tentative approval to Mylan’s ANDA for a generic Nexium, but denied final approval due to lasting exclusivity protections — almost guaranteeing Teva the only generic version of the blockbuster heartburn drug on the market for months to come.

In a Feb. 4 letter to Mylan, the FDA said it can’t give final approval until after Aug. 3, when Nexium’s (esomeprazole) exclusivity for pediatric indications expires. The agency asked Mylan to resubmit its request for final approval 90 days prior to that date.

The reason Teva can launch while Mylan can’t is most likely the result of an agreement by AstraZeneca to waive pediatric exclusivity during patent challenge litigation with Teva.

Mylan’s denial leaves Teva the only company with an approved ANDA for Nexium, although multiple other generic filers against the drug could potentially be approved, especially after Ranbaxy was stripped of its authorization and first-filer rights to a generic Nexium over GMP violations at its India plants.

Ranbaxy is still challenging that decision. Its manufacturing woes have significantly delayed entry of a generic Nexium, which could have hit shelves as early as May 2014. The delay has proven a boon to NDA holder AstraZeneca’s coffers. The brandmaker raked in $832 million in the 2014 fourth quarter alone and $3.6 billion for the year.

Teva said in a call with investors last week that launch of its generic Nexium was imminent. The only reason Teva hasn’t already launched after its Ivax Pharmaceuticals subsidiary received the greenlight last month is because AstraZeneca changed the product label right before generic approval, said Sigurdur Olafsson, president and CEO of global generics. That forced Teva to change its label.

Mylan did not respond to a request for comment by press time.

Read the FDA’s letter to Mylan at www.fdanews.com/02-11-15-MylanNexiumGeneric.pdf. — Bryan Koenig