Future for Sandoz’s Generic Glaucoma Drug May Be Less Cloudy

Novartis AG’s generics arm, Sandoz Inc., could be getting closer to being able to launch a generic version of Allergan Plc’s blockbuster glaucoma drug Combigan.

A Dec. 22 nonprecedential ruling from the U.S. Court of Appeals for the Federal Circuit reversed a 2016 district court decision that blocked Sandoz from selling its proposed generic product until April 2022.

But don’t count Allergan out just yet. The still has several defensive moves up its sleeve to protect the lucrative Combigan franchise from generic competition.

Allergan plans to file petitions for rehearing of the appeals court decision and also has asserted a new Orange Book patent against Sandoz’s generic version of Combigan, the company told Bloomberg Law.

The Orange Book is a Food and Drug Administration listing of patents that branded drugmakers claim cover their products and is formally titled “Approved Drug Products with Therapeutic Equivalence Evaluations.”

The current federal district court’s injunction preventing final approval and launch of the Sandoz product isn’t likely to be lifted before the appeals court decides whether to rehear the case, Allergan said.

In addition, because Allergan is suing Sandoz over a different Combigan patent in federal district court in New Jersey and that case has yet to be decided, Allergan said, it doesn’t believe the appeals court ruling will “result in the market formation for a generic Combigan product.”

Allergan Plc is headquartered in Dublin. Novartis AG, which owns Princeton, N.J.-based Sandoz, is based in Basel, Switzerland.

The case is Allergan Sales, LLC v. Sandoz, Inc., Fed. Cir., No. 17-1499, nonprecedential 12/22/17.

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