UPDATED: AstraZeneca's Pulmicort gets temporary reprieve as judge halts generics launch

Courtesy of Kaiser Permanente

AstraZeneca's ($AZN) respiratory aspirations just took a hit. While it guns for a lead in the field, it may have to do so without much help from asthma med Pulmicort, which lost a patent in U.S. federal court Friday.

The U.S. District Court for the District of New Jersey has deemed the drug's '834 patent invalid, paving the way for Actavis ($ACT) to release its own generic version of the blockbuster. That patent had been good through 2018--with pediatric exclusivity extending into 2019--and had been warding off knockoff competition aside from Teva's ($TEVA) authorized generic.

AstraZeneca doesn't much like that decision. The company "strongly disagrees" with the ruling, U.S. president Paul Hudson said in a statement, and it's requested an injunction against the Actavis knockoff. The company won a temporary reprieve, pending appeal, blocking Actavis' sales of the product for now, the Dublin drugmaker said Wednesday.

The British pharma has plenty at stake; Pulmicort revenues, combined with Teva's generic sales of the treatment, hit $1.1. billion in the 12 months ended June 30, 2014, Actavis says. But AstraZeneca, which has been building up its respiratory stable, has other meds helping it contend for the crown. Earlier this month, it agreed to pay $600 million up front for Actavis' respiratory meds, Tudorza Pressair and Daliresp--a deal that followed a similar buy with Spain's Almirall last year.

And despite hot competition for aging giant Symbicort, that AZ med has managed to steal a piece of the pie from Glaxo's Advair, too. AZ has taken the fight to pharmacy benefits managers, where Symbicort has been jockeying with Advair for favored position on key U.S. formularies.

But GSK, whose Advair sales slide has triggered serious layoffs and a fair share of consternation at the company, is fighting back, both with Advair and a host of newcomer lung drugs. And two of those--Breo and Anoro--are finally gathering steam in the market to overcome their slow starts, CEO Andrew Witty said recently.

Access is in part to thank for that recent success, as Witty told investors on a company conference call. And in that department, Glaxo has its rivals beat: Compared with "our biggest competitor in this marketplace, we have about a 20 percentage point advantage of access ... which is quite a big flip-around from last year," he said.

- read AZ's release
- read Actavis' release

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