US Court stops Apotex from selling Pulmicort generic

AstraZeneca wins the case to block sales of budesonide copies in US, at least till 27 April 2009.

Apotex’ cannot sell generic version of AstraZeneca’s asthma drug Pulmicort Respules (budesonide inhalation suspension) in the US, at least for some time.

AstraZeneca Plc won a bid to temporarily block Apotex Inc. from selling copies of the asthma drug Pulmicort Respules as a US District Judge  issued a restraining order to block the Toronto- based Apotex’s sales of the drug.

The restraining order will remain in effect until at least April 27, when the Court will consider whether Apotex’s copy should be kept off the market until the underlying patent case is heard.

U.S. Food and Drug Administration gave Apotex approval on March 30 to sell its version of Pulmicort repsules. AstraZeneca sued the next day, seeking to block sales until patents expire. The patents on Pulmicort with pediatric exclusivity is extending to 2019 is set to expire in 2019.

AstraZeneca,UK’s second-largest pharma company, had US Pulmicort sales of $982 million last year. Sales of the Pulmicort respules accounted for about 90 percent of that total, the company said Jan. 29.

As a strategy to keep generic versions of Pulmicort off the market, AstraZeneca reached an agreement Teva Pharmaceutical Industries Ltd. In an agreement reached between AstraZeneca and the Israeli Teva Pharma in November last year, the latter had agreed not to sell its copy of  Pulmicort Respules until Dec. 15.

The District Court had, earlier, forbade Teva,  from selling its generic version. That time, while granting a judgment favouring AstraZeneca, the Court had noted that AstraZeneca faced “immediate and irreparable harm” if the temporary ban wasn’t imposed.

However, AstraZeneca settled the dispute out of court the following week with Teva, the world’s largest maker of generic drugs.

Following the US FDA approval in Nov 18 Teva entered the market briefly before the Court ruling. AstraZeneca said that, as a result, U.S. sales of Pulmicort Respules fell 18 percent in the fourth quarter.

Teva was allowed to continue selling the generic Pulmicort that had already been shipped, and the copies accounted for 40 percent of all budesonide inhalation suspension sales in December.

The case is AstraZeneca LP. V. Apotex Inc., 09cv1518, U.S. District Court, District of New Jersey (Camden).

What is Pulmicort Respsules?

Pulmicort repsules contains budesonide, the active ingredient. Budesonide is an anti-inflammatory steroid medication. Inhaled on a regular basis, Pulmicort helps prevent asthma attacks.

Pulmicort Respules are prescribed for children 12 months to 8 years of age. They are given by nebulizer (a device that produces a fine spray).

Adults and children over 6 can use another form of budesonide, Pulmicort Turbuhaler, that’s taken with an inhaler. Side effects of Pulmicort include: abdominal pain, conjunctivitis (pinkeye), cough, diarrhea, ear infection or inflammation, fever, fungal infection in mouth, headache, nasal or sinus inflammation, nosebleed, pain, rash, respiratory infection, stomach or intestinal inflammation, throat inflammation, viral infection, vomiting, wheezing etc.