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When faced with competition, suddenly drug makers can produce generics

Submitted by on Wednesday, 19 November 2008 2 Comments

Once in a while, I’ll run across something so confusing I’m not sure who the good guys are.

Like this morning when I saw that the Food and Drug Administration has approved a generic version of the children’s asthma medication Pulmicort Respules.

Turns out, the good guys producing the generic are accusing of being the bad guys ripping off a patent. But then the good guys holding the patent suddenly discover that, yes, they can manufacture a generic and still make money. Which makes me think they were being meanies all along.

Pulmicort’s not a medication we use a lot — for general purposes, Flovent works fine for us, plus it’s easier to administer. When Big Guy’s really in the weeds like he was when wildfires hit last summer, though, we switch to Pulmicort for a few days.

Flovent also was less expensive, because my former insurance company covered it with a $25 name-brand co-pay. Pulmicort wasn’t on the list bean-counters compile of medications they believe you need, so it cost $60. See? We already have managed health care — managed by accountants, that is.

The full retail price of Pulmicort, though, runs around $300 a month. (Asthma: a perfectly manageable condition if you can afford to manage it.) So in my current temporary uninsured state, I cheered the arrival of a generic.

But it’s way more complicated than that.

  • The FDA gave approval for generic Pulmicort to Teva Pharmaceuticals, an Israeli company.
  • AstraZeneca, the British company that holds the patent for the brand name, has sued Teva in U.S. District Court to block the generic.
  • Hours after the FDA approval, AstraZeneca announced an agreement to produce its own generic, at the same time asking the judge in the patent case to block Teva’s version.
  • Teva has played “patent, patent who’s got the patent” with other medications — Allegra, Zithromax, and Singulair to name a few.

I do not condone ripping off intellectual property, if that is indeed what Teva is doing. The company’s argument, loosely translated, appears to be “we’re not using your recipe; we’re just using similar ingredients.”

In some cases, such as one involving Abbott’s cholesterol drug Tricor, Teva has sued in turn, claiming the big manufacturers are violating antitrust laws and frustrating efforts to bring cheaper generics to market.

The legalities are for judges to decide. Let me just say this, though, and I hope the crowd that defends drug patents with the half life of plutonium is listening.

In the cases of Zithromax, Allergra and now Pulmicort the original patent-holders put generics into production quickly after Teva won approval for generics.

If AstraZeneca can produce generic Pulmicort today without causing the company to collapse, then it could have done so yesterday. Or last week. Or last year. And more parents would have been able to afford wheeze-free days for their kids.

Anyone else feel a gouging pain in the vicinity of the wallet?

Copyright 2008 Debra Legg. All rights reserved.

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  • Jennifer Vetter said:

    Thank you! I’ve been complaining to my daughter’s Dr about the cost of these meds. We pay a $45 co pay for a box of Pulmicort Respules. Once the foil package is opened, all the respules must be used within two weeks, or thrown away. My daughter only needs the med occasionally, so we end up tossing most of it. It’s such a waste. I’ll be keeping my eyes open for generic versions of Xopenex too!

    Thank you for posting this.

  • Debra said:

    PLUS even the unopened Pulmicort expires quickly. I just checked the boxes I bought in late June and they died last month. Which makes me think of using words I don’t say in front of the guys. :) I can’t wait for the generic to go into production.

    Ay, Xopenex my insurance bean counters would never approve, even though my pediatrician put in calls and begged them because it’s a far superior medication. It was $100 a week. It rapidly reached to the point of not affordable, so I put him back on albuterol. That’s a special kind of joy when you’re dealing with a 2-year-old who’s already a wee bit on the temperamental side.

    Meanwhile, I have to figure out a better way to track this issue. I had no idea Singulair was going into generic production, and that’s another regular for us.