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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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May 5, 2011

When Lipitor Goes Generic

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Posted by Derek

So, when Lipitor goes generic later this year, it's Ranbaxy that's going to step in and make the big bucks for a few months, right? Well. . .there's room to wonder. Ranbaxy has had some severe regulatory problems, and other companies are trying to see if they can use those to their advantage. Fortune magazine has more:

You'd think that in this era of generic-drug dominance, making the transition to a nonbranded version of Pfizer's vaunted cholesterol-fighting statin would be smooth, or at least controlled. And indeed, that's precisely how it seemed -- until just a few months ago. Now the process appears to have unraveled, leaving serious questions about who will make the cheaper form of Lipitor, whether the price will really drop, and most disturbing of all, whether patients will be able to trust that the medication is safe. . .

Comments (14) + TrackBacks (0) | Category: Regulatory Affairs


1. Still Scared of Dinosaurs on May 5, 2011 11:56 AM writes...

And yet the age of biosimilars is upon us. There are multiple cases of a company failing to recreate its own drug and yet somehow cost-conscious generics companies are going to pull it off?

"It could happen."
- Judy Tenuta

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2. patentgeek on May 5, 2011 12:11 PM writes...

One of those seeking to use Ranbaxy's problems to their advantage is Mylan. Their suit to force FDA to determine whether Ranbaxy had forfeited the 180-day exclusivity period was dismissed in DC District Court earlier this week (lack of subject matter jurisdiction). (Mylan Pharms. v. FDA and Ranbaxy Labs., No. 11-566-JEB (D.D.C. 2011)
More at

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3. DrSnowboard on May 5, 2011 12:21 PM writes...

But if we were misguided to follow this advice, show me the money.

Risk of disease correlates with increased age, who knew?

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4. anon the II on May 5, 2011 12:32 PM writes...

My sense is that this is all Pfizer PHUD, which they learned from IBM and Microsoft.

Phear, Uncertainty and Doubt.

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5. Anonymous on May 5, 2011 12:35 PM writes...

2: You have comma included in the link so it does not work.

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6. ex-Pfizerite on May 5, 2011 12:40 PM writes...

You need to remember that Pfizer has a major generic group called Greenstone, so will Pfizer launch its own generic before Ranbaxy and stuff the channels?

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7. lynn on May 5, 2011 12:51 PM writes...

I think Merck should manufacture and sell generic lipitor. Or combine it with zetia. :-)

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8. Nate on May 5, 2011 3:51 PM writes...

#6, I didn't think authorized generics (as greenstones) would be are allowed to play with the 180 day rule. But I could be wrong

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9. Matthew Herper on May 5, 2011 5:12 PM writes...

#6, I think Watson is making the authorized generic in this case. If Ranbaxy does not launch in time, Watson will still launch in November, I believe.

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10. ex-Pfizerite on May 5, 2011 7:12 PM writes...

With regard to 8 and 9 an authorized generic is not a generic because it does not have an ANDA but is sold as part of the branded drugs authorization. In theory Pfizer could sell an authorized generic tomorrow and Ranbaxy could do nothing about id absent an agreement in the settlement.

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11. Virgil on May 6, 2011 8:04 AM writes...

Hmmm... I wonder how much Pfizer paid Fortune mag for that little piece, casing doubt over the safety of generics?

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12. Kaleberg on May 6, 2011 11:16 PM writes...

Selling a generic version of one's own drug makes sense. It's like the fashion business where designers sell a full range of knock offs of their designs for the mid-market and even for the outlet store low end market. Why let someone else capture the sales?

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13. Nice on May 7, 2011 9:49 AM writes...

Hmmm... I wonder how much Pfizer paid Ranbaxy to have problems and delay the generic launch so that they could continue only selling branded lipitor. Every month adds another billion dollars or so.

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14. oldtimer on May 10, 2011 4:38 PM writes...

Don't forget Lipitor is not a Pfizer drug, they "liked it so much they bought the company"

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