FDA Approves first Generic Crestor
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The FDA approved the first generic version of Crestor.
Good news for patients! AZ has over charged for Crestor since day one! I hope sales drop to $0 overnight!
Not really. There are 10 ANDA's approved for rosuvastatin: (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm and search for rosuvastatin).
Maybe what you mean is that there are news stories that say that Actavis will begin selling generic rosuva starting on May 2nd?:
"AstraZeneca has agreed in the settlement of a lawsuit against Actavis Inc., involved in the generic market. The agreement will allow Actavis to have the rights to sell the Crestor generic from May 2, 2016. The company is bound to pay an amount equal to 39% of the net sales until the pediatric patent expires in July 2016."
http://www.businessfinancenews.com/28405-will-astrazeneca-survive-after-drugs-patent-expiration/
The other competitor generics won't appear for 67 days after 2nd of May.
Maybe what you mean is that there are news stories that say that Actavis will begin selling generic rosuva starting on May 2nd?:
"AstraZeneca has agreed in the settlement of a lawsuit against Actavis Inc., involved in the generic market. The agreement will allow Actavis to have the rights to sell the Crestor generic from May 2, 2016. The company is bound to pay an amount equal to 39% of the net sales until the pediatric patent expires in July 2016."
http://www.businessfinancenews.com/28405-will-astrazeneca-survive-after-drugs-patent-expiration/
The other competitor generics won't appear for 67 days after 2nd of May.
Where are all of the deniers now? Making phone calls to anyone they think might be able to save their sorry ass. Where is Mr. All Day Lie guy now? Shitting his pants is where.
The first generic to get their ANDA approved by the FDA gets 6 months of exclusivity against the other generics. Typically the first one only undercuts the price by 20% or so during this period. When the generic exclusivity period expires, 6 months after the pediatric exception expires (not a new patent, you just need to do a pediatric clinical trial good or bad) which will be in December, then the bottom completely falls out on the drug the price and the innovator typically then loses over 90% of their business. That is when the Crestor reps will likely all be axed. They won't want to leave even a dime on the table.
Financial Analysts predict that Crestor will lose 5 to 6 billion in sales by 2018. Now how exactly do we replace that source of revenue? Only one solution is to cuts costs and all that is left is the sales force. Our largest cost item.
AZ's results for 2015 reported a net profit of 2.8billion after tax, and revenue for Crestor of 5billion…...
That was before the patent expired. Pfizer had 11 billion a year in sales of Lipitor. How much Lipitor does Pfizer sell now? Not very much.
That's exactly my point. When the Crestor patent protection ends at the end of July the loss of revenue will more than wipe out AZ's total net profit and AZ will likely be running an annual loss of about $2bn if nothing changes.
With the Pediatric extension extending exclusivity for AZ and the first approved ANDA single company generic 6 month exclusivity added on, with which AZ has already cut a deal. Most Crestor Reps may make it to the year end. 2017 will be when the huge cuts come for this group. The Crestor business will all very rapidly disappear for AZ once all of the generic ANDA approved generic companies hit the market too. Be prepared.
The communication stated that by July at least 3 companies making the generic.
Yep, Phase I cut 1.1 billion in costs Phase II when the full impact of Crestor lost sales is realized, cut and additional $2-$3 billion. It is not going to get better anytime soon.
It is not going to be pretty at all. Crestor has recently been supplying a large percentage of AZ's profitability. Like all of the historical losses of huge blockbusters by big pharma, very painful change invariably follows. The loss of Nexium a little while back is just another example.
You just can't replace a profitable product like Crestor very quickly. Even if you launched something great today, it would take several years to reach that level of sales and profitability. There will be at least a couple of very painful years ahead for the AZ survivors. The rest of us won't have to worry about that, because we will have moved on to somewhere else by then. Even if the big oncology bet works, it will take a few years to pay off.
Just a legal tactic; they won't win. It's SOP these days.