Mylan Comments regarding Copaxone:
FDA's implementation of GDUFA has provided more challenges and opportunities for us. We did not receive a number of key approvals that we had anticipated, most notably, Copaxone and Lidoderm. However, on the flip side, we have seen our competitors experience the same and have seen opportunities as a result. Further, GDUFA also has resulted in supply chain disruptions at certain of our competitors, and Mylan has always been well positioned to maximize the opportunities that have presented themselves. This has underscored the importance of having an integrated quality global supply chain as well as the value of our commitment to one global quality center across our network.
We also have seen additional opportunities arise as the result of global consolidation among our customers. As to Copaxone, we continue to be engaged with the FDA on our application. As we told you last quarter, we have responded to all FDA requests to date in terms of our ANDA, and we remain confident that we are well positioned to receive approval for our application. On the Copaxone litigation front, we appreciated the opportunity to present our arguments to the U.S. Supreme Court a few weeks ago and remain confident in our position. We look forward to receiving the course this year.
We also announced that our ANDA for a generic version of 3-times-per-week Copaxone 40-milligram per ml has been accepted for filing by FDA. We believe we are one of the first companies to have filed a substantially complete ANDA containing a paragraph for certification, and we expect to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.
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Q&A
Gregory B. Gilbert - Deutsche Bank AG, Research Division
Do you still believe the generic Copaxone could be approved at any time? You've been saying for some time that you've resolved all issues or questions. So I want to make sure that you believe an approval could happen at any time and wondering why you link that to GDUFA slowdowns. I'm not sure if you are linking those 2 things or not.
Rajiv Malik - President, Director and Member of Science & Technology Committee
And Greg, as far as Copaxone is concerned, as I said in my prepared remarks, that we do not have any scientific issue -- outstanding scientific issue to date. We have responded -- the last set of questions were responded maybe 6, 8 months back. And we have been working and staying very close to the FDA and we have been guiding The Street accordingly, but we have been hearing from FDA. Obviously, the transformation at FDA, their rolling out of GDUFA and all, we have seen overall impact, a huge impact, and that is a slowdown. So we don't see any outstanding issue at this time where we stand. That's why we imply that, yes, we can see approval any time. But again, being prudent, we have taken it out of this year's guidance.
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Sounds no different than Wheeler's slip-into next year comment.
