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Adderall XR generic

This is a discussion on Adderall XR generic within the Managed Care Issues for Oral Drugs forum, part of the Managed Care Drug Coverage category; According to Shire, generic competition for its authorized generic will not be available in the near future. Any updates on ...


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Old 12-09-2009, 05:21 PM
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Default Adderall XR generic

According to Shire, generic competition for its authorized generic will not be available in the near future. Any updates on MAS ER generics? Thanks
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Old 12-10-2009, 03:41 PM
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Default Re: Adderall XR generic

There are 2 authorized generics by Teva and Impax that are currently available. Shire just settled with Sandoz on what appears to be the first ANDA-based generic. Per the terms of agreement, as soon as the FDA grants final approval Sandoz can launch their generic. The FDA has not yet issued any tentative approvals, but Sandoz's application was submitted in 4Q06. The Citizen Petition has not been resolved yet and it's unclear how long it might take. Apparently this delay is what is holding up the Sandoz ANDA. Although Shire filed litigation with other companies, according to it's latest release, this is the last litigation involving Adderall XR.
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