One down, six to go as AstraZeneca hands off Handa ANDA on Seroquel XR
This article was originally published in Scrip
As part of a settlement agreement for one of its ongoing patent infringement litigation cases concerning Seroquel XR (quetiapine fumarate) extended-release tablets, AstraZeneca has granted Handa Pharmaceuticals a licence to enter the US market with a generic version of the drug, on 1 November 2016 or earlier upon certain circumstances.
However, six other challenges to the AstraZeneca patent estate on Seroquel XR remain, the company told Scrip, "Seven generics companies have filed ANDAs and are challenging patents protecting Seroquel XR. Those entities are Handa, Accord, Anchen, Torrent, Osmotica, Mylan and Intellipharmaceutics."
The company added: "The remaining Seroquel XR patent infringement litigations (all of the above less Handa) remain on-going. The trial will be begin on 3 October 2011 and held in the US District Court for the District of New Jersey. The recently filed Intellipharmaceutics case has not been consolidated with the others."
Seroquel XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017.
As part of this first agreement, Handa has consented not to further dispute that both patents asserted by AstraZeneca in the US patent litigation are valid and enforceable.
AstraZeneca told Scrip: "Handa [had] challenged the patent which protects Seroquel XR's formulation. The terms of AstraZeneca's US Seroquel XR settlement with Handa are consistent with AstraZeneca's previous US patent settlements. This is a settlement between Handa and AstraZeneca (not a legal hearing) and the terms of the settlement remains confidential."
On 13 December, 2010 Handa announced that it had received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) seeking approval for generic copies of Seroquel XR. The company also said it believed it was the first applicant to file for 50, 150, 200 and 300mg tablets and, so would be entitled to 180 days of marketing exclusivity for these tablet strengths upon receipt of final regulatory approval.
Following this announcement, AstraZeneca filed the patent infringement litigation. Now, AstraZeneca has said it had entered into a settlement agreement in the patent infringement case against Handa Pharmaceuticals, regarding Handa’s proposed generic version of the drug.
"AstraZeneca and Handa will file a proposed Consent Judgment with the US District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Handa. The remaining Seroquel XR patent infringement litigations remain on-going," AstraZeneca said.
The company added, "This settlement will have no impact on the company’s full year 2011 financial guidance (which is expected with the Q3 2011 financial results on 27 October).
AstraZeneca stressed that the latest settlement will not affect availability of generic versions of Seroquel IR, which is not interchangeable with Seroquel XR and that the two are approved for different indications.