Replies to post #26785 on Intellipharmaceutics International Inc. (IPCI)

[Biotech junkie]

Put me down for 6....

[WeeZuhl]

8 other

The Endo versions of generic Seroquel XR that received full approval and shipped on November 1 were from Par Pharmaceuticals, who purchased the ANDA from Handa. They were first to file on 50mg, 150mg, 200mg, and 300mg. These approvals are currently missing from the Orange Book. The other full approval went to Accord, and they were first to file for 400mg. They also shipped November 1, and this approval is currently still viewable in the Orange Book.


The problem for everyone else is that Handa (now Par/Endo) and Accord both have settled patent infringement suits with AstraZeneca. Both companies are shipping authorized generics. (Remember that term?). Everyone else is still blocked by a Seroquel XR patent, including Pediatric Exclusivity extension. The patent that is listed in the Orange Book for Seroquel XR will expire in May 2017 and has Pediatric Exclusivity extension until November 2017.





Orange Book:

https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022047&Appl_type=N

Patent and Exclusivity for: N022047

Product 001
QUETIAPINE FUMARATE (SEROQUEL XR) TABLET, EXTENDED RELEASE EQ 50MG BASE
Patent Data

Product------Patent No---------Patent Expiration
001------------5948437-----------May 28, 2017
001------------5948437*PED----Nov 28, 2017

http://www.pmlive.com/pharma_news/astrazeneca_sues_fda_seroquel_quetiapine_patent_generics_us_391157

AstraZeneca sues FDA over Seroquel patent exclusivity in US
14th March 2012
AstraZeneca granted both Handa and Accord a licence to enter the US market with their generic versions of Seroquel XR in November 2016.

http://www.prnewswire.com/news-releases/par-pharmaceutical-acquires-rights-to-market-and-distribute-generic-seroquel-xr-in-the-us-176239031.html

Par Pharmaceutical Acquires Rights to Market and Distribute Generic Seroquel XR® in the U.S.
Potential for 180-Day Marketing Exclusivity
29 Oct, 2012, 08:30 ET

Under the terms of a prior settlement agreement with AstraZeneca, which has been assigned to Par, Par has a license to enter the U.S. market with quetiapine fumarate extended-release tablets on November 1, 2016 or earlier under certain circumstances.