Shire Comments on USPTO Petitions Related to Lialda and Gattex
![](/46/pdcnewsitem/03/43/52/mGaXPGP2p4MljyO.gif)
Shire acknowledges the two petitions filed with the US Patent and Trademark Office (USPTO) on 2 April by Hayman Capital Management regarding Lialda (mesalamine) and Gattex (teduglutide [rDNA origin]).
The patents listed in the FDA Orange Book for Lialda and Gattex protect the innovation and value Shire brings to patients who benefit from these important medicines. Shire will continue to defend vigorously its patents and pursue all legal options available to protect its products.
Lialda remains the only once-daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. Lialda is protected by the following FDA Orange Book listed patent: US Patent No. 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the “’720 patent”), which expires in 2020. This patent has already withstood a challenge on its validity in the Federal District Court for the Southern District of Florida. There have not been any approvals of generic versions of Lialda.
Gattex is approved in the US to treat adults with short bowel syndrome (SBS) who are dependent on parenteral support. Gattex was awarded Orphan Drug Designation by the FDA in 2012 and has orphan drug exclusivity until December 2019. Gattex is also protected by FDA Orange Book patents which expire in 2015, 2022 and 2025. The recently filed petition only challenges a subset of claims of the Gattex patent expiring in 2022. The remaining claims of that patent, and the claims of the other patents, were not challenged in the petition.
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance