Navigation Links
District Court Upholds FDA's Grant of 5-Year Market Exclusivity to VYVANSE(R)
Date:3/4/2010

PHILADELPHIA, March 4, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the United States District Court for the District of Columbia ("Court"), following extensive briefing by the parties and an oral hearing, has upheld the decision of the U.S. Food and Drug Administration ("FDA") to grant 5-year New Chemical Entity ("NCE") exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R).

On February 23, 2007, after reviewing the requisite clinical studies submitted on behalf of VYVANSE, the FDA determined that VYVANSE qualified as an NCE within the meaning of the governing statutes and regulations. As an NCE, VYVANSE is entitled to 5-year market exclusivity. The FDA therefore appropriately refused to file the Abbreviated New Drug Application ("ANDA") submitted by Actavis Elizabeth, LLC for generic lisdexamfetamine dimesylate. On February 24, 2009, Actavis sued the FDA in the District Court of the District of Columbia challenging the NCE decision. On April 13, 2009, the FDA opened a public docket to consider Actavis's challenge to the FDA's regulations governing NCE exclusivity and the corresponding award of exclusivity to VYVANSE. On October 23, 2009, following a thorough administrative review, the agency affirmed lisdexamfetamine, the active ingredient in VYVANSE, is a new active moiety and that its prior designation of VYVANSE as an NCE was proper.

Shire is pleased that on March 4, 2010, following the extensive briefing of the parties and an oral hearing, the Court upheld the FDA's decision (and reaffirmation) that VYVANSE is entitled to 5-year market exclusivity. The Court correctly determined that FDA's actions complied with federal administrative law standards as a reasonable exercise of the agency's scientific expertise. The five-year exclusivity period for VYVANSE expires on February 23, 2012, and precludes generic manufacturers from submitting an ANDA to FDA until that time, or until February 23, 2011 should a generic applicant challenge the United States patents covering Vyvanse, which remain in effect until June 29, 2023.

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

SOURCE Shire plc

Back to top
'/>"/>
SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. US District Court Enters Final Judgment in Favor of Smith & Nephew; Permanent Injunction Prohibits Arthrex Inc. From Selling Infringing Medical Devices
2. District Court Sides with Smith & Nephew; Rules that It will Issue Injunction that will Prohibit Arthrex Inc. from Selling Infringing Medical Devices
3. District Judge Dismisses Shareholder Suit Related to Boston Scientific
4. Ventria Receives Friends of Education Award From Geary County School District
5. U.S. District Court Decision About Eisais Legal Action Over Aricept ODT(R) ANDA Filing
6. YM BIOSCIENCES OFFER FOR CYTOPIA APPROVED TO PROCEED TO SHAREHOLDER VOTE BY AUSTRALIAN COURT
7. deCODE genetics, Inc. Announces Approval of First Day Motions by Bankruptcy Court
8. Ironwood Appoints Thomas McCourt As Chief Commercial Officer and Senior Vice President of Marketing and Sales
9. Isolagen, Inc. Announces Receipt of Interim Order from Bankruptcy Court Approving DIP Motion
10. Hospira Receives Favorable Court Decision on Eloxatin(R)
11. The Court Supports Bavarian Nordics Decision to Start Patent Infringement Case Against Oxford BioMedica
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... February 23, 2017 , ... David ... Inventors Recognition Reception at Purdue Research Park of West Lafayette, Indiana. ... recognition of outstanding contributions to, and success with, commercializing discoveries from Purdue research. ...
(Date:2/23/2017)... , Feb. 23, 2017  Capricor Therapeutics, Inc. (NASDAQ: CAPR), ... medical conditions, today announced that Linda Marbán, Ph.D, president and ... investor conferences: Cowen and Company 37th ... am ET Boston, MA ... 9:00 am PT (12:00 pm ET) Dana Point, ...
(Date:2/23/2017)... BELLINGHAM, Washington, USA, and CARDIFF, UK (PRWEB) , ... ... ... SPIE, the international society for optics and photonics , have been named Fellows ... each individual’s significant scientific and technical contributions in the multidisciplinary fields of optics, ...
(Date:2/22/2017)... (PRWEB) , ... February 22, 2017 , ... Park ... free AFM Luncheon for all SPIE attendees and Park customers ... just one block from the San Jose Convention Center. The luncheon will feature ...
Breaking Biology Technology:
(Date:2/6/2017)... According to Acuity Market Intelligence, ongoing ... to continue to embrace biometric and digital identification ... Border Control (ABC) eGates and 1436 Automated Passport ... 163 ports of entry across the globe. Deployments ... combined CAGR of 37%. APC Kiosks reached 75% ...
(Date:2/2/2017)... Feb. 2, 2017  EyeLock LLC, a market leader ... white paper " What You Should Know About Biometrics ... ensuring user authenticity is a growing concern. In traditional ... users. However, traditional authentication schemes such as username/password suffer ... Biometric authentication offers an elegant solution to the problem ...
(Date:1/30/2017)... SAN FRANCISCO , Jan. 30, 2017   ... of the fastest growing genetic information companies, today announced ... 2016 financial results and provide 2017 guidance on Monday, ... a conference call that day at 4:45 p.m. Eastern ... call, Invitae,s management team will briefly review financial results, ...
Breaking Biology News(10 mins):