Navigation Links
Perrigo Confirms First to File Patent Challenge for Generic Version of Testosterone Gel 1.62%
Date:2/19/2013

ALLEGAN, Mich., Feb. 19, 2013 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO; TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application for testosterone gel 1.62% and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.

(Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO )

On February 15, 2013, the Unimed Pharmaceuticals subsidiary of AbbVie and Besins Healthcare filed suit against Perrigo in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.

Androgel® 1.62% (testosterone gel 1.62%) is indicated to treat males who have low or no testosterone. Annual sales were approximately $680 million annually, as measured by Wolters Kluwer Health.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and continued focus on bringing extended topicals to market. As always, Perrigo is committed to making quality healthcare more affordable for our customers and consumers."

Previously, on November 2, 2011, Perrigo announced that it filed with the FDA a New Drug Application for testosterone gel 1.0% and that it notified Abbott Products Inc., the owner of the Reference Listed Drug of its filing (http://perrigo.investorroom.com/2011-11-02-Perrigo-Confirms-Filing-for-Testosterone-Gel-1.0-and-Announcement-of-Patent-Infringement-Lawsuit-by-Abbott).          

From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, pet health, dietary supplements and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).

Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections.  While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 30, 2012, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Perrigo Company
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Perrigo Company To Present At The Leerink Swann Global Healthcare Conference
2. Perrigo Company Acquires U.K.-based Rosemont Pharmaceuticals Ltd. For Approximately £180 Million Or $283 Million
3. Perrigo Confirms FDA Approval For Testosterone Gel 1%
4. Perrigo Reports Record Second Quarter Revenue, Adjusted Earnings and Operating Cash Flow
5. Perrigo Company To Acquire OTC Companion Animal Health Company, Velcera, Inc., For $160 Million
6. Perrigo Commences Launch Of Clobetasol Emulsion Propionate Foam, 0.05%
7. Perrigo Company To Release Second Quarter Fiscal Year 2013 Results On February 1, 2013
8. Perrigo Company Announces The Appointment Of Industry Veteran To Executive Vice President And General Manager, Rx
9. Perrigo Announces FDA Final Approval Of Betamethasone Valerate Foam 0.12%
10. Perrigo Company To Present At The Credit Suisse Healthcare Conference
11. Perrigo Reports Record First Quarter Revenue And Adjusted Earnings And Raises Full Year Adjusted EPS Guidance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... , April 27, 2016 Transparency ... "Skincare Devices Market - Global Industry Analysis, Size, Share, ... the report, the global skincare devices market was valued ... to expand at a CAGR of 10.1% from 2015 ... Browse the full Skincare Devices Market (Treatment Device ...
(Date:4/27/2016)... Kan. , April 27, 2016  Bayer ... , a senior from the University of Florida ... of the Bayer Excellence in Communication Award (BECA). ... schools, which were awarded a total of $70,000 ... the last four years, Bayer has provided a ...
(Date:4/27/2016)... April 27, 2016 Oasmia ... developer of a new generation of drugs within ... survival results for Paclical/Apealea in the Phase III ... with epithelial ovarian cancer. These preliminary results showed ... combination with carboplatin versus Taxol in combination with ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... April 28, 2016 , ... In 2011, TIME magazine named Herr ... field of biomechatronics, technology that marries human physiology with electromechanics. He continues that work ... also the Founder of BionX , a leader in the field of prosthetic ...
(Date:4/28/2016)... ... April 28, 2016 , ... One way to ignore solid evidence is ... true. But we toss the baby out with the bathwater when we ignore all ... identifying higher-quality studies and otherwise making better use of education policy research. , “When ...
(Date:4/28/2016)... ... April 28, 2016 , ... Anzu®, ... announced a new Residency Education & Collaboration Platform for hospitals and medical ... and a host of collaboration tools designed to improve patient outcomes through ...
(Date:4/28/2016)... ... April 28, 2016 , ... Accreditation Commission for Health Care ... (COPA) to develop a comprehensive Specialty Pharmacy Accreditation with Distinction in Oncology. This ... ACHC provides a wide range of pharmacy accreditation services that assess the business ...
(Date:4/28/2016)... MO (PRWEB) , ... April 28, 2016 , ... Denise McCormick Baich had written poetry ... 2009 the poetry arrived again much like a tsunami and took on a more spiritual ... to her encouraged her to do more with it than just file it away. Friends ...
Breaking Medicine News(10 mins):