Navigation Links
Mylan Confirms First-to-File Patent Challenge Relating to Lescol(R)
Date:10/22/2008

PITTSBURGH, Oct. 22 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol(R) Capsules.

Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for the product. The company filed an ANDA with the U.S. Food and Drug Administration (FDA) in June. Novartis filed a lawsuit Oct. 10 in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent No. 5,354,772.

Fluvastatin Capsules, used in the treatment of high cholesterol, had approximately $60 million in sales for the twelve months ending June 30, 2008, according to IMS Health.

Currently, Mylan has 108 ANDAs pending FDA approval, 22 of which are potential first-to-file opportunities.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit http://www.mylan.com.

This press release includes statements that constitute "forward-looking statements," including with regard to the expected first to
'/>"/>

SOURCE Mylan Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Mylan Launches First Generic Version of Antihypertensive Sular(R) ER in the United States
2. Mylan Announces Final FDA Approval for Ropinirole Hydrochloride Tablets
3. Mylan Announces Amendment to Bystolic(TM) (Nebivolol) Agreement
4. Mylan Announces Final FDA Approval for Balsalazide Disodium Capsules
5. Mylan Announces Tentative FDA Approval for Lamotrigine Tablets
6. Mylan Announces Appointment of Steven G. Zylstra as Vice President of Global Corporate Communication and Public Relations
7. Mylan Inc. Subsidiary, Dey, L.P., Announces that Perforomist(TM) (Formoterol Fumarate) Inhalation Solution is Now Available for Maintenance Treatment of COPD
8. Mylan to Host Investor Day on October 3, 2007
9. Mylan Announces Pricing of Tender Offers for its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015
10. Chromos obtains interim order in connection with arrangement, announces annual and special meeting of shareholders and confirms mailing of information circular
11. Barr Confirms Patent Challenge of Sensipar(R) Tablets, 30mg, 60mg and 90mg
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Toronto, Canada (PRWEB) January 15, 2014 ... perspectives on nonclinical and clinical safety assessment in biosimilars. ... a path for biosimilar drug development, however the complex ... regards to quality, safety and efficacy extremely challenging. Based ...
(Date:1/15/2014)... DTS Language Services, Inc . is ... for Life Science organizations who need document translations. Clients ... of their documents in advance with a selection of nearly ... translations, often a critical factor in clinical and scientific fields, ...
(Date:1/14/2014)... Date: Friday, April 11, 2014 , Time: 6 ... Almshouse Road, Warrington, Pa. , Details: The Hepatitis ... finding a cure for hepatitis B and improving the quality ... Crystal Ball on Friday, April 11 at Warrington Country Club ...
(Date:1/14/2014)... EquitiesIQ, a leading informational research provider, ... is an emerging biomedical company acquiring, developing, manufacturing, and ... , Free report download: http://equitiesiq.com/reports/alliqua/ , In ... team and Board, which launched the company’s new strategy ...
Breaking Biology Technology:Xtalks Life Sciences Webinar Examines Safety Assessment of Biosimilars 2DTS Improves Efficiency for Life Science Document Translations 2Hepatitis B Foundation to Host Annual Crystal Ball Gala 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 3
... , , , , Multiporator / Electroporator 2510 , , , ... Transformation Protocol , Protocol No. 4308 915.538 04/2002 , ... , , , , ... , Cell type , Bacteria, gram ...
... , , , Multiporator / Electroporator 2510 , , , , , ... Transformation Protocol , , ... , , , , , , , , ... Azotobacter vinelandii, , , ...
... , , , Multiporator / Electroporator 2510 , , , , , ... Transformation Protocol , Protocol No. 4308 915.501 04/2002 , ... , , , ... , Cell type , Bacteria, gram negative, ...
Cached Biology Technology:Bifidobacterium animalis 2Azotobacter vinelandii 2Actinomyces viscosus 2
(Date:4/21/2014)... mountains across the western United States are dying, thanks to ... inner bark. , Some species of the beetles, such ... Others live in dead, weakened or dying hosts. , In ... of more than 3.4 million acres of pine trees. , ... flow and water quality? Plenty, according to new research findings ...
(Date:4/21/2014)... are on the decline in the Galpagos. , A new ... indicates numbers of the iconic birds, known for their ... attract mates, have fallen more than 50 percent in less ... is probably due to an unexplained disappearance of sardines from ... at Wake Forest University and the study,s principal investigator. This ...
(Date:4/21/2014)... from Pittsburgh University, find how lipid mediators are ... Chemistry. Lipid mediators are molecules playing an important ... some of them has earned a Nobel prize ... power plants", the organelles where oxidation of various ... a molecule universally used for storage and transportation ...
Breaking Biology News(10 mins):Earth Week: Bark beetles change Rocky Mountain stream flows, affect water quality 2Earth Week: Bark beetles change Rocky Mountain stream flows, affect water quality 3Lack of breeding threatens blue-footed boobies' survival 2Lack of breeding threatens blue-footed boobies' survival 3The anti-inflammatory factory 2The anti-inflammatory factory 3
... of the Neanderthal genome persists in modern human populations. ... 665 people from Europe and East Asia shows that more ... DNA of this contemporary group, whose genetic information is part ... that someone of non-African descent may have inherited approximately 1 ...
... thousand years ago, Homo sapiens migrating out ... diverged from modern humans hundreds of thousands of years ... Neanderthals mingled, and over time, produced children with genes ... collision between two distinct populations remain alive in the ...
... a single gene in honey bees separates the queens from ... University and Wayne State University unraveled the gene,s inner workings ... Biology Letters . The gene, which is responsible for leg ... of bees, ability to carry pollen. "This gene is ...
Cached Biology News:Neanderthal lineages excavated from modern human genomes 2Neanderthal lineages excavated from modern human genomes 3When populations collide 2When populations collide 3When populations collide 4Single gene separates queen from workers 2