Navigation Links
Mylan Confirms First-to-File Patent Challenge Relating to Vivelle-Dot®
Date:3/1/2011

PITTSBURGH, March 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day. This product is the generic version of Vivelle-Dot®, which is indicated for the treatment of symptoms associated with menopause, the treatment of hypoestrogenism and the prevention of postmenopausal osteoporosis.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for all strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for the Southern District of New York and the U.S. District Court for the District of Vermont.

Vivelle-Dot had U.S. sales of approximately $215 million for the 12 months ending Dec. 31, 2010, according to IMS Health. Currently, Mylan has 169 ANDAs pending FDA approval representing $97.9 billion in annual sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $24.8 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.

This press release includes statements that constitute "forward-looking statements," including with regard to the expected first-to-file status and pending litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially
'/>"/>

SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Mylan Receives Approval for Generic Version of Neurontin® Capsules
2. Mylan Launches First Generic Version of Vfend® Tablets
3. Mylan Receives Approval for First-to-File Generic Sular® Extended-Release Tablets
4. Mylans Matrix Obtains License for Promising HIV/AIDS Treatment
5. Mylan Announces Lipitor® Settlement Agreement
6. Mylan Announces Caduet® Settlement Agreement
7. Mylans Matrix Receives Approval for Generic Version of Protonix® Delayed-release Tablets
8. Mylans Matrix Receives Tentative FDA Approval Under PEPFAR for Lamivudine and Zidovudine Tablets, 30 mg/60 mg
9. Mylan Receives Approval for Generic Version of Precose® Tablets
10. Mylan Announces Voluntary De-listing of 1.25% Senior Convertible Notes Due 2012 from Nasdaq
11. Mylans Dey Pharma Partners with Meda to Market EpiPen® Auto-Injector in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... 28, 2014  TNI BioTech, Inc. (OTCQB: TNIB) ... on the development, marketing and distribution of opioid-related ... proxy materials with the Securities and Exchange Commission ... Shareholders to be held on Thursday, September 4, ... record date for determining those shareholders eligible to ...
(Date:7/28/2014)...  ResMed (NYSE: RMD ), an innovator ... sleep-disordered breathing and other chronic respiratory conditions, has won ... against Taiwanese medical device manufacturer APEX Medical Corp. (APEX), ... 210 and 220 masks.  The judgment was entered by ... , is appealable, and applies throughout Germany.  ...
(Date:7/28/2014)...  ANI Pharmaceuticals, Inc. (NASDAQ: ANIP ) ... second quarter and year-to-date 2014 financial results on Monday, ... financial markets. The earnings press release will be accessible ... www.anipharmaceuticals.com . Arthur S. Przybyl ... C. Arnold , Vice President and Chief Financial Officer, ...
Breaking Medicine Technology:TNI BioTech, Inc., Files Definitive Proxy Materials; Mails Letter Urging Shareholders to Vote the Proxy Card 2TNI BioTech, Inc., Files Definitive Proxy Materials; Mails Letter Urging Shareholders to Vote the Proxy Card 3ResMed Receives Permanent Injunction against APEX in Germany, Continues Enforcement of Patents in Europe 2ANI Pharmaceuticals Schedules Conference Call for Second Quarter 2014 Financial Results 2
... Fla., May 11, 2011 Radiation Therapy Services ... centers, today announced financial results for the first quarter ended ... quarter of 2011 were $156.5 million, an increase of 16.4% ... of 2010. The increase in revenue was principally due to ...
... May 11, 2011 Valor Medical announced today that ... for treating cerebral aneurysms. Neucrylate AN ... a microinfusion catheter into the aneurysm.  When Neucrylate AN ... it immediately changes from a liquid into a porous, ...
Cached Medicine Technology:Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 2Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 3Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 4Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 5Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 6Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 7Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 8Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 9Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 10Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 11
(Date:7/28/2014)... 2014 Quincy Bioscience, makers of the ... to announce the release of the fourth edition of ... co-founder Mark Underwood. , The Brain Health Guide is ... techniques for readers to improve memory and promote optimal ... The Brain Health Guide provides ways to help minimize ...
(Date:7/28/2014)... Randy Dotinga HealthDay ... Scientists know it takes humans just milliseconds to look at ... Now, a new study finds that certain facial features seem ... The shape and size of the mouth, for example, ... dimensions are keys to attractiveness. The study findings ...
(Date:7/28/2014)... 2014 Ticket Down is reliable ... in Dallas, TX at the Cotton Bowl. The 2014 ... USA and it is an eight team tourney. The ... including teams from La Liga, Serie A, English Premier League, ... it out on the pitch include: Manchester United, Manchester ...
(Date:7/28/2014)... Glutamine is the most abundant single amino ... conditionally essential during times when the body undergoes large ... Immune System Support. , Having a heavy work out ... with additional glutamine may be advantageous. Glutamine supplementation may ... digestion and immune system function. Stress on the body ...
(Date:7/28/2014)... HealthDay Reporter MONDAY, ... who are at risk of contracting meningitis because of ... according to updated recommendations from the largest pediatrician group ... for the potentially deadly infection should continue for adolescents ... In its first statement on meningococcal vaccines since ...
Breaking Medicine News(10 mins):Health News:Quincy Bioscience Launches the Fourth Edition of The Brain Health Guide 2Health News:Facial Dimensions May Be Key to First Impressions 2Health News:Facial Dimensions May Be Key to First Impressions 3Health News:Real Madrid vs. AS Roma Tickets Cotton Bowl Dallas, TX: Ticket Down Cuts Ticket Prices for AS Roma vs. Real Madrid International Champions Cup Tickets 2Health News:Real Madrid vs. AS Roma Tickets Cotton Bowl Dallas, TX: Ticket Down Cuts Ticket Prices for AS Roma vs. Real Madrid International Champions Cup Tickets 3Health News:Betancourt Nutrition Introduces Glutamine Plus with Sustamine® L-Alanyl-L-Glutamine 2Health News:Betancourt Nutrition Introduces Glutamine Plus with Sustamine® L-Alanyl-L-Glutamine 3Health News:Doctors Urge Meningitis Shots for Vulnerable Infants, Children 2Health News:Doctors Urge Meningitis Shots for Vulnerable Infants, Children 3
... Italians, conducted by Henley Management College and the University of ... the age of 65 is significantly higher than it ... this study was to make the first step in the ... of prescribing funds. ,The research found that the ...
... University researcher is experimenting with ways to add fibre to ... our favourite snacks . ,Sajid Alavi is an ... of Agriculture. ,His expertise is in extrusion ... to pet food. ,Alavi is researching how ...
... found a strong relationship between negative mood and multiple ... London Health Sciences Centre , London, Canada, said that ... importance of couples emotional health during IVF treatment, and ... ,A reduction in the incidence of multiple pregnancies with ...
... delivery company, announced positive results from its Phase ... each containing a progestin and an estrogen . ... study, investigating the delivery of a formulation combining Nestorone ... of the combination formulation was applied to the forearm ...
... Now all those doting dads will be given some tips ... e-mails . ,The British government is hoping that ... to support parents will appeal to fathers, as it makes ... electronic organisers and instant messaging. ,Under the ...
... A tongue-tying device that effectively pulls the tongue closer to ... treating problems of snoring and sleep apnea, suggest early results ... of respiratory organs and the resulting sound due to obstructed ... soft or loud and unpleasant. It can sometimes be frustrating ...
Cached Medicine News:Health News:Now, Fibre-enriched Tasty Snacks in the Making 2Health News:Womens Mood Plays a Key Role in Infertility Treatment 2Health News:Contraceptive Spray Shows Positive Clinical Trial Result 2Health News:New Device to Treat Snoring and Sleep Apnea 2
Threaded cannula for use with Suretac® II, sterile packs, box of 10....
... Blitz Suture Retriever is for arthroscopic and open ... design eliminates complicated procedural steps. It may ... suture material and in conjunction with,anchors or screws ... small, curved needle tip permits the placement of ...
Suture retriever forceps...
Knot pusher/suture retriever...
Medicine Products: