Navigation Links
IntelliPharmaCeuitics Ltd. Announces Generic Drug Commercialization Activities

TORONTO, Oct. 22 /PRNewswire/ - IntelliPharmaCeutics Ltd. (the "Company") today announced the following with regard to its generic drug commercialization activities.

In late August of this year, we announced that the Company's operating affiliate IntelliPharmaCeutics Corp. ("IntelliPharmaCeutics") had received acceptance from the U.S. Food and Drug Administration for the filing of IntelliPharmaCeutics' generic drug application (known as an ANDA) for a drug product it has developed for commercialization with a drug development partner, using IntelliPharmaCeutics' proprietary controlled release drug delivery technology. The application seeks the FDA's approval to commercialize generic versions of each of 4 strengths of a branded drug called FOCALIN XR(R).

IntelliPharmaCeutics also filed the FDA's customary form of Paragraph IV certification which IntelliPharmaCeutics had delivered to the owners of certain patents listed with the FDA as pertaining to FOCALIN XR(R). This certification contains IntelliPharmaCeutics' indication that it believes that its generic versions of FOCALIN XR(R) do not infringe those patents and/or that the patents are invalid or unenforceable.

These generic drug products have been developed by IntelliPharmaCeutics under a collaboration arrangement with Par Pharmaceutical, Inc. ("Par" or "Par Pharmaceutical") which includes agreement that Par will be responsible for litigation and its costs. Par is the agent for IntelliPharmaCeutics in respect of its filing with the FDA for approval to commercialize the generic versions of FOCALIN XR(R).

Early in October, 2007, certain parties who have claimed to hold patents relating to FOCALIN XR(R) filed complaints alleging patent infringement. The complaints make such allegations against one or more of the Company, IntelliPharmaCeutics and Par. They comprise a complaint by Elan Corporation, PLC which alleges ownership of two pertinent U.S. patents and a complaint by Celgene Corporation, Norvartis Pharmaceutical and Novartis Pharma AG, which alleges ownership by Celgene of five pertinent U.S. patents. The latter complaint alleges that Novartis AG is the exclusive licensee and that Novartis Pharmaceutical is the manufacturer and distributor for FOCALIN XR(R) in the United States.

Lawsuits such as these are an ordinary and expected part of the process of obtaining approval to commercialize a generic drug product in the United States. The Company remains confident that IntelliPharmaCeutics' generic versions of FOCALIN XR(R) do not infringe those patents. Together with its development partner, Par Pharmaceutical, IntelliPharmaCeutics intends to vigorously defend against the complaints described above.

SOURCE IntelliPharmaCeutics Corp.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. PM announces a new health care order for India
2. Ramdoss Announces Introduction of RCH-II
3. Britain Announces Third Transfusion Related Mad Cow Case
4. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
5. Tibet Announces the Dalai Lama’s Tour of South Americ
6. NHS announces further Cost cutting Measures
7. Indian PM Announces Of Setting Up India Study Center At Tashkent
8. PowderMed Announces Needle-Less Flu Vaccine
9. Malaysia Announces Prison term On People Donating HIV-Contaminated Blood
10. Australian Government Announces Survey To Tackle Childhood Obesity
11. New Zealand Announces 10-year Plan For Betterment Of Mental Health Care
Post Your Comments:
(Date:11/27/2015)... ... 27, 2015 , ... The rapid speed at which Americans ... more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions becoming ... The forgotten part of this equation: 80 percent of medical care occurs in ...
(Date:11/27/2015)... ... November 27, 2015 , ... Lizzie’s Lice Pickers just announced a special ... 10% off of their purchase of lice treatment product. In addition, customers will receive ... a company spokesperson. “Finding lice is a sure way to ruin the holidays, so ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... motto of progress through sharing, the 2016 Building Better Radiology Marketing Programs ... conference will begin on Sunday, March 6, 2016, at Caesars Palace in Las ...
(Date:11/27/2015)... ... November 27, 2015 , ... Keeping ... platform for mental health and wellness consultation, has collaborated with a leading web-based ... the knowledge gap experienced by parents and bring advice from parenting experts within ...
(Date:11/27/2015)... San Francisco, California (PRWEB) , ... November 27, 2015 , ... ... 1969 Janis Joplin Ann Arbor Michigan boxing style concert posters. This is one of ... 1969 at the Canterbury House at the University of Michigan in Ann Arbor. The ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... Wound Care Market by Type (Dressings, Therapy Devices, Active ... Facility, Out-Patient Facility), and Geography - Global Forecast to ... --> --> The purpose of ... forecast of the global advanced wound care market. It ...
(Date:11/26/2015)... November 26, 2015 ... adds "Global Repaglinide Industry ... Report on China Repaglinide Market, 2010-2019" ... data and information to its online ... . --> ...
(Date:11/26/2015)... , Nov. 26, 2015 Research ... addition of the "2016 Future Horizons and ... (TDM) Market: Supplier Shares, Country Segment Forecasts, Competitive ... --> --> ... analysis of the Italian therapeutic drug monitoring market, ...
Breaking Medicine Technology: