Navigation Links
IntelliPharmaCeuitics Ltd. Announces Generic Drug Commercialization Activities
Date:10/22/2007

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:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room ... Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of ...
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA ... the Road To Recovery® program to drive cancer patients to and from their cancer ... ensure the highest quality of life and ongoing independence. Getting to and from ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Ill. , June 23, 2016  In a startling report ... are failing their residents by lacking a comprehensive, proven plan to ... a definitive ranking of how states are tackling the worst ... to only four states – Kentucky , ... Vermont . Of the 28 failing states, three ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... Forecast to 2022" report to their offering. ... date financial data derived from varied research sources to present ... impact on the market during the next five years, including ... sub markets, regional and country level analysis. The report provides ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
Breaking Medicine Technology: