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:4/23/2017)... ... April 23, 2017 , ... Altura Communication Solutions, ... of Cisco Select certification and SMB specialization. Altura is now qualified to ... In earning the Select Certification, Altura fulfilled the training and exam requirements for ...
(Date:4/22/2017)... ... April 22, 2017 , ... ... PROSHRED® Security of Philadelphia its “Woman-Owned Small Business of the Year, ... providing information destruction , recycling, and compliance services to businesses throughout ...
(Date:4/22/2017)... Freedom, PA (PRWEB) , ... April 22, 2017 ... ... healthcare experience to his role as Vice President of Sales and Business Development ... of key GPO/IDN business partner engagements, business development, and strategic planning for the ...
(Date:4/21/2017)... , ... April 21, 2017 , ... An April 10 ... a pair of ancient teeth, which reveal a great deal about prehistoric ice-age dental ... sharp stone may have been used to remove decayed dental matter, and that teeth ...
(Date:4/21/2017)... ... April 21, 2017 , ... The staff at Palm Beach Face is proud to announce ... the 2017 London Marathon. Set to take place on April 23rd, the London Marathon has ... Schwartz will run as part of team EMPOWER, raising money for the international charity, Smile ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... , April 19, 2017 The Mobile X-Ray product ... a healthy CAGR during the forecast period Mobile ... the global digital mobile X-Ray devices market, which is estimated ... 2017, expanding at a CAGR of 7% over the forecast ... opportunity of more than US$ 100 Mn in 2017 over ...
(Date:4/19/2017)... April 19, 2017 Global Prostate Cancer ... on the prostate cancer therapeutics market analyzes the ... Increasing prevalence of prostate cancer, launch of promising ... development of new drugs & therapeutic biological products, ... due to lesser side effects are some of ...
(Date:4/19/2017)... , April 19, 2017  Sorrento Therapeutics, ... antibody-centric, clinical-stage biopharmaceutical company developing new treatments for ... the closing of its previously announced underwritten public ... at a public offering price of $2.00 per ... estimated offering expenses payable by Sorrento.  The net ...
Breaking Medicine Technology: