Navigation Links
Barr Confirms Patent Challenge of Entocort(R), 3mg Enteric Coated Capsules
Date:5/27/2008

MONTVALE, N.J., May 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by AstraZeneca LP in connection with its Entocort(R) Enteric Coated Capsules (budesonide), 3mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Entocort EC.

Barr filed its ANDA containing a paragraph IV certification for a generic Entocort EC product with the U.S. Food & Drug Administration (FDA) in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.

On May 22, 2008, AstraZeneca filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Entocort EC (budesonide) had annual sales of approximately $125 million in the U.S., based on IMS sales data for the twelve-month period ending March 2008.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 27 proprietary products in the U.S. and approximately 1,025 products globally outside of the U.S. For more information, visit http://www.barrlabs.com.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non-infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements and our forecasts; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment in the markets where we operate; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies (such as PLIVA d.d.) and products we acquire and implementing our new SAP enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; our expansion into international markets through our PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our significantly increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and other risks detailed in our SEC filings, including in our Annual Report on Form 10-K for the year ended December 31, 2007.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.


'/>"/>
SOURCE Barr Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Kiwa Bio-Tech Confirms Joint Venture Agreement With Shijiazhuang Huaxing Animal Medicine Co., Ltd.
2. Two Year Study Confirms SUPPRELIN(R) LA Implant Maintains Profound Suppression of Hormones in Children With Premature Onset Puberty
3. Study Confirms Anti-Infective ARIKACE(TM) Effectively Penetrates Mucus and Biofilm, and Kills Pseudomonas, a Bacteria Plaguing Cystic Fibrosis Patients
4. U.S. Patent Office Confirms Validity of Osteotechs U.S. Patent No. 5,676,146
5. Research Confirms Better Oil from New DuPont High Oleic Soybean Trait
6. Publication in Clinical Cancer Research Confirms Ability of Peregrines Bavituximab to Target Tumor Blood Vessels with Excellent Specificity
7. PPD Confirms Takedas NDA Filing of Alogliptin with U.S. Food and Drug Administration
8. Barr Confirms Patent Challenge of Avodart(R) Soft Gelatin Capsules, 0.5mg
9. Icahn Confirms Intention to Nominate Three Directors at Biogen
10. Barr Confirms Patent Challenge of Namenda(R) Tablets, 5mg & 10mg
11. Barr Confirms Patent Challenge of Eloxatin(R) Injectable, 5mg/mL
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... ClinCapture, ... Pennsylvania Convention Center and will showcase its product’s latest features from June 26 ... presenting a scientific poster on Disrupting Clinical Trials in The Cloud during the ...
(Date:6/23/2016)... ... June 23, 2016 , ... Velocity Products, ... tools designed, tuned and optimized exclusively for Okuma CNC machining centers at The ... of a collaboration among several companies with expertise in toolholding, cutting tools, machining ...
(Date:6/23/2016)... 23, 2016 ReportsnReports.com adds ... to its pharmaceuticals section with historic and forecast ... much more. Complete report on the ... profiling 15 companies and supported with 261 tables ... . The Global Cell Culture ...
(Date:6/22/2016)... Research and Markets has announced the addition of the ... The global biomarkers market ... 2013. The market is expected to grow at a five-year compound ... from $50.6 billion in 2015 to $96.6 billion in 2020. ... (2015 to 2020) are discussed. As well, new products approved in ...
Breaking Biology Technology:
(Date:6/22/2016)... , June 22, 2016   ... management and verification solutions, has partnered with ... software solutions for Visitor Management, Self-Service Kiosks ... provides products that add functional enhancements to ... provides corporations and venues with an automated ...
(Date:6/21/2016)... June 21, 2016 NuData Security announced today ... role of principal product architect and that ... of customer development. Both will report directly to ... The moves reflect NuData,s strategic growth in its ... high customer demand and customer focus values. ...
(Date:6/16/2016)... SAN FRANCISCO , June 16, 2016 /PRNewswire/ ... Market size is expected to reach USD ... report by Grand View Research, Inc. Technological proliferation ... and banking applications are expected to drive the ... ) , The development of ...
Breaking Biology News(10 mins):