Navigation Links
Barr Confirms Patent Challenge of Sensipar(R) Tablets, 30mg, 60mg and 90mg

MONTVALE, N.J., July 29 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Amgen Inc. in connection with its Sensipar(R) Tablets (cincalcet hydrochloride), 30mg, 60mg and 90mg.

Barr's Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Sensipar product was received as acceptable for filing by the U.S. Food & Drug Administration (FDA) on March 10, 2008, the first date the FDA could accept an ANDA with a paragraph IV certification for this product. 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 July 25, 2008, Brigham and Women's Hospital Inc., NPS Pharmaceuticals, Inc. and Amgen 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.

Sensipar (cincalcet hydrochloride) had annual sales of approximately $377 million in the U.S., based on IMS sales data for the twelve month period ending May 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

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. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
2. Study Published in Clinical Cancer Research Confirms Potential Of Peregrines Bavituximab Combined With Radiation In Lung Cancer
3. Recent Study Confirms Alimentary Healths Bifantis(R) Demonstrates Efficacy in the Treatment of Irritable Bowel Syndrome
4. Barr Confirms Patent Challenge of Focalin(R) XR
5. Barr Confirms Patent Challenge of Eloxatin(R) Injectable, 5mg/mL
6. Barr Confirms Patent Challenge of Namenda(R) Tablets, 5mg & 10mg
7. Icahn Confirms Intention to Nominate Three Directors at Biogen
8. Barr Confirms Patent Challenge of Avodart(R) Soft Gelatin Capsules, 0.5mg
9. PPD Confirms Takedas NDA Filing of Alogliptin with U.S. Food and Drug Administration
10. Publication in Clinical Cancer Research Confirms Ability of Peregrines Bavituximab to Target Tumor Blood Vessels with Excellent Specificity
11. Research Confirms Better Oil from New DuPont High Oleic Soybean Trait
Post Your Comments:
(Date:6/23/2016)... , June 23, 2016 /PRNewswire/ - FACIT ... Ontario biotechnology company, Propellon Therapeutics ... development and commercialization of a portfolio of first-in-class ... Epigenetic targets such as WDR5 represent an exciting ... significantly in precision medicine for cancer patients. Substantial ...
(Date:6/23/2016)... 2016  The Prostate Cancer Foundation (PCF) is pleased to announce ... cures for prostate cancer. Members of the Class of 2016 were selected from ... Read More About the Class of 2016 PCF Young Investigators ... ... ...
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the sample tracking ... Arkansas State Crime Laboratory, has joined STACS DNA as a Field Application Specialist. ... Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding our capacity as ...
(Date:6/23/2016)... , June 23, 2016 ... Review, 2016;12(1):22-8 Published ... the peer-reviewed journal from touchONCOLOGY, Andrew D ... cost of cancer care is placing an increasing ... of expensive biologic therapies. With the patents on ...
Breaking Biology Technology:
(Date:5/16/2016)... , May 16, 2016   EyeLock LLC , ... announced the opening of an IoT Center of Excellence ... and expand the development of embedded iris biometric applications. ... level of convenience and security with unmatched biometric accuracy, ... identity aside from DNA. EyeLock,s platform uses video technology ...
(Date:4/28/2016)... 28, 2016 First quarter 2016:   ... compared with the first quarter of 2015 The gross ... M (loss: 18.8) and the operating margin was 40% (-13) ... Cash flow from operations was SEK 249.9 M (21.2) , ... is unchanged, SEK 7,000-8,500 M. The operating margin for ...
(Date:4/15/2016)... Research and Markets has announced ... 2016-2020,"  report to their offering.  , ... global gait biometrics market is expected to grow ... 2016-2020. Gait analysis generates multiple variables ... to compute factors that are not or cannot ...
Breaking Biology News(10 mins):