Barr Receives Tentative Approval for Modafinil Tablets, 100 mg and 200 mg

Jan 08, 2004, 00:00 ET from Barr Pharmaceuticals, Inc.

    WOODCLIFF LAKE, N.J., Jan. 8 /PRNewswire-FirstCall/ -- Barr
 Pharmaceuticals, Inc. (NYSE:   BRL) today announced that its wholly-owned
 subsidiary, Barr Laboratories, Inc., has received tentative approval from the
 U.S. Food and Drug Administration (FDA) for its generic version of Cephalon's
 Provigil(R) Tablets (Modafinil Tablets), 100 mg and 200 mg.  The Company is
 currently litigating whether its products infringe a patent held by Cephalon.
 A trial in the U.S. District Court of New Jersey is currently scheduled for
 January 2005.
     Barr's tentatively approved Modafinil Tablets is indicated to improve
 wakefulness in patients with excessive daytime sleepiness associated with
 narcolepsy.  Modafinil Tablets had annual sales of approximately $289 million,
 based on IMS data for the twelve months ended November 2003.
     Barr filed an Abbreviated New Drug Application (ANDA) for Modafinil
 Tablets, 100 mg and 200 mg, with the FDA on December 24, 2002, and received
 notification of the application's acceptance for filing in early February
 2003.  Following receipt of notice from FDA, Barr notified Cephalon on
 February 20, 2003 of Barr's challenge to the two patents that Cephalon had
 listed in the Orange Book in connection with Provigil(R).  On March 28, 2003,
 Cephalon filed suit against four generic pharmaceutical companies, including
 Barr, for alleged infringement of one of two listed Cephalon patents in U.S.
 District Court for the District of New Jersey.
     A tentative approval reflects FDA's preliminary determination that a
 generic product satisfies the substantive requirements for approval, subject
 to the expiration of all statutorily imposed non-approval periods.  A
 tentative approval does not allow the applicant to market the generic drug
 product.
     Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the
 development, manufacture and marketing of generic and proprietary
 pharmaceuticals.
 
     Forward-Looking Statements
     The following press release contains a number of forward-looking
 statements. To the extent that any statements made in this press release
 contain information that is not historical, these statements are essentially
 forward-looking. Forward-looking statements can be identified by their use of
 words such as "expects," "plans," "will," "may," "anticipates," "believes,"
 "should," "intends," "estimates" and other words of similar meaning. These
 statements are subject to risks and uncertainties that cannot be predicted or
 quantified and, consequently, actual results may differ materially from those
 expressed or implied by such forward-looking statements. Such risks and
 uncertainties include: 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 difficulty of predicting the
 timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA
 decisions on exclusivity periods; the ability of competitors to extend
 exclusivity periods for their products; the success of our product development
 activities; 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;
 the impact of competitive products and pricing; the ability to develop and
 launch new products on a timely basis; the availability of raw materials; the
 availability of any product we purchase and sell as a distributor; our mix of
 product sales between manufactured products, which typically have higher
 margins, and distributed products; the regulatory environment; 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 and products we acquire and implementing new enterprise
 resource planning systems; fluctuations in operating results, including the
 effects on such results from spending for research and development, sales and
 marketing activities and patent challenge activities; and other risks detailed
 from time to time in our filings with the Securities and Exchange Commission.
 
 

SOURCE Barr Pharmaceuticals, Inc.
    WOODCLIFF LAKE, N.J., Jan. 8 /PRNewswire-FirstCall/ -- Barr
 Pharmaceuticals, Inc. (NYSE:   BRL) today announced that its wholly-owned
 subsidiary, Barr Laboratories, Inc., has received tentative approval from the
 U.S. Food and Drug Administration (FDA) for its generic version of Cephalon's
 Provigil(R) Tablets (Modafinil Tablets), 100 mg and 200 mg.  The Company is
 currently litigating whether its products infringe a patent held by Cephalon.
 A trial in the U.S. District Court of New Jersey is currently scheduled for
 January 2005.
     Barr's tentatively approved Modafinil Tablets is indicated to improve
 wakefulness in patients with excessive daytime sleepiness associated with
 narcolepsy.  Modafinil Tablets had annual sales of approximately $289 million,
 based on IMS data for the twelve months ended November 2003.
     Barr filed an Abbreviated New Drug Application (ANDA) for Modafinil
 Tablets, 100 mg and 200 mg, with the FDA on December 24, 2002, and received
 notification of the application's acceptance for filing in early February
 2003.  Following receipt of notice from FDA, Barr notified Cephalon on
 February 20, 2003 of Barr's challenge to the two patents that Cephalon had
 listed in the Orange Book in connection with Provigil(R).  On March 28, 2003,
 Cephalon filed suit against four generic pharmaceutical companies, including
 Barr, for alleged infringement of one of two listed Cephalon patents in U.S.
 District Court for the District of New Jersey.
     A tentative approval reflects FDA's preliminary determination that a
 generic product satisfies the substantive requirements for approval, subject
 to the expiration of all statutorily imposed non-approval periods.  A
 tentative approval does not allow the applicant to market the generic drug
 product.
     Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the
 development, manufacture and marketing of generic and proprietary
 pharmaceuticals.
 
     Forward-Looking Statements
     The following press release contains a number of forward-looking
 statements. To the extent that any statements made in this press release
 contain information that is not historical, these statements are essentially
 forward-looking. Forward-looking statements can be identified by their use of
 words such as "expects," "plans," "will," "may," "anticipates," "believes,"
 "should," "intends," "estimates" and other words of similar meaning. These
 statements are subject to risks and uncertainties that cannot be predicted or
 quantified and, consequently, actual results may differ materially from those
 expressed or implied by such forward-looking statements. Such risks and
 uncertainties include: 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 difficulty of predicting the
 timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA
 decisions on exclusivity periods; the ability of competitors to extend
 exclusivity periods for their products; the success of our product development
 activities; 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;
 the impact of competitive products and pricing; the ability to develop and
 launch new products on a timely basis; the availability of raw materials; the
 availability of any product we purchase and sell as a distributor; our mix of
 product sales between manufactured products, which typically have higher
 margins, and distributed products; the regulatory environment; 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 and products we acquire and implementing new enterprise
 resource planning systems; fluctuations in operating results, including the
 effects on such results from spending for research and development, sales and
 marketing activities and patent challenge activities; and other risks detailed
 from time to time in our filings with the Securities and Exchange Commission.
 
 SOURCE  Barr Pharmaceuticals, Inc.

RELATED LINKS

http://www.barrlabs.com