Granted 180 Days of Generic Exclusivity for These Three Strengths
POMONA, N.Y., March 19 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc.
(NYSE: BRL) today announced that it has received approval from the U.S. Food &
Drug Administration for generic ADDERALL(R) (Dextroamphetamine Saccharate,
Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate)
Tablets, 7.5 mg, 12.5 mg, 15 mg. This mixed salts of a single-entity
amphetamine product is an AB rated generic equivalent of Shire US Inc.'s
ADDERALL tablets. The Company will launch these three product strengths
immediately.
The Company said that it has been granted 180 days of generic exclusivity,
commencing at launch, as a result of being the first to file an Abbreviated
New Drug Application (ANDA) containing a Paragraph IV certification for the
listed patent. The patent holder did not file suit against Barr within the
statutory forty-five day period.
In February 2002, Barr was the first to market and launch a generic
equivalent to Shire's ADDERALL Tablets, 5 mg, 10 mg, 20 mg and 30 mg.
"Our ability to gain the first generic approval and 180 day market
exclusivity for the additional strengths of generic ADDERALL expands our
current portfolio of dextroamphetaphine products, which includes generic
versions of GlaxoSmithKline's Dexedrine(R) Spansules(R) and Shire's
Dextrostat(R), as well as a filing for Shire's ADDERALL XR(TM) product, and
demonstrates our ability to accelerate the development of barrier-to-entry
products to ensure that we reach the marketplace before competitors," said
Bruce L. Downey, Barr's Chairman and CEO.
ADDERALL is indicated as an integral part of a total treatment program
which typically includes other remedial measures (psychological, educational,
social) for a stabilizing effect in children with behavioral syndrome
characterized by the following group of developmentally inappropriate
symptoms: moderate to severe distractibility, short attention span,
hyperactivity, emotional ability and impulsivity.
ADDERALL Tablets, 7.5 mg, 12.5 mg, and 15 mg have annual sales of
approximately $18 million for the twelve months ending January 2003.
Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in
the development, manufacture and marketing of generic and proprietary
pharmaceuticals.
Safe Harbor Statement: To the extent that any statements made in this
report contain information that is not historical, these statements are
essentially forward-looking. 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 like 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; market and customer acceptance and demand for our pharmaceutical
products; reimbursement policies of third party payors; our ability to market
our proprietary products; the successful integration of acquired businesses
and products into our operations; 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; availability of any product we purchase and sell as a
distributor; the regulatory environment; fluctuations in operating results,
including spending for research and development, sales and marketing and
patent challenge activities; and, other risks detailed from time-to-time in
our filings with the Securities and Exchange Commission, or SEC.
Forward-looking statements can be identified by the 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 statement. The Company undertakes no
obligation to publicly update any forward-looking statements.
SOURCE Barr Laboratories, Inc.
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Related links:
http://www.barrlabs.com
Company News On-Call:
http://www.prnewswire.com/comp/089750.html
CONTACT:
Carol A. Cox of Barr Laboratories, Inc.,
+1-845-348-6808, ccox@barrlabs.com
NOTES TO EDITORS: For complete indications, warnings and
contraindications, contact Barr Laboratories' Professional
Services Department at 1-800-Barr Lab. Adderall(R) and
Dextrostat(R) are registered trademarks of Shire US Inc. ADDERALL
XR(TM) is a trademark of Shire US Inc. Dexedrine(R) Spansules(R)
is a registered trademark of GlaxoSmithKline.
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