Mallinckrodt Launches Generic Version of CONCERTA® in U.S.

  Mallinckrodt Launches Generic Version of CONCERTA® in U.S.

   Company to hold six-month exclusivity on 27, 36 and 54 milligram dosage
                         strengths of ADHD treatment

Business Wire

ST. LOUIS -- December 31, 2012

Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today
announced that it has received approval from the U.S. Food and Drug
Administration (FDA) to manufacture and market a generic version of CONCERTA^®
(methylphenidate HCl) Extended-Release (ER) Tablets USP (CII) in 27, 36 and 54
mg dosage strengths. The company will launch Methylphenidate HCl ER Tablets in
the 27 mg dosage strength immediately.

Methylphenidate HCl ER Tablets are indicated for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older,
adolescents and adults up to the age of 65 as an integral part of a total
treatment program for ADHD that may include other measures (psychological,
educational, social). Mallinckrodt believes it holds a separate 180-day
exclusivity period for each of the 27, 36 and 54 mg dosage strengths, which
begins upon commercial launch of each respective dosage strength.
Mallinckrodt’s current plan is to have the 36 mg and 54 mg dosage strengths
commercially available in the first calendar quarter of 2013. Mallinckrodt
plans to submit a supplement to its approved abbreviated new drug application
for the 18 mg dosage strength in the first calendar quarter of 2013.

“This approval represents an important addition to our line of generic
pharmaceutical products, and we look forward to providing an affordable
treatment option to patients coping with ADHD,” said Mark Trudeau, President,
Mallinckrodt. “We are pleased the FDA found that our long-acting technology
delivers a dose which is therapeutically equivalent to what is currently on
the market."

Mallinckrodt is the largest U.S. supplier of opioid pain medications and among
the top 10 generic pharmaceuticals manufacturers in the U.S., based on
prescriptions. Covidien announced in December 2011 that it plans to spin off
Mallinckrodt into a stand-alone company, a process expected to be completed in

As a result of the FDA approval and continued good operational performance,
Covidien is increasing the fiscal 2013 net sales guidance for the
Pharmaceuticals segment from the previous range of 1% to 4% above 2012 to 3%
to 6% above 2012. There are no other changes to Covidien’s previously
announced 2013 guidance. More details will be provided on January 25, 2013,
when the Company announces its first-quarter results.



Methylphenidate HCl ER Tablets are indicated for the treatment of ADHD in
children 6 years of age and older, adolescents and adults up to the age of 65.



Methylphenidate HCl ER Tablets should be given cautiously to patients with a
history of drug dependence or alcoholism. Chronic abusive use can lead to
marked tolerance and psychological dependence with varying degrees of abnormal
behavior. Frank psychotic episodes can occur, especially with parenteral
abuse. Careful supervision is required during withdrawal from abusive use
since severe depression may occur. Withdrawal following chronic therapeutic
use may unmask symptoms of the underlying disorder that may require follow-up.

Methylphenidate HCl ER Tablets are contraindicated in patients:

  *With a known hypersensitivity to the product or its components;
  *With marked anxiety, tension, or agitation;
  *With glaucoma;
  *With tics or a family history or diagnosis of Tourette’s syndrome; and
  *Using or within 2 weeks of using a monoamine oxidase inhibitor

Serious adverse events, including sudden death, stroke and myocardial
infarction, have been reported in patients taking usual doses.

The most common adverse reaction (>5%) reported in children and adolescents
was upper abdominal pain. The most common adverse reactions (>10%) reported in
adults were dry mouth, nausea, decreased appetite, headache and insomnia.

Health care professionals should monitor patients for changes in heart rate
and blood pressure and use with caution in patients for whom an increase in
blood pressure or heart rate would be problematic.

Use of stimulants may cause treatment-emergent psychotic or manic symptoms in
patients with no prior history, or exacerbation of symptoms in patients with
preexisting psychiatric illness. Clinical evaluation for bipolar disorder is
recommended prior to stimulant use. Healthcare professionals should monitor
for aggressive behavior.

Stimulants may lower the convulsive threshold. Discontinue in the presence of

Difficulties with accommodation and blurring of vision have been reported with
stimulant treatment.

Methylphenidate HCl ER Tablets may cause long-term suppression of growth;
monitor height and weight at appropriate intervals in pediatric patients.

Methylphenidate HCl ER Tablets also may cause gastrointestinal (GI)
obstruction with preexisting GI narrowing.

Hematologic monitoring (periodic complete blood count, differential and
platelet counts) are advised during prolonged therapy.



Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers value
through clinical leadership and excellence. Covidien manufactures, distributes
and services a diverse range of industry-leading product lines in three
segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2012
revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70
countries, and its products are sold in over 140 countries. Please visit to learn more about our business.

Mallinckrodt, the Pharmaceuticals business of Covidien, is a vertically
integrated leader in providing products used in diagnostic procedures and in
the treatment of pain and related conditions. The company is the largest U.S.
supplier, by prescription, of opioid pain medications and a leading
manufacturer of active pharmaceutical ingredients. It is also the largest US
supplier of the medical isotope technetium-99m and an industry leader in
radiopharmaceuticals and contrast media and delivery systems. Sales in 2012
were $2.0 billion. Please visit to learn more about our

CONCERTA is a registered trademark of ALZA Corporation.


Any statements contained in this communication that do not describe historical
facts may constitute forward-looking statements as that term is defined in the
Private Securities Litigation Reform Act of 1995. Any forward-looking
statements contained herein are based on our management's current beliefs and
expectations, but are subject to a number of risks, uncertainties and changes
in circumstances, which may cause actual results or Company actions to differ
materially from what is expressed or implied by these statements. The factors
that could cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to effectively
introduce and market new products or keep pace with advances in technology,
the reimbursement practices of a small number of large public and private
insurers, cost-containment efforts of customers, purchasing groups,
third-party payors and governmental organizations, intellectual property
rights disputes, complex and costly regulation, including healthcare fraud and
abuse regulations and the Foreign Corrupt Practices Act, manufacturing or
supply chain problems or disruptions, rising commodity costs, recalls or
safety alerts and negative publicity relating to Covidien or its products,
product liability losses and other litigation liability, divestitures of some
of our businesses or product lines, our ability to execute strategic
acquisitions of, investments in or alliances with other companies and
businesses, competition, risks associated with doing business outside of the
United States, foreign currency exchange rates and environmental remediation
costs. These and other factors are identified and described in more detail in
our Annual Report on Form 10-K for the fiscal year ended September 28, 2012,
and in subsequent filings with the SEC. We disclaim any obligation to update
these forward-looking statements other than as required by law.


Lynn Phillips
Manager, Media Relations
Stephen Littlejohn
Vice President Communications
Coleman Lannum, CFA
Vice President
Investor Relations
Todd Carpenter
Investor Relations
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