Mallinckrodt, the Pharmaceuticals business of
), launched more dosages of the Concerta (methylphenidate HCl)
Extended-Release (ER) Tablets USP (CII). The company introduced
the new 36 mg and 54 mg dosage strengths.
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In Dec 2012, Covidien had won the U.S. Food and Drug
Administration (FDA) approval to manufacture and sell a Concerta
drug in 27 mg, 36 mg and 54 mg dosage strengths. Following the
approval, the company immediately rolled out the 27 mg dosage and
as per its plan introduced the other two in this quarter.
Management believes that it holds a six-month exclusivity period
for each of the respective dosage strengths following its
The tablets are used to treat patients, aged between 6 and 65,
suffering from Attention Deficit Hyperactivity Disorder (ADHD).
ADHD is a neurobehavioral disorder, usually diagnosed in
childhood. Children with ADHD are inattentive, hyperactive and
impulsive. Despite being a long-term chronic condition, it can be
successfully treated with proper therapy and medication.
According to The American Psychiatric Association, roughly 3%-7%
of school children have ADHD.
Mallinckrodt is a leading manufacturer of bulk acetaminophen in
the world and the largest supplier of opioid pain management
drugs in the U.S. It also features in the top 10 list of
prescription-based generic pharmaceuticals manufacturers in the
U.S. Covidien intends to divest Mallinckrodt by mid-2013 in an
effort to focus on its high-margin surgical product portfolio.
Covidien had raised its full year guidance partially based on the
successful FDA approval of the generic Concerta product in Dec
2012. The Pharmaceuticals division is anticipated to grow at a
high single-digit rate or more (earlier 1% to 4%) in fiscal 2013.
However, the company's pharmaceuticals product line faces stiff
competition from companies such as
Johnson & Johnson
Covidien reached a 52-week high of $67.98 on Thursday, Mar 28,
2013. It currently has a Zacks Rank #2 (Buy). Other companies
), carrying a Zacks Rank #2 (Buy), are expected to do well in the