Cumberland Receives Second Acetadote® Patent Notice of Allowance

       Cumberland Receives Second Acetadote® Patent Notice of Allowance

- New patent provides additional intellectual property protection through 2025

PR Newswire

NASHVILLE, Tenn., Nov. 7, 2012

NASHVILLE, Tenn., Nov. 7, 2012 /PRNewswire/ --Cumberland Pharmaceuticals
Inc.(NASDAQ: CPIX) today announced that it has received a Notice of Allowance
from the United States Patent and Trademark Office for a second patent
relating to its new formulation of Acetadote^® (acetylcysteine) Injection,
which is used to treat acetaminophen overdose. The original composition of
matter patent covered the Acetadote formulation and was issued in April 2012.
The new patent includes claims regarding the use of the 200 mg/ml Acetadote
formulation to treat patients with acetaminophen overdose.

This additional patent represents another significant milestone for Cumberland
and its Acetadote brand. A new formulation of Acetadote was FDA approved in
2011 and listed in the "Orange Book," the FDA's official register of approved
pharmaceutical products. The original Acetadote patent was FDA "Orange Book"
listed as well. The proprietary next generation formula does not contain
Ethylene diamine tetraacetic acid (EDTA) or any other stabilization and
chelating agents and is free of preservatives. This formulation was developed
as part of a Phase IV commitment by Cumberland in response to a request by the
FDA to evaluate the reduction of EDTA from the product's formulation.
Following the approval of the next generation Acetadote product, the Company
immediately ceased manufacture of the previous formulation.

"We believe that the new Acetadote patent represents an important development
in our efforts to protect our intellectual property and defend our product,"
said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals.
"Intellectual property protection is a key objective for the company and we
will continue to seek opportunities to expand our patent portfolio."

Acetadote is used in hospital emergency departments to prevent or lessen
potential liver damage resulting from an overdose of acetaminophen, a common
ingredient in many over-the-counter pain relief and fever-reducing products.
Acetaminophen continues to be the leading cause of poisonings reported by
hospital emergency rooms in the United States, and Acetadote has become a
standard of care for treating this potentially life-threatening condition.

About Acetadote

Acetadote, administered intravenously within 8 to 10 hours after ingestion of
a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent
or lessen hepatic injury. Used in the emergency department, Acetadote is the
only injectable product approved in the United States to treat overdose of
acetaminophen, a common ingredient in many over-the-counter painkillers.
Acetadote is contraindicated in patients with hypersensitivity or previous
anaphylactoid reactions to acetylcysteine or any components of the
preparation. Serious anaphylactoid reactions, including death in a patient
with asthma, have been reported in patients administered acetylcysteine
intravenously. Acetadote should be used with caution in patients with asthma,
or where there is a history of bronchospasm. The total volume administered
should be adjusted for patients weighing less than 40 kg and for those
requiring fluid restriction. To avoid fluid overload, the volume of diluent
should be reduced as needed. If volume is not adjusted, fluid overload can
occur, potentially resulting in hyponatremia, seizure, and death. For full
prescribing information, visit www.acetadote.net.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical
company focused on the acquisition, development and commercialization of
branded prescription products. The Company's primary target markets include
hospital acute care and gastroenterology. Cumberland's product portfolio
includes Acetadote^® (acetylcysteine) Injection for the treatment of
acetaminophen poisoning; Caldolor^® (ibuprofen) Injection, the first
injectable treatment for pain and fever available in the United States; and
Kristalose^® (lactulose) for Oral Solution, a prescription laxative.
Cumberland is dedicated to providing innovative products which improve quality
of care for patients. For more information, please visit the company website
at www.cumberlandpharma.com.

Important Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that reflect
Cumberland's current views with respect to future events, based on what it
believes are reasonable assumptions. No assurance can be given that these
events will occur. As with any business, all phases of operations are subject
to influences outside of the Company's control. Risk factors that could
materially affect results of operations include, among other things, market
conditions, intense competition from existing and new products, an inability
of manufacturers to produce Acetadote on a timely basis or a failure of
manufacturers to comply with stringent regulations applicable to drug
manufacturers, maintaining and building an effective sales and marketing
infrastructure, government regulation, the possibility that patent rights may
provide only limited protection from competition, and other factors related to
the Company including those under the headings "Risk factors" and
"Management's discussion and analysis of financial condition and results of
operations" in Cumberland's Form 10-K filed with the SEC on March 12, 2012.
There can be no assurance that the results or developments anticipated by
Cumberland will be realized or, if realized, that they will have the expected
effects. Readers are cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date hereof. Cumberland undertakes no
obligation to release publicly any revisions to these statements to reflect
events or circumstances after the date hereof.

SOURCE Cumberland Pharmaceuticals Inc.

Website: http://www.cumberlandpharma.com
Website: http://www.acetadote.net
Contact: Investor Contact,Elizabeth Davis, Cumberland Pharmaceuticals,
+1-615-255-0068, investors@cumberlandpharma.com; or Media Contact, Rebecca
Kirkham, Lovell Communications, +1-615-297-7766, rebecca@lovell.com
 
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