Mallinckrodt Pharmaceuticals Announces Settlement of OFIRMEV® (acetaminophen) Injection Patent Litigation with Fresenius Kabi USA, LLC
The companies are not disclosing specific terms of the settlement and
license agreements, except that Cadence has granted Fresenius Kabi a
non-exclusive right to market an intravenous acetaminophen product in
the U.S. under Fresenius Kabi’s 505(b)(2) New Drug Application on
Other details of the settlement are confidential, and the settlement is
subject to submission to the
"This settlement validates our confidence in the strength and integrity
of the intellectual property covering OFIRMEV," said
OFIRMEV (acetaminophen) injection 100 mL vials, 1000 mg (10 mg/mL)
INDICATIONS AND USAGE
OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.
IMPORTANT RISK INFORMATION
WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
- the dose in milligrams (mg) and milliliters (mL) is not confused;
- the dosing is based on weight for patients under 50 kg;
- infusion pumps are properly programmed; and
- the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.
OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.
Acetaminophen is contraindicated in patients with:
- known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.
- severe hepatic impairment or severe active liver disease.
WARNINGS AND PRECAUTIONS
- Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
- Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min).
- Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
- Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.
- The antipyretic effects of OFIRMEV may mask fever.
- Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
- Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
- Breast Feeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
- Pediatrics: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.
See Full Prescribing Information for additional Important Risk Information including boxed warning.
Cautionary Statements Related to Forward-Looking Statements
Statements in this document that are not strictly historical, including
statements regarding the proposed acquisition, the expected timetable
for completing the transaction, future financial and operating results,
benefits and synergies of the transaction, future opportunities for the
combined businesses and any other statements regarding events or
developments that we believe or anticipate will or may occur in the
future, may be “forward-looking” statements within the meaning of the
Private Securities Litigation Reform Act of 1995, and involve a number
of risks and uncertainties. There are a number of important factors that
could cause actual events to differ materially from those suggested or
indicated by such forward-looking statements and you should not place
undue reliance on any such forward-looking statements. These factors
include risks and uncertainties related to, among other things: general
economic conditions and conditions affecting the industries in which
John Moten, 314-654-6650
Vice President, Investor Relations
Lynn Phillips, 314-654-3263
Meredith Fischer, 314-654-6595
Senior Vice President, Communications