Par wins Zegerid patent suit
WOODCLIFF LAKE, N.J. The U.S. District Court for the District of Delaware has ruled in favor of generic drug maker Par Pharmaceutical in a patent litigation suit over a drug used to treat acid reflux, Par announced Thursday.
The court ruled that the University of Missouri’s patents covering omeprazole and sodium bicarbonate capsules in the 20-mg/1.1-g and 40-mg/1.1-g strengths and oral suspension powders in the 20-mg/1.68-g and 4- mg/1.68-g strengths are invalid. The Food and Drug Administration recently was granted tentative approval for both strengths of the capsule version.
Omeprazole and sodium bicarbonate is a generic version of Santarus’s drug Zegerid. Patents for the capsules and oral suspension powder are set to expire in 2016, according to FDA records. According to Santarus financial data, Zegerid capsules and oral suspension powder had combined sales of $119.3 million in 2009.
Santarus said Wednesday that it would appeal the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit.
Take Care Health Systems to offer blood pressure screenings through May
CONSHOHOCKEN, Pa. Take Care Health Systems has announced that it now is offering free blood pressure screenings at all of its 359 Take Care Clinics nationwide through May 31.
The free screenings are available to all patients 18 years and older. If a patient’s blood pressure is elevated, the provider will recommend a return visit to a Take Care Clinic or follow-up with a primary care provider to rule out or confirm a diagnosis of hypertension. If a patient does not have a primary care provider, the Take Care health provider will offer a list of area providers accepting new patients.
"Nearly 22% of individuals in the United States with hypertension are unaware of their condition, according to the American Heart Association," stated Sandy Ryan, chief nurse practitioner officer for Take Care Health Systems, which is owned by Walgreens. "Take Care nurse practitioners and physician assistants will provide free blood pressure screenings to identify at-risk patients, and refer them to the appropriate level of care for treatment. In addition, Take Care health providers will serve as an educational resource to answer questions about hypertension and risk factors associated with the disease."
A majority of Americans with hypertension are untreated or under-treated, potentially unaware that their current behavior and treatment may not be generating adequate results. There are several lifestyle modifications a person can make, including smoking cessation, weight loss if overweight and an increase in physical activity.
"High blood pressure increases the risk of heart attack, heart failure, stroke and kidney disease. Given the accessibility and convenience of Take Care Clinics across the country, we can play a vital role in identifying individuals with undiagnosed or untreated hypertension, helping to decrease the risk for cardiovascular disease," stated Peter Miller, president and CEO of Take Care Health Systems. "These free blood pressure screenings reinforce Take Care Clinics’ commitment to offering quality healthcare services that meet the needs of patients and their families."
In February, Walgreens and Take Care Clinics offered free blood pressure glucose screenings at thousands of locations across the country, offering a convenient access point to receive diabetes awareness and education.
The company expects to unveil later this summer additional efforts screen, diagnose and treat hypertension.
Teva, Pozen reach settlement for Treximet patent
CHAPEL HILL, N.C. The U.S. subsidiary of generic drug maker Teva Pharmaceutical Industries has reached a settlement with Pozen in a patent-infringement suit over a migraine drug, Pozen announced Wednesday.
Teva had filed a regulatory approval application for a generic version of Treximet (sumatriptan and naproxen sodium) with the Food and Drug Administration containing a legal assertion that the drug’s patents were invalid, unenforceable or would not be infringed by a generic version, also known as a Paragraph IV certification. Under the Hatch-Waxman Act of 1984, which created an abbreviated approval pathway for generic pharmaceuticals, Pozen filed the suit against Teva in the U.S. District Court for the Eastern District of Texas. GlaxoSmithKline markets Treximet in the United States under a licensing agreement with Pozen.
Under the agreement, Teva will be removed from the lawsuit, which Pozen also filed against Par Pharmaceutical, Alphapharm and Dr. Reddy’s Labs, but will still be bound by the outcome of the suit or any resulting settlement, Pozen said.
Patents covering Treximet expire in 2025, according to FDA records.