Court upholds Crestor patent
WILMINGTON, Del. The U.S. District Court for the District of Delaware has upheld the patent on a cardiovascular drug made by AstraZeneca, the Anglo-Swedish drug maker said Tuesday.
Judge Joseph Farnan ruled that the substance patent covering the drug Crestor (rosuvastatin calcium), U.S. Patent No. RE37,314, is valid and enforceable. The decision was in response to several companies’ attempts to market generic versions of the drug, including Mylan, Teva Pharmaceutical Industries and Apotex. The decision bars the Food and Drug Administration from approving a generic version of Crestor before the ’314 patent’s expiration, in 2016.
One of the most abbreviated new drug applications filed with the FDA was from India-based generic drug maker, Glenmark Generics. The company was seeking approval for the commercial manufacture, use, importation, offer for sale and sale of rosuvastatin calcium (the active ingredient in Crestor) tablets in 5 mg, 10 mg, 20 mg and 40 mg dosage strengths.
“We are pleased with the court’s decision upholding the validity and enforceability of the ’314 substance patent,” AstraZeneca CEO David Brennan said. “The court’s decision reaffirms the strength of the intellectual property protecting Crestor.”
Teva’s generic Effexor XR receives regulatory approval
SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of an extended-release antidepressant pill made by Pfizer, the agency said Tuesday.
The FDA approved Teva Pharmaceutical Industries’ venlafaxine hydrochloride extended-release capsules. The capsules are a generic version of Effexor XR, used to treat major depressive disorder. The capsules will be available in the 37.5 mg, 75 mg and 150 mg strengths.
“The approval of this widely used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs,” said Keith Webber, FDA Center for Drug Evaluation and Research Office of Pharmaceutical Science deputy director. “Access to treatments for depression is important because depression can interfere with a person’s daily life and routine, which can significantly affect relationships with family and friends.”
Effexor products had sales of $520 million in 2009, according to Pfizer financial data.
NACDS, NCPA back senatorial MTM bill
ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association have voiced their support of the Senate medication therapy management bill, authored and introduced Tuesday by Sen. Kay Hagan, D-N.C., as it aims to further pave the way for enhanced pharmacist-provided MTM services.
Hagan’s Medication Therapy Management Expanded Benefits Act of 2010 would enhance pharmacist-provided MTM services for Medicaid and Medicare beneficiaries by opening MTM services to patients suffering from any chronic condition or disease. Sen. Al Franken, D-Minn., is an original co-sponsor of the bill.
"By encouraging MTM services in neighborhood pharmacies, the bill would improve public health and reduce healthcare costs by helping patients to take their medications in the right ways and avoid complications with their drug therapies," stated NACDS president and CEO Steve Anderson. "Patients suffering from chronic disease, be it diabetes, hypertension, asthma or other conditions, will benefit from these pharmacy services, which also strengthen the pharmacist-patient relationship. We thank Senators Hagan and Franken for their commitment to improving health care in a way that stands to reduce costs and improve lives."
Added Douglas Hoey, NCPA acting EVP and CEO, "For many Medicare Part D patients, the challenges of coping with numerous chronic conditions and diseases require an expert’s consultation, and pharmacists are clinically trained in helping ensure their patients are getting the best possible results. The bill offered by Senators Hagan and Franken is the next logical step in broadening the reach of MTM. NCPA urges the Senate to move expeditiously to pass this bill, because true healthcare reform needs to incorporate all the best practices."
The bill is the Senate’s companion to H.R. 3108, the Medication Therapy Management Benefits Act of 2009, introduced by Rep. Mike Ross, D-Ark., last year and endorsed by NACDS and NCPA.