Watson confirms patent challenge for generic Combigan
MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals has applied for Food and Drug Administration approval for a version of a drug used to treat eye diseases, Watson said Tuesday.
Watson announced that subsidiary Watson Labs had filed for approval of brimonidine tartrate and timolol maleate ophthalmic solution in the 0.2%/0.5% strength. The drug is a generic version of Allergan’s Combigan, used to reduce pressure inside the eye, also known as intraocular pressure, in patients with glaucoma or ocular hypertension for whom current or previous therapies are ineffective.
The drug had sales of around $98 million during the 12-month period ended in July, according to IMS Health.
Allergan filed a patent infringement suit against Watson earlier this month in the U.S. District Court for the Eastern District of Texas in order to prevent Watson from marketing its version of the drug before the expiration of four patents covering Combigan, the last of which expires in January 2023, according to FDA records; the exclusivity period for the drug expires at the end of October of this year. Under the Hatch-Waxman Act, Allergan’s lawsuit places a stay on final FDA approval of Watson’s drug for 2.5 years, or until the two companies resolve the matter before the court.
NACDS, NCPA in joint statement praise CMS’ move to withdraw provisions of AMP rule currently blocked by injunction
ALEXANDRIA, Va. National Association of Chain Drug Stores president and CEO Steve Anderson and National Community Pharmacists Association acting EVP and CEO Douglas Hoey issued a statement praising the proposed rule by the Centers for Medicare and Medicaid Services that would withdraw existing provisions of the Medicaid pharmacy reimbursement formula under the average manufacturer price model.
"We are pleased that the Centers for Medicare and Medicaid Services has proposed a rule that would withdraw provisions of what is known as the Medicaid average manufacturer price rule. The proposed rule calls for the withdrawal of existing provisions that define AMP, that determine the calculation of federal upper limits, and that define ‘multiple source drug.’ Put simply, all of these provisions relate to the reimbursement to pharmacies for generic Medicaid prescriptions, and thus impact patients’ access to pharmacies. The move to withdraw these provisions is a victory for patient care as it is delivered in America’s pharmacies every day."
"When we filed the lawsuit in 2007 we knew that patient care was at stake. It is important to point out that the withdrawal of these provisions is another step toward reducing what would have been major cuts to pharmacy reimbursement. The end result is not an increase in reimbursement to pharmacy, but rather the lessening of cuts that previously would have involved pharmacies selling most generic drugs at a loss, thereby threatening their long-term ability to provide patient care."
“We insisted that this policy was not appropriate. Separately, we also have urged that policy-makers should recognize the ability of pharmacies and pharmacists to help improve health and reduce healthcare costs. We are gratified that this sense is reflected in the pharmacy provisions of the new healthcare-reform law. The new law contains provisions ranging from dramatically reducing the AMP cuts to advancing medication therapy management, through which pharmacists can help patients take their medications correctly. … The costs related to poor medication adherence have been estimated to reach $290 billion annually, or 13% of all healthcare expenditures. We urged that patient care should not be jeopardized, but rather that pharmacy be engaged more strategically for the good of patient health and healthcare delivery."
“We anticipate issuing formal comments on CMS’ proposed rule to withdraw these provisions of the AMP rule, and we will continue to work with Congress and with CMS to advocate for access to pharmacy services for patients.”
Omron Healthcare, Dr. Oz team up to underscore home blood-pressure monitoring
BANNOCKBURN, Ill. Omron Healthcare has joined forces with "The Dr. Oz Show" in an integrated media partnership to help spread the word about the importance of home blood pressure monitoring, Omron announced Thursday.
“High blood pressure is a growing concern in the United States among adults, and is often referred to as the ‘silent killer,’” stated Ranndy Kellogg, Omron Healthcare VP marketing and product development. “We’re thrilled to align with ‘America’s Doctor’ in the Sept. 7 season premier to help spread the word about the importance of home blood pressure monitoring, further helping to decrease the risk of heart disease and increase life expectancy.”
The Omron Healthcare integration includes a sponsored segment on "The Dr. Oz Show’s" premiere episode, in addition to a consumer incentive that will be revealed by Dr. Oz during the show. The first 50,000 visitors to DoctorOz.com will be able to download a $10 coupon good on any Omron Healthcare home blood pressure monitor at participating retailers.
The second season of "The Dr. Oz Show" will stress to viewers to “Know Your Five,” and blood pressure is one of those lifesaving numbers Americans need to know. As many as 1-in-3 people suffer from high blood pressure, according to the American Heart Association. And, research showed home blood pressure monitoring can be vital to reducing a patient’s risk of stroke, heart attack, heart failure or kidney failure.
Monitoring blood pressure at home is an important measure people can take to reduce their risk of a heart attack or stroke. More than 50% of people with high blood pressure who monitor at home show an improvement in medication compliance and are quicker to take action.