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"At-risk" generic launches can be unpredictable
"At-risk" generic launches refer to generic pharmaceuticals that are approved by FDA based on the review of an abbreviated new drug application (ANDA) and are subsequently launched while patent litigation is ongoing.
Key Points
"At-risk" generic launches refer to generic pharmaceuticals that are approved by FDA based on the review of an abbreviated new drug application (ANDA) and are subsequently launched while patent litigation is ongoing. Launching these generics is risky because they can be pulled from the market if courts determine that patents protecting a branded reference product are violated or infringed, thus allowing the brand company to seek triple monetary damages.
The key implication of at-risk generic launches is that they create conditions of unpredictability and confusion, said Diana Papshev, PharmD, partner, InformaCeutica ( http://DrugManagementForum.com/), Yardley, Pa., at the 22nd annual meeting of the Academy of Managed Care Pharmacy in San Diego. "Formulary management becomes challenging in this unpredictable environment where at-risk generics might undergo market withdrawal due to the patent litigation outcomes. Uncertainty about generic product availability also creates confusion in the retail pharmacy setting. In fact, surveys show that more than 50% of retail pharmacists are uncomfortable with dispensing at-risk generics."
In the case of ANDAs submitted by generic pharmaceutical companies with a Paragraph IV certification (which basically challenge existing patents), the law grants brand manufacturers a 30-month waiting period in the form of a stay on FDA approval to pursue a generic company that may be infringing on their patent. Once litigation is initiated, companies might settle, courts may affirm contested patents, courts may find in favor of the generic companies, or the 30-month stay can expire prior to case resolution. The last two options can trigger FDA approval even if litigation is still on-going.
Implications for managed care include unpredictability of forecasting products, contract negotiations and formulary management issues, as well as market confusion.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
