Three Major Antipsychotic Drugs Lose Patent Protection

By Joseph Mandour on January 9, 2012

Patent Attorney Los Angeles – Zyprexa (olanzapine) recently lost its patent protection, to be joined by Geodon (ziprasidone) and Seroquel IR (quetiapine) in March 2012. This past October, the U.S. Food and Drug Administration (FDA) approved the first set of generic olanzapine tablets. Patients in the United States can purchase them at most pharmacies. Experts estimate generic versions of all three drugs will enter the market at a 20-50% lower cost.

Prices will not drop immediately because the manufacturers of generic drugs are usually awarded six months of exclusive distribution rights. However, long-term, the availability of generics will translate into substantial savings for Medicaid agencies and for patients who pay out-of-pocket. Patients not covered by insurance may be able to purchase and benefit from these drugs for the first time. Medicaid Part D plan insurers could also realize savings. Since reimbursement rates are adjusted retroactively, insurers could pocketed a price difference when prices drop during the first year.

Prescription antipsychotic drugs rank highly on the list of most expensive medication. They constitute approximately one-third of most Medicaid pharmacy budgets. In 2010, special brand antipsychotics accounted for $5.3 billion of overall bipolar drug sales. Seroquel, Abilify, and Zyprexa lead the market as top revenue-generating drugs.

The pharmaceutical companies that developed these antipsychotic medications may see a large decline in their market share as generics become available. The markets covered will include the U.S., Japan, the UK, Italy, France, Spain, and Germany. In the United States, the market could drop to $3.1 billion, down from $5.8 billion. Globally, the market for bipolar disorder drugs could drop to $4 billion in 2020, down from $6.5 billion in 2010.

Patients that switch to generics may also notice a difference in the way they are being treated. The availability of a large mix of generic products could allow doctors to specifically tailor a treatment plan for a patient by prescribing a larger variety of drugs in more specific doses. Antipsychotics are used to treat disorders such as bipolar depression, schizophrenia and mania, but they have a wide range of efficacy and produce different side effects such as weight gain, diabetes, cardiac disease and sedation. Many doctors prefer to prescribe a mix of medication, such as a sedative combined with a drug with a low weight-gain effect and a drug with a low diabetes link. As generics enter the market, pharmacists will have to keep up with changes in drug combinations. The doctor, pharmacist and patient will need to monitor for side effects and the efficacy of treatment.

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Posted in: Patent Registration