The U.S Food and Drugs Administration has granted Plan B manufacturer, Teva Pharmaceuticals, exclusive marketing rights for the morning-after pill for three years.
The decision to grant Teva Pharmaceuticals exclusive marketing rights for the morning-after pill for three years was made Monday night, reports New York Times and comes after the FDA granted permission for sale of Plan B Step-One over the counters to women of all ages without a prescription.
According to the new decision, Teva Pharmaceuticals will be the only company allowed to market the over-the-counter drug . Manufactures of the generic version of the drug can also apply to the FDA for permission but even if given approval, they can market the drug only after Teva Pharmaceuticals' three years exclusivity expires.
Currently, the drug retails for $50 but generic manufacturers usually sell it over the counter for $35 to $40. Previously, the drug was available without a prescription only for ages 17 and older.
However, on June 10, 2013, the FDA notified a United States District Court judge in New York about its intentions to comply with an earlier court order, requesting the agency to make emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.
"Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, in a June press release.
The drug was first made available without a prescription in 2009 to all women above the age of 17. The age limit was brought down to 13 in April 2013. Finally in June, the agency announced the availability of the drug without a prescription to all women with reproductive potential.
