The US Food and Drug Administration (FDA) has given Teva Women's Health, the manufacturer of the controversial Plan B One-Step (levonorgestrel) drug that recently won over-the-counter status after years of contentious legal battles, three years of market exclusivity during which time no generic products may be marketed using the OTC indication, FDA has announced.

Background

The development, first announced by The Boston Globe, was found within FDA's Orange Book, a publication containing all exclusivity and patent use codes that acts as a reference for the development of generic drug products. Teva's Plan B One-Step, approved under application #021998, was originally approved on 10 July 2009. A prior version of the drug, a two-pill version known only as Plan B, was approved in 2006 under application #021045.

Under federal law and FDA regulations, if a company obtains approval for a new drug application that relied upon studies for approval, it can be eligible for several years of market exclusivity, generally five years for a new molecular entity or three years for all other new drugs.

While some products can be "switched" to OTC status by virtue of having been on the market for a meaningful time and to a meaningful extent (known as time and extent, or TEA, applications) or approved by petitioning FDA through a Citizen Petition, Teva's application was conducted through a new drug application (NDA).

While that NDA was tentatively approved by FDA in December 2011, the approval was immediately struck down by Kathleen Sebelius, secretary of the US Department of Health and Human Services, who said the application lacked sufficient use data to show it would be safe for younger women around the age of 12.

Exclusivity Support

Teva then came back with that data, and on 30 April 2013 FDA said it had granted approval to Teva's One-Step product for all women 15 years of age and older. Weeks later, on 20 June 2013, FDA dropped its opposition to a court case, granting Teva wider approval for the drug, which is now approved for use in women of all ages.

That left Teva in something of a strange situation: It stood to obtain exclusivity for the 15-and-older indication, but the court order for approval had made no mention of exclusivity for the wider indication covering all ages.

However, the Orange Book update shows that Teva has now obtained a new exclusivity date of 30 April 2016-three years after the date of its approval for the 15 years of age indication.

A statement made by FDA explained that the exclusivity applies to "nonprescription use in women age 16 and below," creating something of an odd discrepancy: The exclusivity date covers all ages despite that approval only having occurred on 20 June 2013-not 30 April 2013, the date on which the exclusivity provision is based.

Regardless of the date itself, the decision to grant exclusivity, The Boston Globe reported, was ultimately based on the clinical trials data Teva provided in support of the application. Under the Hatch-Waxman Act of 1984, any drug approved based on clinical trials sponsored by the applicant that were "essential to approval" (i.e. "there are no other data available that could support approval of the application") is eligible for three years of market exclusivity.

It would seem FDA found such studies essential to approval, especially since failing to have them in 2011 literally prevented Teva from obtaining approval.

Orange Book Posting

Plan B Background

Boston Globe Story