Oral Contraceptives
In the U.S., Barr currently manufactures and markets 25 generic oral
contraceptive products under trade names including Aviane®, Kariva® and Tri-Sprintec®. In Canada in 2007,
the Company received approval for and launched the first ever generic oral contraceptive product, Portia®, for
Canadian women under an agreement with its partner, Apotex. Later in the year, Barr and Apotex launched a second
generic oral contraceptive product, Aviane™.
In the U.S., the Company's oral contraceptives compete with the branded
versions of the products and, in most instances, with other generic products and/or "authorized" generic versions of the
branded product. "Authorized" generics are generic products manufactured under the brand pharmaceutical company's New Drug
Application (NDA) and sold either by the brand company itself or through a licensee.
Oral contraceptives are the most common method of reversible birth control,
used by approximately 82% of women in the U.S. at some time during their reproductive years. Oral contraceptives have a long history
with widespread use attributed to many factors, including efficacy in preventing pregnancy, safety and simplicity in initiation and
discontinuation, medical benefits and relatively low incidence of side effects. According to industry sources, the U.S. oral
contraceptive market had sales of approximately $3.4 billion during 2007.