Opinion ID: 3217049
Heading Depth: 3
Heading Rank: 1

Heading: Absorica

Text: Ranbaxy is the manufacturer of Absorica, an Isotretinoin-based product used to treat serious acne and other skin diseases. Although Absorica shares many features with other generic acne treatments, it is unique in that it is effective even if taken without meals (in a “fasted state”). The FDA issues a publication called the “Orange Book,” which is used by pharmacists in many states to help identify which drugs are interchangeable with other drugs. The Orange Book provides a wide range of information about drugs approved by the FDA, but only two metrics are relevant here: pharmaceutical 2 Case: 15-12996 Date Filed: 06/24/2016 Page: 3 of 20 equivalence and therapeutic equivalence. Two drugs are pharmaceutical equivalents if “they contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or concentration.” App. 74-8 at vi–vii. The Orange Book designates Absorica as pharmaceutically equivalent to several other Isotretinoin-based acne medications. By contrast, two drugs are therapeutic equivalents if “they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.” App. 74-8 at vii. Because of Absorica’s unique effectiveness when taken in a fasted state, the Orange Book has given Absorica a “BX” rating, which indicates that no drugs are therapeutically equivalent to Absorica. The Orange Book is used in many states as the authoritative source for determining whether a pharmacist may substitute a prescribed drug with a cheaper generic version. In “Orange Book states,” pharmacists may only substitute a drug for another if the two drugs are designated by the Orange Book as being therapeutic equivalents. However, in “non-Orange Book states,” pharmacists are not required to consult the Orange Book (though they may choose to do so), and instead make substitution decisions by relying on their own professional judgment and the information provided by their companies’ software programs. 3 Case: 15-12996 Date Filed: 06/24/2016 Page: 4 of 20