Active Ingredient: Ibrutinib Dosage Forms & Strengths: Capsules: 70 mg and 140 mg Tablets: 140 mg, 280 mg, 420 mg, and 560 mg Mechanism of Action: Bruton's tyrosine kinase Inhibitor (BTKi) First Approval: US (13 Nov 2013), EU (Oct 2014) Revenue Analysis Imbruvica is an oral therapy that inhibits a protein called Bruton's tyrosine kinase. Imbruvica was one of the first medicines to receive US FDA approval after being granted a Breakthrough Therapy Designation and is one of the few therapies to receive four separate designations. Imbruvica is developed jointly by AbbVie and J&J under a 2011 collaboration. According to it, Janssen has an exclusive license to commercialize Imbruvica outside of the United States and co-exclusively with AbbVie in the United States. Both parties are responsible for the development, manufacturing, and marketing of any products generated as a result of the collaboration.