Merck gained the following approvals in 2009-2010:

• In August 2009, the FDA approved Saphris (asenapine) for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. In September 2010, two sNDAs for Saphris were approved in the United States to expand the product's indications to the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. In September 2010, asenapine, to be sold under the brand name Sycrest, received marketing approval in the EU for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
• In June 2010, the FDA approved Dulera Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. Dulera combines an inhaled corticosteroid with a long-acting beta2-agonist.
• In September 2010, the intravenous formulation of Brinavess was granted marketing approval in the EU, Iceland and Norway for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: for nonsurgery patients with atrial fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less. Brinavess acts preferentially in the atria and is the first product in a new class of pharmacologic agents for cardioversion of atrial fibrillation to launch in the EU.

Patents

Merck filed 308 and 220 original U.S. patent applications in 2009 and 2010, respectively. The number of U.S. patents granted during that same periods was 278 and 331, respectively. Many of these patents were related to compounds in various stages of development. The number of filings and patents granted demonstrates the extent of innovation taking place at Merck Research Laboratories.