AbbVie 2014 Annual Report Download - page 8

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HUMIRA is also approved in over 60 other markets, including Japan, China, Brazil, and Australia.
HUMIRA was introduced to the market in January 2003. HUMIRA accounted for 63 percent of AbbVie’s total
net sales in 2014. The United States composition of matter (that is, compound) patent covering
adalimumab (which is sold under the trademark HUMIRA) is expected to expire in December 2016, and the
equivalent European Union patent is expected to expire in the majority of European Union countries in
April 2018.
AbbVie continues to dedicate substantial research and development efforts to expanding indications for
HUMIRA, including in the fields of rheumatology, gastroenterology (pediatric Crohn’s disease and
pediatric ulcerative colitis), dermatology (pediatric psoriasis and hidradenitis suppurativa), and
ophthalmology (uveitis). Phase 3 trials are ongoing in preparation for regulatory applications for uveitis in
the United States and the European Union. Regulatory applications for hidradenitis suppurativa have been
filed in the United States and the European Union. AbbVie continues to work on HUMIRA formulation and
delivery enhancements to improve convenience and the overall patient experience.
HCV products. VIEKIRA PAK is an all-oral, short-course, interferon-free therapy, with or without
ribavirin, for the treatment of adult patients with genotype 1 chronic hepatitis C (HCV), including those with
compensated cirrhosis. VIEKIRA PAK was approved by the FDA in December 2014. In Europe, AbbVie’s HCV
treatment is marketed as VIEKIRAX + EXVIERA and is approved for use in patients with genotype 1 and
genotype 4 HCV. The European Commission granted marketing authorization for this treatment in January
2015.
Additional Virology products. AbbVie’s additional virology products include Kaletra and Norvir for the
treatment of HIV infection and Synagis for the prevention of respiratory syncytial virus (RSV) infection in
high risk infants.
Kaletra. Kaletra (also marketed as Aluvia in emerging markets) is a prescription anti-HIV-1
medicine that contains two protease inhibitors: lopinavir and ritonavir. Kaletra is used with other
anti-HIV-1 medications as a treatment that maintains viral suppression in people with HIV-1.
Norvir. Norvir (ritonavir) is a protease inhibitor that is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection.
Synagis. Synagis is a product marketed by AbbVie outside of the United States that protects
at-risk infants from severe respiratory disease caused by RSV.
Metabolics/Hormones products. Metabolic and hormone products target a number of conditions,
including testosterone deficiency, exocrine pancreatic insufficiency and hypothyroidism. These products
include:
AndroGel. AndroGel is a testosterone replacement therapy for males diagnosed with
symptomatic low testosterone that is available in two strengths: 1 percent and 1.62 percent.
Creon. Creon is a pancreatic enzyme therapy for exocrine pancreatic insufficiency, a condition
that occurs in patients with cystic fibrosis, chronic pancreatitis, and several other conditions.
Synthroid. Synthroid is used in the treatment of hypothyroidism.
AbbVie has the rights to sell AndroGel, Creon and Synthroid only in the United States.
Endocrinology products. Lupron (also marketed as Lucrin and Lupron Depot) is a product for the
palliative treatment of advanced prostate cancer, treatment of endometriosis and central precocious
puberty, and for the preoperative treatment of patients with anemia caused by uterine fibroids. Lupron is
approved for daily subcutaneous injection and one-month, three-month, four-month and six-month
intramuscular injection.
22014 Form 10-K