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Top 20 Best-Selling Drugs Approved and Launched During 2012

What new medicines are shaking things up?

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You’ve seen GEN’s list of the top 20 best-selling drugs of 2012, but what brand new drugs have come out over the past year that are worth watching? Here are top 20 best-selling drugs that were approved and launched during 2012, ranked by their 2012 sales. Data on 2012 comes in most cases from the companies themselves, except where otherwise noted. Drugs are listed by both trade name and generic or active pharmaceutical ingredient name. Accompanying each listing is the marketer(s) of the drug, the drug’s indication, and date of FDA and/or European Commission approval.

#20. Qsymia® (phentermine and topiramate extended-release)

2012 sales: $2 million

Marketer(s): Vivus

Indication(s): Chronic weight management in adults with an initial body mass index (BMI) of30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. Should be used together with diet and exercise

Date of FDA approval: July 17, 2012

#18 (tie). Xeljanz® (tofacitinib citrate)

2012 sales: $3 million¹

Marketer(s): Pfizer and Takeda

Indication(s): Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Date of FDA approval: November 6, 2012

Date of Japan Ministry of Health, Labor and Welfare approval: March 25, 2013

#18 (tie). Signifor® (pasireotide)

2012 sales: $3 million²

Marketer(s): Novartis

Indication(s): Cushing’s disease in adult patients for whom pituitary surgery is not an option or has not been curative

Date of European Commission approval: April 25, 2012

Date of FDA approval: December 14, 2012

#17. Belviq® (lorcaserin hydrochloride)

2012 sales: $6 million³

Marketer(s): Arena Pharmaceuticals and Eisai

Indication(s): Chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m² or greater (obese), or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes), in addition to diet and exercise

Date of FDA approval: June 27, 2012

#16. Aubagio® (teriflunomide)

2012 sales: $9.1 million (€7 million)⁴

Marketer(s): Sanofi (Genzyme)

Indication(s): Relapsing forms of multiple sclerosis

Date of FDA approval: September 12, 2012

#15. Fycompa® (perampanel)

2012 sales:$12 million⁵

Marketer(s): Eisai

Indication(s): Partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older

Date of European Commission approval: July 23, 2012

Date of FDA approval: October 22, 2012

#14. Tudorza™ Pressair™ (aclidinium bromide)

2012 sales: $12.2 million⁶

Marketer(s): Forest Laboratories

Indication(s): Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

Date of FDA approval: July 23, 2012

#13. Voraxaze® (glucarpidase)

2012 sales: $14 million

Marketer(s): BTG International

Indication(s): Toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function

Date of FDA approval: January 17, 2012

#12. Bosulif® (bosutinib)

2012 sales: $15 million⁷

Marketer(s): Pfizer

Indication(s): Chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy

Date of FDA approval: September 4, 2012

Date of European Commission conditional approval: March 28, 2013

#11. Elelyso™ (taliglucerase alfa)

2012 sales: $18 million⁸

Marketer(s): Protalix BioTherapeutics and Pfizer

Indication(s): Long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type 1 Gaucher disease

Date of FDA approval: May 1, 2012

Date of European Commission rejection: November 1, 2012, citing the EU market exclusivity until 2020 of a competing agent from Shire