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Insight & Intelligence™ : Apr 8, 2013

Top 20 Best-Selling Drugs Approved and Launched During 2012

What new medicines are shaking things up?

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

#10. Linzess™ (linaclotide)

2012 sales: $19.2 million9

Marketer(s): Ironwood Pharmaceuticals and Forest Laboratories

Indication(s): Irritable bowel syndrome with constipation and chronic idiopathic constipation in adults

Date of FDA approval: August 30, 2012

#9. Erivedge® (vismodegib)

2012 sales: $30.9 million (CHF 29 million)10

Marketer(s): Roche (Genentech)

Indication(s): Advanced basal cell carcinoma in adults who cannot have surgery or radiation therapy

Date of FDA approval: January 30, 2012

#8. Zaltrap® (ziv-aflibercept)

2012 sales: $32.3 million (€25 million)11

Marketer(s): Sanofi and Regeneron

Indication(s): Metastatic colorectal cancer in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI) chemotherapy regimen

Date of FDA approval: August 3, 2012

Date of European Commission approval: February 5, 2013

#7. Stivarga™ (regorafenib)

2012 sales: $41.4 million (€32 million)12,13

Marketer(s): Bayer HealthCare and Onyx Pharmaceuticals

Indication(s): Metastatic colorectal cancer in patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy

Date of FDA approval: September 27, 2012

#6. Stribild™ (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)

2012 sales: $57.536 million14

Marketer(s): Gilead Sciences

Indication(s): HIV-1 infection in adults who are antiretroviral treatment-naïve

Date of FDA approval: August 27, 2012

#5. Perjeta® (pertuzumab)

2012 sales: $59.7 million (CHF 56 million)15

Marketer(s): Roche (Genentech)

Indication(s): First-line treatment of HER2-positive metastatic breast cancer in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease, in combination with Herceptin® (trastuzumab) and docetaxel

Date of FDA approval: June 8, 2012

Date of European Commission approval: March 5, 2013

#4. Kyprolis® (carfilzomib)

2012 sales: $64 million

Marketer(s): Onyx Pharmaceuticals

Indication(s): Multiple myeloma in patients who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy

Date of FDA approval: July 20, 2012

#3. Inlyta® (axitinib)

2012 sales: $70.1 million16

Marketer(s): Pfizer

Indication(s): Advanced renal cell carcinoma after failure of one prior systemic therapy

Date of FDA approval: January 27, 2012

Date of European Commission approval: September 4, 2012

#2. Xtandi® (enzalutamide)

2012 sales: $71.5 million

Marketer(s): Medivation and Astellas Pharma

Indication(s): Metastatic, castration-resistant prostate cancer in men who have previously received treatment with docetaxel

Date of FDA approval: August 31, 2012

#1. Kalydeco™ (ivacaftor)

2012 sales: $171.6 million

Marketer(s): Vertex Pharmaceuticals

Indication(s): Cystic fibrosis (CF) in patients 6 years old and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator (CFTR) gene

Date of FDA approval: January 31, 2012

Date of European Commission approval: July 23, 2012