Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Find out which treatments are the biggest sellers.

Following is a list of 20 FDA-approved treatments for patients with diabetes ranked by their 2013 sales, as reported by the companies that market them. Drugs are listed by name, sponsor(s), and sales data.

Missing from the list are several treatments which were either launched last year with no sales numbers furnished by their marketers, or were launched this year. An example of the former is Johnson & Johnson’s Invokana (canagliflozin), which the company said enjoyed “strong sales” last year, without disclosing a figure. The closest to an actual number is a widely quoted estimate by Wells Fargo analyst Lawrence Biegelson projecting that Invokana was to have generated $122 million in first-year 2013 sales.

Next year’s list could include several diabetes products approved this year. Two examples of these are Boehringer Ingelheim’s Jardiance (empagliflozin), a sodium glucose co-transporter 2 (SGLT2) inhibitor for type 2 diabetes in adults; and Eli Lilly’s Trulicity (dulaglutuide), a weekly glucagon-like peptide-1 (GLP-1) receptor agonist for adults with type 2 diabetes.

The FDA also approved AstraZeneca’s SGLT2 inhibitor Farxiga (dapagliflozin) on January 8—two months after the European Commission gave its nod to the drug under the trade name Forxiga. Farxiga/Forxiga was developed through AstraZeneca’s former diabetes alliance with Bristol-Myers Squibb, until BMS sold its interest to AZ in a deal completed February 1 and valued at up to $4.3 billion. A twice-daily combination treatment of dapagliflozin and metformin, trade-named Xigduo, won European marketing authorization on January 22, 2014, while a once-daily formulation, Xigduo XR, got FDA’s nod on October 29 and earlier gained Australian approval.

The EC in September approved Novo Nordisk’s Xultophy, a once-daily single injection combination of Victoza (liraglutide), which appears on this year’s list—and, Tresiba (insulin degludec), which was rejected last year by the FDA but has been marketed in Europe since early 2013. The FDA, however, insisted on another clinical trial assessing Tresiba and a second Novo combo candidate, Ryzodeg (insulin degludec/insulin aspart).

#20. Apidra® (insulin glulisine [rDNA origin] injection)

Company: Sanofi

2013 sales: $364 million (€288 million)

#19. Nesina® (alogliptin)1

Company: Takeda Pharmaceutical

2013 sales: $395.2 million (¥43.0 billion)

#18. Actos® (pioglitazone)

Company: Takeda Pharmaceutical

2013 sales: $397.0 million (¥43.2 billion)

#17. Bydureon® (exenatide extended-release for injectable suspension)

Company: Bristol-Myers Squibb2,3

2013 sales: $449 million ($298 million BMS + $151 million AstraZeneca)

#16. Amaryl®

Company: Sanofi

2013 sales: $474 million (€375 million)

#15. Glucophage® (metformin)

Company: Merck KGaA and Bristol-Myers Squibb4

2013 sales: $498 million (€394 million) reported by Merck KGaA’s Merck Serono unit

#14. Tradjenta® / Trajenta® (linagliptin) and Jentadueto® (Trajenta [linagliptin] + metformin)

Company: Boehringer Ingelheim and Eli Lilly5

2013 sales: $599 million (€474 million) reported by Boehringer Ingelheim5

#13. Byetta® (exenatide)

Company: Bristol-Myers Squibb6,7

2013 sales: $606 million ($400 million BMS + $206 million AstraZeneca)

#12. Galvus® (vildagliptin)

Company: Novartis

2013 sales: $1.2 billion

#11. Onglyza® (saxagliptin) + Kombiglyze™ XR/Komboglyze (saxagliptin and metformin HCl extended release)10

Company: Bristol-Myers Squibb and AstraZeneca,8,9 Kyoza Hakko Kirin (Japan)

2013 sales: $1.265 billion ($877 million from both products by BMS + $378 million from Onglyza by AstraZeneca + $10.107 million [¥1.1 billion] from Onglyza by Kyowa Hakko Kirin)

#10. Humulin® (human insulin [rDNA origin])

Company: Eli Lilly

2013 sales: $1.316 billion

#9. NovoMix® / NovoLog® Mix (insulin aspart [rys])

Company: Novo Nordisk

2013 sales: $1.658 billion (DKK 9.759 billion)

#8. Janumet® (sitagliptin and metformin)

Company: Merck & Co.

2013 sales: $1.829 billion

#7. Human insulins11

Company: Novo Nordisk

2013 sales: $1.846 billion (DKK 10.869 billion)

#6. Levemir® (insulin detemir [rDNA origin] injection)

Company: Novo Nordisk

2013 sales: $1.961 billion (DKK 11.546 billion)

#5. Victoza® (liraglutide [rDNA origin] injection)

Company: Novo Nordisk

2013 sales: $1.976 billion (DKK 11.633 billion)

#4. Humalog® (insulin lispro injection, USP [rDNA origin])

Company: Eli Lilly

2013 sales: $2.611 billion

#3. NovoLog® / NovoRapid® (Insulin aspart [rDNA origin] injection)

Company: Novo Nordisk

2013 sales: $2.861 billion (DKK 16.848 billion)

#2. Januvia® (sitagliptin)

Company: Merck & Co.

2013 sales: $4.004 billion

#1. Lantus® (insulin glargine)

Company: Sanofi

2013 sales: $7.229 billion (€5.715 billion)

All non-U.S. currencies converted to USD on October 29, 2014.

Notes:
1 In the U.S. / Europe, Takeda has won additional approvals to market two combination treatments that include Nesina: Oseni / Incresync® (fixed-dose combination tablet of alogliptin and Actos (pioglitazone), and Kazano® / Vipdomet (fixed-dose combination tablet of alogliptin and metformin).
2 In 2013, the drug was jointly marketed by Bristol-Myers Squibb and AstraZeneca through their diabetes alliance. On February 1, AstraZeneca completed its acquisition of Bristol-Myers Squibb’s interests in the alliance. AstraZeneca paid BMS $2.7 billion upfront, and agreed to pay another $1.4 billion tied to regulatory, launch, and sales-based milestones—of which $600 million relates to the approval of Farxiga in the U.S—and up to $225 million tied to the transfer of assets.
3 BMS acquired the drug’s original developer, Amylin Pharmaceuticals, in a deal completed August 8, 2012
4 Licensed to BMS by Merck KGaA. Companies expanded their collaboration to China, where they agreed in March 2013 to promote Glucophage under different formulations.
5 Co-developed and co-commercialized by Boehringer Ingelheim and Eli Lilly, which recorded $249.2 million in collaboration revenue in connection with Tradjenta.
6 In 2013, the drug was jointly marketed by Bristol-Myers Squibb and AstraZeneca through their diabetes alliance. On February 1, AstraZeneca completed its acquisition of Bristol-Myers Squibb’s interests in the alliance. AstraZeneca paid BMS $2.7 billion upfront, and agreed to pay another $1.4 billion tied to regulatory, launch, and sales-based milestones—of which $600 million relates to the approval of Farxiga in the U.S—and up to $225 million tied to the transfer of assets.
7 BMS acquired the drug’s original developer, Amylin Pharmaceuticals, in a deal completed August 8, 2012.
8 Onglyza was internally discovered by BMS, while Kombiglyze was co-developed by BMS and AstraZeneca.
9 In 2013, the drug was jointly marketed by the companies through their diabetes alliance. On February 1, AstraZeneca completed its acquisition of Bristol-Myers Squibb’s interests in the alliance. AstraZeneca paid BMS $2.7 billion upfront, and agreed to pay another $1.4 billion tied to regulatory, launch, and sales-based milestones—of which $600 million relates to the approval of Farxiga in the U.S—and up to $225 million tied to the transfer of assets.
10 BMS does not break out sales of the two drugs.
11 Includes Insulatard®, Actrapid®, and Mixtard® 30

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