Glargine U300 — Competitive Intelligence Brief

Glargine U300 (Glargine U300) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting basal insulin analog. Area: Diabetes.

marketed Long-acting basal insulin analog Insulin receptor Diabetes Small molecule

Target snapshot

Glargine U300 (Glargine U300) — University of Split, School of Medicine. Glargine U300 is a long-acting basal insulin that binds to insulin receptors to promote glucose uptake and utilization in peripheral tissues while suppressing hepatic glucose production.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Glargine U300 TARGET	Glargine U300	University of Split, School of Medicine	marketed	Long-acting basal insulin analog	Insulin receptor
Tresiba	INSULIN DEGLUDEC	Novo Nordisk	marketed	Insulin Analog [EPC]	Insulin receptor	2015-01-01
Levemir	INSULIN DETEMIR	Novo Nordisk	marketed	Insulin Analog [EPC]	Insulin receptor	2005-01-01
Apidra	INSULIN GLULISINE	Sanofi	marketed	Insulin Analog [EPC]	Insulin receptor	2004-01-01
Lantus	INSULIN GLARGINE	Sanofi	marketed	Insulin Analog [EPC]	Insulin receptor	2000-01-01
Novolog	INSULIN ASPART	Novo Nordisk	marketed	Insulin Analog [EPC]	Insulin receptor	2000-01-01
Humalog	INSULIN LISPRO	Eli Lilly	marketed	Insulin Analog [EPC]	Insulin receptor	1996-01-01

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Long-acting basal insulin analog class)

1. Novo Nordisk A/S · 2 drugs in this class
2. Institut de Recherches Cliniques de Montreal · 1 drug in this class
3. Jiangsu HengRui Medicine Co., Ltd. · 1 drug in this class
4. Les Laboratoires des Médicaments Stériles · 1 drug in this class
5. Merete Bechmann Christensen · 1 drug in this class
6. Nanjing First Hospital, Nanjing Medical University · 1 drug in this class
7. Sydney Children's Hospitals Network · 1 drug in this class
8. The Cleveland Clinic · 1 drug in this class
9. Gan & Lee Pharmaceuticals. · 1 drug in this class
10. University of Split, School of Medicine · 1 drug in this class