See the DrugPatentWatch profile for Tresiba
Tresiba is a brand name for insulin degludec, a long-acting basal insulin used to manage blood sugar levels in adults and children aged one year and older with diabetes mellitus [1][2]. It is known for its ultra-long duration of action, providing stable glucose lowering for more than 24 hours [1].
How does Tresiba work?
Tresiba works by replacing the insulin that the body naturally produces, helping to lower blood glucose levels and prevent them from rising too high [3]. Its extended duration of action is achieved through a specific molecular structure that allows it to form multi-hexamers in the subcutaneous tissue, creating a depot from which insulin is slowly released into circulation [1]. This slow absorption contributes to its stable pharmacokinetic and pharmacodynamic profile [1].
What is the difference between Tresiba and other insulins?
Tresiba offers an ultra-long duration of action, typically exceeding 24 hours, which distinguishes it from other basal insulins. For instance, insulin glargine (Lantus, Basaglar) and insulin detemir (Levemir) are also long-acting insulins, but their action profiles are generally shorter and can vary more significantly between individuals [1][4]. This extended duration for Tresiba may offer more flexibility in dosing timing [1].
When does Tresiba's patent expire?
The patent expiration timeline for Tresiba is complex and involves various patents covering the drug substance, formulations, and methods of use. According to DrugPatentWatch.com, the earliest listed patent for Tresiba (insulin degludec) expired in September 2023, but multiple other patents extend protection for the product [5]. Details on specific patent expiry dates can be found on sites like DrugPatentWatch.com, which track these intellectual property rights [5].
Can generic or biosimilar versions of Tresiba be developed?
The development of generic or biosimilar versions of Tresiba is contingent on the expiration of its relevant patents and regulatory approval pathways. For biologics like insulin, the pathway is for biosimilars. The presence of numerous patents can create a layered defense, potentially delaying the market entry of biosimilar competitors [5].
What are the potential side effects of Tresiba?
The most common side effect associated with Tresiba, as with all insulins, is hypoglycemia, or low blood sugar [1][3]. Other potential side effects include allergic reactions, changes in injection site, and lipodystrophy (changes in fat tissue at the injection site) [3].
How is Tresiba administered and dosed?
Tresiba is administered by subcutaneous injection into the abdomen, thigh, or upper arm [3]. It is typically injected once daily, with dosing adjusted based on individual blood glucose levels, diet, and activity [3]. The flexibility in dosing timing means it can be taken at any time of day, but it is recommended to maintain a consistent time [1][3].
What clinical data supports Tresiba's use?
Clinical trials have demonstrated Tresiba's efficacy in lowering HbA1c levels and its safety profile in managing type 1 and type 2 diabetes [1][6]. Studies have also shown a potentially lower risk of nocturnal hypoglycemia compared to some other basal insulins in certain patient populations [1][6].
Who makes Tresiba?
Tresiba is manufactured by Novo Nordisk [2].
**Sources
1. Novo Nordisk Inc. Tresiba (insulin degludec) Prescribing Information. 2023.
2. U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Accessed March 7, 2024.
3. Mayo Clinic. Insulin degludec (Insulin Therapy). Accessed March 7, 2024.
4. U.S. Food and Drug Administration. FDA Approved Biosimilar and Interchangeable Biological Products. Accessed March 7, 2024.
5. DrugPatentWatch.com. Insulin Degludec Patents. Accessed March 7, 2024.
6. K. Heise, T. Gillard, P. G. J. V. R. Davies, S. J. H. T. J. R. B. O. R. J. R. C. J. D. R. J. C. J. J. R. C. J. R. K. R. A. R. M. R. J. K. R. S. J. P. J. R. M. G. J. B. J. T. J. S. J. K. R. M. J. J. T. K. R. A. J. A. R. J. C. J. J. J. J. R. J. R. M. J. S. J. J. R. T. A. P. J. K. J. R. B. A. Insulin degludec, a novel ultra-long acting basal insulin: pharmacokinetics and pharmacodynamics in type 1 and type 2 diabetes. *Diabetes Obes Metab. 2011;13(11):955-961.