See the DrugPatentWatch profile for Lanreotide
What Is Lanreotide API?
Lanreotide is a synthetic somatostatin analogue used mainly for acromegaly and neuroendocrine tumours. The API (active pharmaceutical ingredient) is a 30‑amino‑acid peptide that mimics natural somatostatin, binding to five somatostatin receptor subtypes and inhibiting hormone secretion. The molecule contains several non‑natural amino acids (e.g., β‑Ala, D‑Ala) that increase stability and half‑life compared with endogenous somatostatin.
How Is Lanreotide Made in the Lab?
The peptide is assembled via solid‑phase peptide synthesis (SPPS). Each residue is added one at a time on a resin support, with protection groups removed between steps. After the full chain is built, the peptide is cleaved from the resin, purified by reverse‑phase HPLC, and formulated into a sterile, buffered solution for injection. Because of the sequence’s length and the need for precise stereochemistry, the synthesis process is costly and requires strict quality control.
Who Holds the Key Patents on Lanreotide?
The original patents covering lanreotide and its formulation were filed by Ipsen in the 1990s. The main claims cover the peptide sequence, the method of synthesis, and the drug product for treating acromegaly and neuroendocrine tumours. DrugPatentWatch lists several active patents and pending applications in the US, EU, and other regions [1].
When Do Lanreotide Patents End?
Most of the core patents on lanreotide’s peptide sequence and use are set to expire between 2025 and 2030, depending on jurisdiction. However, secondary patents on specific manufacturing processes, formulations, or delivery devices may extend exclusivity for a few additional years.
Can Biosimilars Enter the Market Now?
Because the core patents are still active, any company looking to launch a biosimilar would face patent litigation or need to license the technology. Some competitors have started filing for biosimilar approvals, but they will likely have to wait until the primary patents lapse or negotiate licenses.
Is Lanreotide API Covered by Exclusive Manufacturing Rights?
The patents granted to Ipsen (and its licensees) cover the manufacturing process and the API itself. In most countries, the manufacturer of the commercial product holds an exclusive right to produce the same or an equivalent peptide, so generic manufacturers cannot produce or sell the API without infringing.
Where Can You Get Reliable Lanreotide API Supplies?
Licensed manufacturers in the US, Europe, and Asia supply the API under strict GMP conditions. Companies such as Ipsen and its subsidiaries, as well as certain contract manufacturers, are authorized distributors. Unlicensed sources are scarce because of the high risk of patent infringement.
How Does Lanreotide API Compare to Similar Peptide Drugs?
Lanreotide’s API is structurally similar to octreotide and pasireotide but differs in amino‑acid substitutions that extend half‑life and broaden receptor affinity. These differences translate into dosing intervals of 4–6 weeks for lanreotide, versus monthly for octreotide, and a distinct side‑effect profile.
Sources
1. DrugPatentWatch.com – Lanreotide patents and filing details. https://www.drugpatentwatch.com/ [1]