Glenmark Pharmaceuticals has filed a patent for a crystalline form of a compound that has retinoid-related orphan receptor gamma (RORy) modulator activity. The patent also covers processes for preparing the compound, pharmaceutical compositions containing it, and its use in therapy. GlobalData’s report on Glenmark Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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Data Insights Glenmark Pharmaceuticals Ltd - Company Profile

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According to GlobalData’s company profile on Glenmark Pharmaceuticals, Nanoparticle drug conjugates was a key innovation area identified from patents. Glenmark Pharmaceuticals's grant share as of September 2023 was 28%. Grant share is based on the ratio of number of grants to total number of patents.

Crystalline form of a compound for therapy

Source: United States Patent and Trademark Office (USPTO). Credit: Glenmark Pharmaceuticals Ltd

A recently filed patent (Publication Number: US20230312486A1) describes a crystalline form of a compound represented by formula (I). The compound, (S)-2-(4-(1,1-difluoro-2-hydroxypropyl)phenyl)-N-(4-(3-(2-ethylphenyl) pyrazin-2-yl)phenyl) acetamide, is claimed to exist in a crystalline form with a specific X-ray diffraction pattern. The characteristic peaks of this crystalline form are expressed in terms of 2? ±0.2 and include values such as 11.22, 12.01, 15.88, 18.06, 19.28, and 19.97.

The patent also claims that the crystalline compound of formula (I) has an average particle size value (D50) ranging from about 1 µm to about 20 µm. Additionally, the compound is said to have a purity greater than 99% by HPLC and is in a substantially pure crystalline form.

The patent further discloses a process for preparing the crystalline form of the compound. The process involves treating the compound with a solvent, heating the reaction mass to obtain a clear solution, gradually cooling it, and isolating the resulting solid. The solvent used in the process can be selected from a group of options including acetonitrile, ethyl acetate, methanol, ethanol, isopropanol, acetone, methyl acetate, acetic acid, ethylene glycol, and 1,4-dioxane.

Another process for preparing the crystalline form involves treating the compound with a solvent to obtain a clear solution, adding an anti-solvent, and isolating the solid. The solvent options for this process include acetonitrile, methanol, acetone, THF, toluene, methyl ethyl ketone, and ethyl acetate. The anti-solvent options include diisopropyl ether, hexane, methyl tert. butyl ether, and methanol.

Additionally, the patent describes a process for preparing the amorphous form of the compound. This process involves heating the compound to melt under vacuum and then cooling the resulting product.

Overall, the patent presents a crystalline form of a compound represented by formula (I) and provides detailed processes for preparing both the crystalline and amorphous forms of the compound. The patent claims specific characteristics of the crystalline form, such as its X-ray diffraction pattern and particle size, as well as its high purity.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies