Endo International has filed a patent for synthesizing pure varenicline and its intermediates, as well as a pharmaceutical composition for smoking cessation. The patent claims a tablet form of the composition with specific limits on impurity levels. GlobalData’s report on Endo International gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Endo International, was a key innovation area identified from patents. Endo International's grant share as of September 2023 was 64%. Grant share is based on the ratio of number of grants to total number of patents.

The patent is filed for a pharmaceutical composition for smoking cessation

Source: United States Patent and Trademark Office (USPTO). Credit: Endo International Plc

A recently filed patent (Publication Number: US20230285406A1) describes a pharmaceutical composition in the form of a tablet that contains varenicline tartrate. The tablet is formulated to have less than 50 ppm of N-nitroso-varenicline impurity and less than 0.15% (w/w) of diamide impurity. These impurities are measured using specific methods recommended by the U.S. FDA.

The composition can also include various excipients such as maltodextrin, microcrystalline cellulose, sodium citrate, calcium carbonate, and others. The tablet typically contains between 0.85 mg and 1.7 mg of varenicline tartrate and has less than 25 ppm of N-nitroso-varenicline impurity per tablet.

The patent also mentions additional impurities that should be present in the tablet in very low amounts. These impurities include monomethyl tartrate, dimethyl tartrate, N-methyl varenicline, N-formyl varenicline, varenicline N-glucoside, dinitro nitrosoamine, and diamino nitrosoamine. The tablet should contain less than 0.15% (w/w) of each of these impurities.

Another embodiment of the invention involves a tablet containing varenicline free base and tartaric acid as a counterion. This tablet should also have less than 50 ppm of N-nitroso-varenicline impurity and less than 0.15% (w/w) of diamide impurity.

Overall, this patent describes a pharmaceutical composition in tablet form that contains varenicline tartrate or varenicline free base with specific limits on impurities. The composition may also include various excipients. The patent emphasizes the importance of maintaining low levels of impurities to ensure the quality and safety of the tablet.

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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