Neelam Sharma, MS; Lakshmi Lavanya Kundurthy, BE; and Hemant N. Joshi, Ph.D., MBA* - Tara Innovations, LLC www.tarainnovations.com *hemantjoshi.tara@gmail.com
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in April and May 2025.
Treatment of Demyelinating Disorders;
S. Way, B. Clayton, nd B. Popko; The University of Chicago, U.S.; U.S. Patent #12,310,933; May 27, 2025.
A demyelinating disorder is a condition in which the myelin sheath of a neuronal cell is damaged. This leads to impaired nerve transmission and multiple disorders. There are no known cures for demyelinating disorders. Several of the currently approved treatments have significant side effects. The present patent addresses the limitations of current therapeutics. This invention describes new methods and compositions for treating demyelinating disorders using guanabenz or its derivatives. Guanabenz is a small-molecule α₂-adrenergic agonist known for its neuroprotective potential. The invention proposes that guanabenz and related compounds can treat, delay symptom onset, reduce relapse severity, and protect nerve cells, offering a promising alternative to existing therapies.
Topical Roflumilast Formulation Having Improved Delivery and Plasma Half-Life;
Arcutis Biotherapeutics, U.S.; U.S. Patent #12,310,956; May 27, 2025.
The patent describes the topical rofl umilast formulation. Rofl umilast is used to treat inflammation. The present invention is directed to methods for improving the therapeutic outcome of treatment with rofl umilast. Formulation is designed to get into the skin more efficiently and have a longer plasma half-life. The rofl umilast composition preferably includes dicetyl phosphate, ceteth-10 phosphate, diethylene glycol I monoethyl ether, and/or hexylene glycol.
Drug Delivery Device with Feedback Mechanism;
T. M. Kemp and H. Revellat; Sanofi Aventis Deutschland GmbH, Frankfurt am Main (DE); U.S. Patent #12,303,672; May 20, 2025.
The invention relates to a drug delivery device (such as an autoinjector) that includes a feedback mechanism to confirm full delivery of a medicament. The device has a case that holds the medicament container; a plunger that moves from a proximal to a distal position to push the drug out; a collar and control spring that form part of a feedback system; and a needle shroud that initially couples with the collar and is held in place by the plunger. As the plunger moves to its distal position during injection, it allows the needle shroud to decouple from the collar, enabling limited axial movement. This causes the collar to move and recouple with the shroud in a new position, providing feedback to the user that the full dose has been delivered.
Trim Proteins and Galectins Cooperate and Co-Direct Autophagy and are Useful in the Treatment of Autophagy-Related Diseases.
V. Deretic; UNM Rainforest Innovations, U.S.: U.S. Patent #12,285,470; April 29, 2025.
Autophagy is an orderly degradation and recycling of cellular components. It also plays a key role in the homeostasis of non-starved cells, ensuring their optimal functioning. Macro-autophagy is a type of autophagy where organelles or protein aggregates are engulfed by autophagosomes. Tripartite motif (TRIM) proteins function as a platform for the assembly of autophagy regulators and recognize targets. The patent describes a method of treating Mycobacterium tuberculosis infection and proposes to administer the TRIM 16 protein and at least one galectin. Galectins are a class of proteins that bind specifically to beta-galactoside sugars.
Envenomation Therapies and Related Pharmaceutical Compositions, Systems, and Kits;
M.R. Lewin; Opherix, Inc., U.S.; U.S. Patent #12,274,691; April 15, 2025.
Envenomation is the process of injecting venom through the bites and stings of venomous animals. Venom composition varies tremendously. We see inter- and intra-species variation, and therefore, it is difficult to develop an anti-venom useful to treat all venoms. The patent claimed to treat patients with a PLA1 inhibitor (varespladib or methyl varespladib or their combination) and a metalloproteinase inhibitor. Varespladib acts as an anti-inflammatory agent by disrupting the first step of the arachidonic acid pathway of inflammation. Metalloproteinases can break down connective tissue, resulting in various pathological conditions such as inflammation, metastasis, and angiogenesis.
More Potent and Less Toxic Formulations of Epinephrine and Methods of Medical Use;
D. Rubin; Advanced Respiratory Technologies, U.S.; U.S. Patent #12,290,493; May 6, 2025.
The present invention provides improved injectable liquid pharmaceutical formulations of levorotatory epinephrine (l-epinephrine). These are preservative-free,sul sulfite-free, stabilized against racemization and oxidation, enabling enhanced safety, potency, and shelf-life. The formulations are prepared using l-epinephrine hydrochloride USP, pH adjusted to 2.8–3.3, and compounded with a tonicity agent in aqueous solution under a nitrogen atmosphere to minimize oxygen exposure. The invention further includes sterile delivery formats, such as prefilled syringes and autoinjectors, and novel therapeutic uses, including continuous intravenous infusion for septic shock and safe treatment of anaphylaxis in sulfit-sensitive patients.
Methods of Improving the Solubility and Bioavailability of Therapeutic Agents;
A. K. Jha; MMA Laboratories, Inc., U.S.; U.S. Patent #12,268,786; April 8, 2025.
Improving the oral bioavailability of formulations is always a challenge to formulation scientists. The drug solubility can be a major reason for low bioavailability. In this patent, nanoparticles of the drug substance were produced by milling in a ball mill. The nanoparticles were coated with one or more polymers, where the coating is performed using a melt extrusion process high-temperature milling process. The inventors applied this technology to many drugs, and the bioavailability increased by about 2-fold to about 20-fold.
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