Claims for Patent: 11,707,451

Summary for Patent: 11,707,451

Title:	Pharmaceutical composition for modified release
Abstract:	A pharmaceutical composition for modified release comprising (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide or a pharmaceutically acceptable salt thereof, and a carrier for a sustained release pharmaceutical composition, wherein a maximum blood drug concentration (Cmax) when administered in a fasted state is 400 ng/mL or less, is disclosed.
Inventor(s):	Yuuki Takaishi, Soichiro Nakamura, Yutaka Takahashi, Takashi Nishizato, Daisuke Murayama, Emiko Murayama, Kazuhiro Sako
Assignee:	Astellas Pharma Inc
Application Number:	US17/114,890
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,707,451
Patent Claims:	1. A method for treating overactive bladder such that the treating is with a reduced food effect, the method comprising administering orally to a subject in need thereof a tablet comprising 10 mg to 200 mg of (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide in a sustained release formulation, wherein the sustained release formulation further comprises a carrier and provides a continuous drug release for at least 4 hours after oral administration, wherein the sustained release formulation is any one selected from the group consisting of a sustained release hydrogel-forming formulation, a multi-layered formulation consisting of a drug core and a release-controlling layer which are geometrically arranged, a gel formulation in which a plurality of gums are combined, an osmotic pump type formulation a formulation utilizing a swelling polymer, a matrix formulation utilizing a water-soluble polymer, a modified release formulation with a coating membrane, and a matrix formulation utilizing an insoluble polymer, and wherein the reduced food effect is compared to that after oral administration of an immediate release formulation comprising (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide. 2. The method according to claim 1, wherein the tablet comprises 25 mg of (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide. 3. The method according to claim 1, wherein the tablet comprises 50 mg of (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide. 4. The method according to claim 1, wherein the sustained release formulation is a sustained release hydrogel-forming formulation. 5. The method according to claim 2, wherein the sustained release formulation is a sustained release hydrogel-forming formulation. 6. The method according to claim 3, wherein the sustained release formulation is a sustained release hydrogel-forming formulation.