IP Library › Granted Patent US 12,502,385
Granted Patent B2
US 12,502,385 · App. 17/507,037 · Granted Dec 23, 2025

Analogs of deutetrabenazine, their preparation and use

Inventors: Chengzhi Zhang (San Diego, CA); James Kerr (North Wales, PA)
Assignee: AUSPEX PHARMACEUTICALS LLC
A61K31/4745A61K31/473A61P25/14A61P25/28C07D471/04
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Quick Facts
Patent No.
US 12,502,385
App. No.
17/507,037
Granted
Dec 23, 2025
Kind
B2
Abstract

The disclosure is directed to deutetrabenazine analogs, compositions comprising same and methods of detecting same in compositions comprising deutetrabenazine.

Claims (13)

1 . An isolated compound that is:

or a salt or stereoisomer thereof.

2 . A composition comprising the isolated compound of claim 1 , wherein the composition is substantially free of deutetrabenazine.

3 . The composition of claim 2 , wherein the compound is:

or a salt thereof.

4 . The composition of claim 2 , wherein the compound is

or a stereoisomer thereof.

5 . The composition of claim 2 , wherein the compound is

6 . The isolated compound of claim 1 , wherein the compound is

or a salt thereof.

7 . The isolated compound of claim 1 , wherein the compound is

or a stereoisomer thereof.

8 . The isolated compound of claim 1 , wherein the compound is

Assignments (1)
CHANGE OF NAME Recorded Oct 13, 2025
From: AUSPEX PHARMACEUTICALS, INC.
To: AUSPEX PHARMACEUTICALS LLC
Reel/Frame 073081/0526 →
Continuity (4)
Division 16582362 · Sep 25, 2019
Division 15922329 · Mar 15, 2018
Provisional Application 62471484 · Mar 15, 2017
Related Publication 20220040170A1 · Feb 10, 2022
References Cited (24)
US 8524733B2 · Gant et al. · 2013 [cited by applicant]
US 9233959B2 · Sommer et al. · 2016 [cited by applicant]
US 20080167337A1 · Gano · 2008 [cited by applicant]
US 20120003330A1 · Gant et al. · 2012 [cited by applicant]
US 20150152099A1 · Zhang · 2015 [cited by examiner]
US 20160222008A1 · Sommer et al. · 2016 [cited by applicant]
US 20160287574A1 · Stamler et al. · 2016 [cited by applicant]
WO 2010044981A3 · 2010 [cited by applicant]
WO 2011153157A3 · 2012 [cited by applicant]
WO WO2012081031A1 · 2012 [cited by examiner]
WO 2018170214A1 · 2018 [cited by applicant]
FDA Guidance to Industry, “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients,” Sep. 2016 (Year: 2016). [cited by examiner]
Malik et al. “HPLC: An Analytical Technique for Pharmaceutical Validation of Omeprazole,” Journal of Engineering, Computers & Applied Sciences, vol. 2, No. 10, Oct. 2013. (Year: 2013). [cited by examiner]
Rhee et al, “Synthesis of 3H-Labeled Tetrabenazine (TBZ),” Journal of Labelled Compounds and Radiopharmaceuticals, vol. 54. Issue 7, 2011, pp. 367-370. [cited by applicant]
Balaji, et al.; “Development and Validation of a new simple and Stability indicating RP-HPLC Method for the determination of Tetrabenazine and its forced degradation impurities in Bulk Drug and Pharmaceutical Dosage for… [cited by applicant]
Bourezg et al., “Structural elucidation of two photolytic degradation products of tetrabenaine”, Journal of Pharmaceutical and Biomedical Analysis 91, 2014, 138-143. [cited by applicant]
FDA Guidance to Industry, “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”, Sep. 2016. [cited by applicant]
Jankovic et al. “Deutetrabenazine in Tics Associated with Tourette Syndrome,” Tremor Other Hyperkinet. Mov. 2016; 1-8. [cited by applicant]
Kenney et al., Expert Review of Neurotherapeutics 2006, 6(1), 7-17. [cited by applicant]
Malik et al., “HPLC: An Analytical Technique for Pharmaceutical Validation of Omeprazole”, Journal of Engineering, Computers & Applied Sciences, vol. 2, No. 10, Oct. 2013. [cited by applicant]
Savani et al., Neurology 2007, 68(10), 797. [cited by applicant]
Meyer, J.M., |Forgotten but not gone: new developments in the understanding and treatment of tardive dyskinesia, CNS Spectrums, vol. 21, Suppl. S1, pp. 13-24 (Jan. 3, 2017). [cited by applicant]
“Guidelines for Raw Drug Impurities of Pharmaceuticals Containing Novel Active Ingredients,” Yakushin No. 877, Notification from the Director of the Examination Division at the Pharmaceutical Affairs Bureau of the Minis… [cited by applicant]
De Oliveira Melo et al., “Advice on Degradation Products in Pharmaceuticals: A Toxicological Evaluation”, PDA J Pharm Sci Technol., May-Jun. 2014, vol. 68, No. 3, pp. 221-238. [cited by applicant]