PATENT CLAIM ANALYSIS

Application Number: 16150977
Application Type: Utility
Filing Date: 2018-10
Publication Date: 2019-01
Patent Classification: ["546", "184000"]

Abstract:
This invention provides an isolated compound having the structure: or a salt thereof. The invention also provides for a process for preparing 4-(3-(methylsulfonyl)phenyl)-1-propylpiperidin-4-ol, 1-(3,3-bis(3-(methylsulfonyl)phenyl)propyl)-4-(3-(methylsulfonyl) phenyl)piperidone, 1,4-bis((3-(1-propylpiperidin-4-yl)phenyl)sulfonyl)butane, (3R,4S)-4-(3-(methylsulfonyl)phenyl)-1-propylpiperidin-3-ol, 4-(3-(methylsulfonyl)phenyl)-1-propylpiperidine 1-oxide, 1-(2-methylpentyl)-4-(3-(methylsulfonyl)phenyl)piperidine, 4-(3-(methylsulfinyl)phenyl)-1-propyl-1,2,3,6-tetrahydropyridine, and 4-(3-(methylsulfonyl)phenyl)-1-propyl-1,2,3,6-tetrahydropyridine. This invention also provides an impurity or a salt thereof for use, as a reference standard to detect trace amounts of the impurity in a pharmaceutical composition comprising pridopidine or a pharmaceutically acceptable salt thereof. This invention further provides a process for producing a pridopidine drug product comprising obtaining a pridopidine drug substance and. mixing the pridopidine drug substance with suitable excipients so as to produce the pridopidine drug product. This invention also provides a process for producing a pridopidine drug product. This invention also provides a process of distributing a pridopidine drug product.

Claim (Index 93):
A method of determining the concentration of an impurity in a pharmaceutical composition comprising pridopidine and a pharmaceutically acceptable carrier, the method comprising,\n a) preparing a sample solution from the pharmaceutical composition, b) preparing a diluent solution comprising methanol and water, c) preparing a standard solution comprising pridopidine and the diluent solution, d) preparing a resolution solution comprising pridopidine and the impurity, e) preparing a buffer solution by dissolving ammonium formate in water and adjusting to pH of 9.0\u00b10.10 with aqueous ammonia hydroxide or formic acid, f) injecting into the HPLC the diluent solution, the resolution solution, the standard solution, and the sample solution, g) running the HPLC using ultraviolet absorption at 190-400 nm or 268 nm and a mixture of the buffer solution, methanol and water as the mobile phase, h) determining the retention time (RT) and the areas of the peaks of the impurity in the chromatograms of the sample solution, and i) performing quantitation of the impurity with respect to the corresponding peaks in the chromatograms of the sample solution, wherein the impurity is Compound 1, Compound 2, Compound 3, Compound 4, Compound 5 or Compound 6.

Metadata:
- Claim Count in Document: 63.0
- Percentile: 97.0
- Lexical Diversity: 3.0
- Patent Class: 546.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['14754339', '15217683', '13888709', '13708816', '14613845']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7259131511951529
- 35 USC 102 Novelty (BERT): 0.5927526594609671
- Combined Prediction Score: 0.7125971020217343
- Mean Citation Score: 301.388972
- Max Citation Score: 584.1418
- Similarity Product: 415.8497093472957

Labels:
- Claim Label 101: 1
- Claim Label 102: 1
- Claim Label 103: 1
- Claim Label 112: 1
- Combined Label: 1
- Label 101 Adjusted: 1

Dataset: test