PATENT CLAIM ANALYSIS

Application Number: 16301769
Application Type: Utility
Filing Date: 2018-11
Publication Date: 2019-05
Patent Classification: ["548", "304400"]

Abstract:
Provided is a purifying method for dabigatran etexilate free base, comprising subjecting a dabigatran etexilate free base crude product to water slurrying to obtain a crude product B; then conducting recrystallization on the crude product B with acetone and water to obtain a crude product C; and subsequently, purifying the crude product C with a mixed solvent of tetrahydrofuran and ethyl acetate, filtering and drying to obtain a dabigatran etexilate free base finished product. The purifying method of the present invention can effectively remove various impurities and is suitable for workshop production. Salts and water-soluble organic impurities are removed by purified water slurrying, impurities with a high polarity are removed by purifying with an acetone-water solution, and impurities with a low polarity are removed by purifying with a mixed solvent of tetrahydrofuran and ethyl acetate.

Claim (Index 7):
A pharmaceutical composition, comprising dabigatran etexilate with content no less than 99.8%, an alcoholysis impurity of formula-I with content no more than 0.05%, and a methyl ester impurity of formula-II with content no more than 0.05%, wherein all of the content is determined by HPLC area normalization method:

Metadata:
- Claim Count in Document: 17.0
- Percentile: 98.0
- Lexical Diversity: 2.23077
- Patent Class: 548.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['14779911', '13995786', '14394409', '15291087', '11813211']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7458160135927911
- 35 USC 102 Novelty (BERT): 0.4979097836422446
- Combined Prediction Score: 0.7210253905977365
- Mean Citation Score: 243.474942
- Max Citation Score: 252.99785
- Similarity Product: 183.2755139830828

Labels:
- Claim Label 101: 1
- Claim Label 102: 1
- Claim Label 103: 0
- Claim Label 112: 1
- Combined Label: 1
- Label 101 Adjusted: 1

Dataset: test