PATENT CLAIM ANALYSIS

Application Number: 16049390
Application Type: Utility
Filing Date: 2018-07
Publication Date: 2018-11
Patent Classification: ["424", "464000"]

Abstract:
The invention pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone which produces a mean minimum blood plasma level 12 to 24 hours after dosing, as well as the tablet producing the sustained pain relief.

Claim (Index 1):
A solid oral controlled release dosage form, comprising:\n (a) about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and (b) a controlled release matrix, comprising:\n (i) about 10% to about 75% (by total weight of the controlled release matrix) of a gelling agent which forms a gel upon exposure to gastrointestinal fluid; and \n (ii) a filler; \n wherein upon placement of the dosage form in an in vitro release rate test, about 27% to about 33%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 1 hour in the test, about 40% to about 48%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 2 hours in the test, about 50% to about 59%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 3 hours in the test, about 58% to about 67%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 4 hours in the test, about 64% to about 74%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 5 hours in the test, about 70% to about 84%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 6 hours in the test, about 79% to about 92%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 8 hours in the test, and at least 85%, by weight, of the oxymorphone or salt thereof is released from the dosage form at about 10 hours in the test; wherein upon oral administration of the dosage form to a human subject in need of an analgesic effect, the blood plasma concentration of oxymorphone comprises a first peak at about 3 hours after administration and a second peak at about 6-7 hours after administration; and wherein upon oral administration of the dosage form to the subject:\n (i) the dosage form provides detectable blood plasma levels of 6-OH oxymorphone and oxymorphone; \n (ii) the blood plasma levels of 6-OH oxymorphone and oxymorphone peak within about 1 hour to about 8 hours after administration; \n (iii) the blood plasma levels of 6-OH oxymorphone and oxymorphone exhibit a ratio of area under the curve (AUC (0 to inf) ) of blood plasma level versus time for 6-OH oxymorphone compared to oxymorphone in a range of about 0.5 to about 1.5; and \n (iv) the duration of the analgesic effect is through at least about 12 hours after administration.

Metadata:
- Claim Count in Document: 50.0
- Percentile: 95.0
- Lexical Diversity: 1.18919
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['11427438', '10190192', '11680432', '12716973', '14336753']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7768282011321572
- 35 USC 102 Novelty (BERT): 0.5848528084262702
- Combined Prediction Score: 0.7576306618615686
- Mean Citation Score: 463.99081000000007
- Max Citation Score: 525.475
- Similarity Product: 400.8157812178137

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