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US 2025/0051312 A1Published application
Process for Manufacturing Pibrentasvir Active Drug Substance
AssigneeAbbVie Inc.
InventorsMichael Hillier, Chirag Gheewala, Riley Hastings
Life of this patent
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Abstract
The present invention relates to compositions of pibrentasvir, drug products thereof, and processes and intermediates for the preparation thereof.
Claims25
A compound of formula (IIa):
(canceled)
A process for preparing (15,4S)-1,4-bis (4-chloro-2-fluoro-5-nitrophenyl)butane-1,4-diol (I) comprising:
- separating Compound (IIa),
- from Compound (I),
(canceled)
A process for preparing pibrentasvir in substantially pure form comprising, separating Compound (IIa),
- from Compound (I)
(canceled)
18-22. (canceled)
A drug product comprising a drug substance;
- wherein the drug substance comprises at least 97 weight percent of pibrentasvir and not more than 3 weight percent of an impurity;
- wherein the drug substance is prepared by a process comprising, separating Compound (IIa),
- from Compound (I)
(canceled)
Dependencies are inferred from the claim text.