Process for Manufacturing Pibrentasvir Active Drug Substance
AssigneeAbbVie Inc.
InventorsMichael Hillier, Chirag Gheewala, Riley Hastings
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Abstract
The present invention relates to compositions of pibrentasvir, drug products thereof, and processes and intermediates for the preparation thereof. This invention relates to the drug product, active drug substance, intermediates, and processes of pibrentasvir, a NS5A inhibitor that is useful in the treatment of hepatitis C.
Claims29
A compound of formula (IIa):
A process for preparing (1S,4S)-1,4-bis(4-chloro-2-fluoro-5-nitrophenyl)butane-1,4-diol (I) comprising:
- separating Compound (IIa),
- from Compound (I),
A process for preparing pibrentasvir in substantially pure form comprising, separating Compound (IIa),
- from Compound (I)
A composition comprising pibrentasvir;
- and
- an impurity;
- wherein the composition comprises at least 97 weight percent of pibrentasvir and not more than 3 weight percent of the impurity;
- wherein the composition is prepared by a process comprising,
- separating Compound (IIa),
- from Compound (I)
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)
Dependencies are inferred from the claim text.