# US 9,434,703 B2 · Viloxazine compositions

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- Number: US 9,434,703 B2
- Document ID: US9434703B2
- Status: Granted
- Kind: B2
- Application number: 14/577,380
- Filed: 2014-12-19
- Published: 2015-05-07
- Granted: 2016-09-06
- Earliest claimed: 2010-04-12
- Assignees: Supernus Pharmaceuticals, Inc.
- Applicants: Supernus Pharmaceuticals, Inc.
- Inventors: Likan Liang; Padmanabh P. Bhatt; David Dain; Jean-Philippe Taquet; Aleksandr Pechenov; Alexei Tchesnokov; Reynold Mariaux
- Web page: https://patentgrep.com/patent/US9434703B2

## CPC

- C07D 265/30: not condensed with other rings
- A61P 7/12: Antidiuretics, e.g. drugs for diabetes insipidus (ADH A61P5/10)
- A61P 13/00: Drugs for disorders of the urinary system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/24: Antidepressants
- A61P 25/26: Psychostimulants, e.g. nicotine, cocaine
- A61P 25/32: Alcohol-abuse
- C07C 215/08: with only one hydroxy group and one amino group bound to the carbon skeleton
- C07C 217/34: by halogen atoms, by trihalomethyl, nitro or nitroso groups, or by singly-bound oxygen atoms
- C07D 265/32: with oxygen atoms directly attached to ring carbon atoms
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07C: ACYCLIC OR CARBOCYCLIC COMPOUNDS

## Abstract

Provided here are methods of manufacture of viloxazine and its various salts, as well as viloxazine-related compounds, such as novel intermediate reaction products and polymorphs thereof. In particular, the methods provide a substantially pure API of viloxazine HCl while avoiding undesirable impurities. The methods further provide for separating, identifying, and characterizing novel polymorphs of viloxazine. Further provided are methods for synthesis and identification and characterization of novel intermediates of viloxazine, as well as for some important metabolites and precursors of metabolites of viloxazine.

## Claims

### Claim 1

A compound having the Formula 4 or Formula 5:

### Claim 2

A composition comprising a compound having Formula 4 or Formula 5:

### Claim 3 (depends on 2)

The composition according to claim 2, wherein the compound having Formula 4 or Formula 5 is present in an amount less than about 2.5 ppm.

### Claim 4 (depends on 2)

The composition according to claim 2, further comprising viloxazine having the Formula 1 or Formula 2 or a pharmaceutically acceptable salt thereof:

### Claim 5 (depends on 3)

The composition according to claim 3, further comprising viloxazine having the Formula 1 or Formula 2 or a pharmaceutically acceptable salt thereof: