# US 2024/0189286 A1 · Viral inhibitors, the synthesis thereof, and intermediates thereto

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- Number: US 2024/0189286 A1
- Document ID: US20240189286A1
- Status: Published application
- Kind: A1
- Application number: 18/400,344
- Filed: 2023-12-29
- Published: 2024-06-13
- Earliest claimed: 2022-10-12
- Assignees: Takeda Pharmaceutical Company Limited
- Applicants: Takeda Pharmaceutical Company Limited
- Inventors: Jeffrey Scott DePue; Suresh Kumar Tipparaju; Helge Alfred Reisch; Datong Tang; Kishore Ramachandran
- Web page: https://patentgrep.com/patent/US20240189286A1

## CPC

- A61K 31/4184: condensed with carbocyclic rings, e.g. benzimidazoles
- A61P 31/22: for herpes viruses
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/7056: containing five-membered rings with nitrogen as a ring hetero atom
- C07H 1/00: Processes for the preparation of sugar derivatives
- C07H 19/04: Heterocyclic radicals containing only nitrogen atoms as ring hetero atom
- C07H 19/052: Imidazole radicals
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07H: SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS (derivatives of aldonic or saccharic acids C07C, C07D; aldonic acids, saccharic acids C07C59/105, C07C59/285; cyanohydrins C07C255/16; glycals C07D; compounds of unknown constitution C07G; polysaccharides, derivatives thereof C08B; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification C12N15/00; sugar industry C13)

## Abstract

The present disclosure discloses compositions comprising maribavir, methods of providing the same, and compositions providing intermediates useful in providing maribavir.

## Claims

### Claim 1

A method of treating a patient with post-transplant cytomegalovirus (CMV) infection and/or disease, the method comprising:
administering to the patient a pharmaceutical composition comprising maribavir, or a pharmaceutically acceptable salt thereof, in an amount of about 400 mg orally twice daily,
wherein the patient is a transplant recipient, wherein the CMV infection and/or disease is refractory to treatment with ganciclovir, valganciclovir, cidofovir or foscarnet,
wherein the pharmaceutical composition comprises:
(i) maribavir:
or a pharmaceutically acceptable salt thereof; and
(ii) one or more of the following, relative to maribavir:
about 0.01% to about 0.1% w/w of Compound 2,
or a pharmaceutically acceptable salt thereof;
about 0.01% to about 0.1% w/w of Compound 3,
or a pharmaceutically acceptable salt thereof; or
about 0.01% to about 0.1% w/w of Compound 4:
or a pharmaceutically accept salt thereof.

### Claim 2

(canceled)

### Claim 3 (depends on 1)

The method according to claim 1, wherein the patient has undergone a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).

### Claim at position 4

4-24. (canceled)

### Claim 25 (depends on 1)

The method according to claim 1, wherein maribavir is crystal Form VI having a particle size distribution (PSD) of d(50) less than about 400 μm.

### Claim 26 (depends on 1)

The method according to claim 1, wherein maribavir is crystal Form VI having a particle size distribution (PSD) of d(50) between about 170 and about 350 μm.

### Claim 27 (depends on 1)

The method according to claim 1, wherein maribavir is crystal Form VI having a particle size distribution (PSD) of d(50) between about 170 and about 226 μm.

### Claim 28 (depends on 1)

The method according to claim 1, wherein maribavir is crystal Form VI having a particle size distribution (PSD) of d(50) between about 227 and about 280 μm.

### Claim 29 (depends on 1)

The method according to claim 1, wherein maribavir is crystal Form VI having a particle size distribution (PSD) of d(50) between about 281 and about 336 μm.

### Claim 30 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition further comprises about 0.01% to about 0.5% w/w of D-maribavir,
or a pharmaceutically acceptable salt thereof.

### Claim 31 (depends on 30)

The method according to claim 30, wherein the pharmaceutical composition further comprises less than 0.1% of D-maribavir, or a pharmaceutically acceptable salt thereof.

### Claim 32 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition comprises about 0.1%, about 0.05%, about 0.02%, or about 0.01% (w/w HPLC) of compound 4, relative to maribavir.

### Claim 33 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition comprises about 0.1% (w/w HPLC) of compound 4, relative to maribavir.

### Claim 34 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition comprises about 0.05 (w/w HPLC) of compound 4, relative to maribavir.

### Claim 35 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition comprises about 0.02% (w/w HPLC) of compound 4, relative to maribavir.

### Claim 36 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition comprises about 0.01% (w/w HPLC) of compound 4, relative to maribavir.