IP Library › Granted Patent US 12,735,401
Granted Patent B2
US 12,735,401 · App. 18/726,464 · Granted Sep 15, 2026

Solid state forms of Danicopan and process thereof

Inventors: Anantha Rajmohan Muthusamy (Sivakasi, IN); Meenakshi Sundaram Somasundaram (Virudu Nagar DT, IN)
Assignee: ASSIA CHEMICAL INDUSTRIES LTD
C07D401/14A61K31/506C07D403/14C07K1/306C07K16/18
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Quick Facts
Patent No.
US 12,735,401
App. No.
18/726,464
Granted
Sep 15, 2026
Kind
B2
Abstract

The present disclosure relates to Danicopan solid state forms, processes for preparation thereof, pharmaceutical compositions thereof, and methods of use thereof.

Claims (15)

1 . A crystalline form of Danicopan, designated form DT2, which is characterized by an XRPD pattern having peaks at 8.5, 12.9, 14.7, 17.0 and 19.6 degrees 2-theta±0.2 degrees 2-theta.

2 . A crystalline form of Danicopan according to claim 1 , which is characterized by an XRPD pattern having peaks at 8.5, 12.9, 14.7, 17.0 and 19.6 degrees 2-theta±0.2 degrees 2-theta, and also having one, two, three or four additional peaks selected from 11.5, 22.0, 22.5 and 30.9 degrees two theta±0.2 degrees two theta; or combinations of these data.

3 . A crystalline form of Danicopan according to claim 1 , which is characterized by an XRPD pattern having peaks at 8.5, 12.9, 14.7, 17.0 and 19.6 degrees two theta±0.2 degrees two theta, and also having one, two, three, four, or optionally five additional peaks selected from 20.9, 22.0, 22.5, 27.0 and 30.9 degrees two theta±0.2 degrees two theta.

4 . A crystalline form of Danicopan according to claim 1 , which is characterized by an X-ray powder diffraction pattern having peaks at 8.5, 11.5, 12.9, 14.7, 17.0, 19.6, 22.0, 22.5 and 30.9 degrees two theta±0.2 degrees two theta.

5 . A crystalline form of Danicopan according to claim 1 , which is characterized by an X-ray powder diffraction pattern having peaks at 8.5, 12.9, 14.7, 17.0, 19.6, 20.9, 22.0, 22.5, 27.0 and 30.9 degrees two theta±0.2 degrees two theta.

6 . A crystalline form of Danicopan according to claim 1 , which is characterized by an X-ray powder diffraction pattern substantially as depicted in FIG. 2 or FIG. 3 .

7 . A crystalline form of Danicopan according to claim 1 , which contains no more than about 20% any other crystalline forms of Danicopan.

8 . A crystalline form of Danicopan according to claim 1 , which contains no more than about 20% of amorphous Danicopan.

9 . A crystalline form of Danicopan according to claim 1 , which is chemically pure.

10 . A pharmaceutical composition comprising a crystalline form of Danicopan according to claim 1 and at least one pharmaceutically acceptable excipient.

11 . A process for preparing a pharmaceutical composition comprising combining a crystalline form of Danicopan according to claim 1 with at least one pharmaceutically acceptable excipient.

12 . A medicament comprising the crystalline form of Danicopan according to claim 1 .

13 . A method of treating paroxysmal nocturnal hemoglobinuria (PNH), other complement mediated diseases, or geographic atrophy in age-related macular degeneration, comprising administering a crystalline form of Danicopan according claim 1 to a patient in need of treatment.

14 . The method of claim 13 , wherein the crystalline form of Danicopan is administered to the patient as an add-on therapy in combination with a component 5 inhibitor.

15 . The method of claim 14 , wherein the component 5 inhibitor is ravulizumab or eculizumab.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 9, 2025
From: TEVA PHARMACEUTICALS INTERNATIONAL GMBH
To: ASSIA CHEMICAL INDUSTRIES LTD.
Reel/Frame 071075/0113 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2025
From: MUTHUSAMY, ANANTHA RAJMOHAN; SOMASUNDARAM, MEENAKSHI SUNDARAM
To: TEVA API INDIA PRIVATE LTD.
Reel/Frame 070072/0813 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2025
From: TEVA API INDIA PRIVATE LTD.
To: TEVA PHARMACEUTICALS INTERNATIONAL GMBH
Reel/Frame 070072/0942 →
Priority Claims (2)
IN 202211009155 · Feb 21, 2022 · national
IN 202211019074 · Mar 30, 2022 · national
Continuity (1)
Related Publication 20250066327A1 · Feb 27, 2025
References Cited (5)
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US 10253053B2 · Wiles et al. · 2019 [cited by applicant]
CN 113801189A · 2021 [cited by applicant]
WO 2020051538A1 · 2020 [cited by applicant]
International Search Report and Written Opinion of the International Searching Authority issued in corresponding application PCT/US2023/013270 mailed May 23, 2023 (8 pages). [cited by applicant]