IP Library Granted Patent US 8,802,854
Granted Patent B2
US 8,802,854 · App. 13/639,453 · Granted Aug 12, 2014

Crystalline forms of Prasugrel salts

Inventors: Mihaela Tuksar (Cakovec, HR); Tomislav Biljan (Krizevci, HR); Miroslav Zegarac (Zagreb, HR)
Assignee: Teva Pharmaceutical Industries Ltd.
C07D495/04
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Quick Facts
Patent No.
US 8,802,854
App. No.
13/639,453
Granted
Aug 12, 2014
Kind
B2
Abstract

Salts of prasugrel were prepared including, for example, crystalline forms of prasugrel hydrobromide. These salts are useful, for example, in medicaments that inhibit the aggregation of platelets.

Claims (14)

1. A crystalline Form I of Prasugrel hydrobromide according to formula I,

characterized by:

an X-ray powder diffraction pattern having peaks at 7.8, 14.4, 16.9, 22.0 and 25.1 degrees two theta±0.2 degrees two theta;

a solid-state 13 C NMR spectrum having peaks at 7.1, 11.2, 63.6, 123.7 and 203.4±0.2 ppm; or a combination thereof.

2. A crystalline Form IA of Prasugrel hydrobromide according to formula I,

characterized by an X-ray powder diffraction pattern having peaks at 7.9, 8.1, 13.5, 14.6 and 25.2 degrees two theta±0.2 degrees two theta.

3. The crystalline Form I of Prasugrel hydrobromide according to claim 1 , further characterized by an XRPD pattern substantially as depicted in FIG. 6 and/or by a solid-state 13C NMR spectrum substantially as depicted in FIG. 23 .

4. The crystalline Form IA of Prasugrel hydrobromide according to claim 2 , further characterized by an XRPD pattern substantially as depicted in FIG. 11 .

5. A pharmaceutical composition comprising at least one crystalline form according to any of claims 1 , 2 and 3 - 4 , and at least one pharmaceutically acceptable excipient.

6. A method of producing a pharmaceutical composition comprising combining at least one crystalline form according to any of claims 1 , 2 and 3 - 4 , and at least one pharmaceutically acceptable excipient.

7. The crystalline Form I of Prasugrel hydrobromide according to claim 1 , wherein the crystalline Form I is anhydrous.

8. The crystalline Form IA of Prasugrel hydrobromide according to claim 2 , wherein the crystalline Form IA is anhydrous.

9. The crystalline Form I of Prasugrel hydrobromide according to claim 1 wherein the X-ray powder diffraction pattern has additional peaks at 13.5, 19.9, 23.6, 27.0 and 29.7 degrees two theta±0.2 degrees two theta.

10. The crystalline Form IA of Prasugrel hydrobromide according to claim 2 wherein the X-ray powder diffraction pattern has additional peaks at 16.8, 21.4, 23.7, 24.9 and 27.2 degrees two theta±0.2 degrees two theta.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 9, 2025
From: TEVA PHARMACEUTICAL INDUSTRIES LTD.
To: ASSIA CHEMICAL INDUSTRIES LTD.
Reel/Frame 071073/0319 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 8, 2013
From: TUKSAR, MIHAELA; BILJAN, TOMISLAV; ZEGARAC, MIROSLAV
To: TEVA PHARMACEUTICAL INDUSTRIES LTD.; TEVA PHARMACEUTICALS USA, INC.
Reel/Frame 029586/0374 →
Continuity (5)
Provisional Application 61322165 · Apr 8, 2010
Provisional Application 61326882 · Apr 22, 2010
Provisional Application 61348914 · May 27, 2010
Provisional Application 61355304 · Jun 16, 2010
Related Publication 20130085154A1 · Apr 4, 2013