IP Library Granted Patent US 11,083,724
Granted Patent B2
US 11,083,724 · App. 16/884,196 · Granted Aug 10, 2021

Rimegepant for CGRP related disorders

Inventors: Vladimir Coric (Madison, CT); Robert Croop (Newton Square, PA)
Assignee: Biohaven Pharmaceutical Ireland DAC
A61K31/4709A61K9/2018A61K9/2063A61K31/4545A61P25/06
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Quick Facts
Patent No.
US 11,083,724
App. No.
16/884,196
Granted
Aug 10, 2021
Kind
B2
Abstract

Disclosed are methods of treating CGRP related disorders, e.g., migraine, by administering to a patient in need thereof rimegepant or a pharmaceutically acceptable salt thereof. Pharmaceutical compositions comprising rimegepant and kits including the pharmaceutical compositions and instructions are also disclosed.

Claims (20)

1. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a CGRP receptor antagonist, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form.

2. The pharmaceutical composition of claim 1 , wherein the CGRP receptor antagonist is selected from olcegepant, telcagepant, ubrogepant, atogepant, and rimegepant.

3. The pharmaceutical composition of claim 1 , further comprising gelatin as a carrier.

4. The pharmaceutical composition of claim 1 , further comprising mannitol as a filler.

5. The pharmaceutical composition of claim 1 , comprising from about 70-80 weight % of the CGRP antagonist, about 10-20 weight % fish gelatin, about 10-20 weight % of a filler, and 0.1-5.0 weight % of a flavorant.

6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is capable of disintegrating or dispersing within an interval selected from 1 to 60 seconds, 1 to 30 seconds, 1 to 10 seconds, and 2 to 8 seconds, after being placed in contact with a fluid.

7. The pharmaceutical composition of claim 6 , wherein the fluid comprises saliva.

8. A method of treating migraine in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of a CGRP receptor antagonist, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form.

9. The method of claim 8 , wherein the CGRP receptor antagonist is selected from olcegepant, telcagepant, ubrogepant, atogepant, and rimegepant.

10. The method of claim 8 , comprising from about 70-80 weight % of the CGRP antagonist, about 10-20 weight % fish gelatin, about 10-20 weight % of a filler, and 0.1-5.0 weight % of a flavorant.

11. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of rimegepant, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is in a form of an oral solid molded fast-dispersing dosage form.

12. The pharmaceutical composition of claim 11 , comprising about 75 mg of rimegepant or a pharmaceutically acceptable salt thereof.

13. The pharmaceutical composition of claim 11 , wherein the rimegepant is in the form of a hemisulfate sesquihydrate salt.

14. The pharmaceutical composition of claim 11 in the form of a tablet.

15. The pharmaceutical composition of claim 11 , that provides an AUC 0-t of from about 80-125% of 5000 (hr*ng/mL).

16. The pharmaceutical composition of claim 11 , comprising from about 70-80 wt % rimegepant hemisulfate sesquihydrate, about 10-20 wt % fish gelatin, about 10-20 wt % of a filler, and 0.1-5.0 wt % of a flavorant.

17. The pharmaceutical composition of claim 11 , further comprising gelatin as a carrier.

18. The pharmaceutical composition of claim 11 , further comprising mannitol as a filler.

19. The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition is capable of disintegrating or dispersing within an interval selected from 1 to 60 seconds, 1 to 30 seconds, 1 to 10 seconds, and 2 to 8 seconds, after being placed in contact with a fluid.

20. The pharmaceutical composition of claim 19 , wherein the fluid comprises saliva.

Assignments (4)
CHANGE OF NAME Recorded Jan 22, 2025
From: PFIZER IRELAND PHARMACEUTICALS
To: PFIZER IRELAND PHARMACEUTICALS UNLIMITED COMPANY
Reel/Frame 069987/0162 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2023
From: BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD
To: PFIZER IRELAND PHARMACEUTICALS
Reel/Frame 063269/0373 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 7, 2022
From: BIOHAVEN PHARMACEUTICAL IRELAND DESIGNATED ACTIVITY COMPANY
To: PFIZER IRELAND PHARMACEUTICALS
Reel/Frame 061885/0685 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2020
From: BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
To: BIOHAVEN PHARMACEUTICAL IRELAND DAC
Reel/Frame 053404/0483 →