Pharmaceutical Composition Comprising Sumatripan For Treating Migraine

Dr. Reddy's Laboratories Ltd.
Refused App No 201847004353 Pharmaceuticals

Patent information

IP India · live record
Application number
201847004353
Filing date
05 February 2018
Status
Refused
Publication number
06/2018
Publication type
INA
Invention field
Pharmaceuticals

Abstract

The present application relates to a method of treating migraine or cluster headache in a human patient said method comprising administering subcutaneously composition comprising sumatriptan or its pharmaceutically acceptable salt in an amount equivalent to 3 mg sumatriptan base.

Applicants

1
India
DR. REDDY'S LABORATORIES LTD. 8-2-337, Road No.3, Banjara Hills,Hyderabad, Telangana 500034, India

Inventors

5
India
PRABHAKARA, PrabhuHouse #2-59/2,'Padmashree' Jaddu House Athradi, Udupi Karnataka 576107, India
India
PATIL, Rajesh, Ramesh17, Ram Darshan CHS, Chitranjandas Path Ram Nagar, Dombivli, Distthane Maharashtra 421201, India
India
GUPTA, PiyushD-98, Ramprastha Ghaziabad Uttar Pradesh 201011, India
India
RAGHUVANSHI, Rajeev, Singh#605, Ivory Towers South City-I Gurgaon Haryana 122001, India
U.S.A.
NAMBOODIRIPA D, Anil, N.29 Ludlow Road Yardley, Pennsylvania 19067, United States of America

Specification

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an aqueous solution of sumatriptan or its pharmaceutically acceptable salts thereof in an amount equivalent to 3 mg of sumatriptan base, and sodium chloride in an amount to maintain the osmolality of said solution between 275 to 315 mOsm/kg; wherein said sumatriptan and sodium chloride are present in a ratio of from about 0.80:1.00 to about 1.40:1.00; wherein said composition has a pH of about 4.2 to 5.3; wherein said composition is subcutaneoosly administered to the patient at a maximum recommended frequency according to the body mass index (BMI) of the patient; and wherein the subcutaneous administration of said composition to the patient results in a systemic exposure characterized by at least one of the following plasma profiles: c. Cma* of about 35 ng/ml to about 57 ng/ml; d. AUCo-2 of about 30 ng.hr/ml to about 50 ng.hr/ml; a. AUQ).jnf of about 43 ng.hr/ml to about 70 ng.hr/ml. 29. The composition of Claim 28, wherein the maximum recommended frequency of administration is not more than four times a day if the BMI is less than about 26. 30. The composition of Claim 28, wherein the maximum recommended frequency of administration is not more than four times a day if the BMI is greater than or equal to about 26.

Documents

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Orders
Section
Application documents
1 201847004353-STATEMENT OF UNDERTAKING (FORM 3) [05-02-2018(online)].pdf 05 Feb 2018
2 201847004353-POWER OF AUTHORITY [05-02-2018(online)].pdf 05 Feb 2018
3 201847004353-FORM 1 [05-02-2018(online)].pdf 05 Feb 2018
4 201847004353-DECLARATION OF INVENTORSHIP (FORM 5) [05-02-2018(online)].pdf 05 Feb 2018
5 201847004353-COMPLETE SPECIFICATION [05-02-2018(online)].pdf 05 Feb 2018
6 201847004353-FORM 3 [30-05-2018(online)].pdf 30 May 2018
7 201847004353-RELEVANT DOCUMENTS [24-10-2018(online)].pdf 24 Oct 2018
8 201847004353-PETITION UNDER RULE 137 [24-10-2018(online)].pdf 24 Oct 2018
9 Correspondence by Agent_Form 1, Petition Under Rule_29-10-2018.pdf 29 Oct 2018
10 201847004353-FORM 3 [20-03-2019(online)].pdf 20 Mar 2019
11 201847004353-FORM 13 [20-03-2019(online)].pdf 20 Mar 2019
12 201847004353-FORM 18 [26-03-2019(online)].pdf 26 Mar 2019
13 201847004353-FER.pdf 27 Nov 2019
14 201847004353-FORM 3 [16-03-2020(online)].pdf 16 Mar 2020
15 201847004353-FER_SER_REPLY [26-05-2020(online)].pdf 26 May 2020
16 201847004353-COMPLETE SPECIFICATION [26-05-2020(online)].pdf 26 May 2020
17 201847004353-CLAIMS [26-05-2020(online)].pdf 26 May 2020
18 201847004353-ABSTRACT [26-05-2020(online)].pdf 26 May 2020
19 201847004353-US(14)-HearingNotice-(HearingDate-07-10-2022).pdf 07 Sep 2022
Search strategy
1ss_14-11-2019.pdf