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Pharmaceutical Composition Comprising Sumatripan For Treating Migraine

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.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
05 February 2018
Publication Number
06/2018
Publication Type
INA
Invention Field
PHARMACEUTICALS
Status
Email
Parent Application

Applicants

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

Inventors

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

Specification

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

Application Documents

# Name Date
1 201847004353-STATEMENT OF UNDERTAKING (FORM 3) [05-02-2018(online)].pdf 2018-02-05
2 201847004353-POWER OF AUTHORITY [05-02-2018(online)].pdf 2018-02-05
3 201847004353-FORM 1 [05-02-2018(online)].pdf 2018-02-05
4 201847004353-DECLARATION OF INVENTORSHIP (FORM 5) [05-02-2018(online)].pdf 2018-02-05
5 201847004353-COMPLETE SPECIFICATION [05-02-2018(online)].pdf 2018-02-05
6 201847004353-FORM 3 [30-05-2018(online)].pdf 2018-05-30
7 201847004353-RELEVANT DOCUMENTS [24-10-2018(online)].pdf 2018-10-24
8 201847004353-PETITION UNDER RULE 137 [24-10-2018(online)].pdf 2018-10-24
9 Correspondence by Agent_Form 1, Petition Under Rule_29-10-2018.pdf 2018-10-29
10 201847004353-FORM 3 [20-03-2019(online)].pdf 2019-03-20
11 201847004353-FORM 13 [20-03-2019(online)].pdf 2019-03-20
12 201847004353-FORM 18 [26-03-2019(online)].pdf 2019-03-26
13 201847004353-FER.pdf 2019-11-27
14 201847004353-FORM 3 [16-03-2020(online)].pdf 2020-03-16
15 201847004353-FER_SER_REPLY [26-05-2020(online)].pdf 2020-05-26
16 201847004353-COMPLETE SPECIFICATION [26-05-2020(online)].pdf 2020-05-26
17 201847004353-CLAIMS [26-05-2020(online)].pdf 2020-05-26
18 201847004353-ABSTRACT [26-05-2020(online)].pdf 2020-05-26
19 201847004353-US(14)-HearingNotice-(HearingDate-07-10-2022).pdf 2022-09-07

Search Strategy

1 ss_14-11-2019.pdf