DrugPatentWatch Database Preview

Sumatriptan succinate - Generic Drug Details

« Back to Dashboard

What are the generic sources for sumatriptan succinate and what is the scope of sumatriptan succinate freedom to operate?

Sumatriptan succinate is the generic ingredient in eight branded drugs marketed by Meridian Medcl, Glaxosmithkline, Antares Pharma Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Injectalia, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Sun Pharma Global, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Endo Ventures Ltd, Avanir Pharms, Dr Reddys Labs Ltd, Teva Branded Pharm, Apotex Inc, Aurobindo Pharma, Fosun Pharma, Hikma Pharms, Mylan, Orchid Hlthcare, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-nine NDAs. There are thirty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan succinate has three hundred and seventy-six patent family members in thirty countries.

There are twenty-four drug master file entries for sumatriptan succinate. Forty-five suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for sumatriptan succinate

International Patents:	376
US Patents:	33
Tradenames:	8
Applicants:	33
NDAs:	39
Drug Master File Entries:	24
Suppliers / Packagers:	45
Bulk Api Vendors:	78
Clinical Trials:	252
Patent Applications:	1,837
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	sumatriptan succinate at DailyMed

Pharmacology for sumatriptan succinate

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Synonyms for sumatriptan succinate

1-(3-(2-(Dimethylamino)ethyl)-1H-indol-5-yl)-N-methylmethanesulfonamide succinate

1-(3-(2-dimethylaminoethyl)-1h-indol-5-yl)-n-methyl-methanesulfonamide succinate

1-[3-(2-DIMETHYLAMINOETHYL)-1H-INDOL-5-YL]-N-METHYL-METHANESULFONAMIDE SUCCINATE

1-[3-(2-dimethylaminoethyl)-1h-indol-5-yl]-n-methylmethanesulfonamide succinate

1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methyl-methanesulfonamide; succinic acid

1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide butanedioate

1-{3-[2-(dimethylamino)ethyl]-1h-indol-5-yl}-n-methylmethanesulfonamide succinate

1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide; butanedioic acid

103628-46-2 (Parent)

103628-48-4

1H-Indole-5-methanesulfonamide, 3-(2-(dimethylamino)ethyl)-N-methyl-, butanedioate (1:1)

3-?[2-?(DIMETHYLAMINO)ETHYL]-?N-?METHYL-?1H-?INDOLE-?5-?METHANESULFONAMIDE-?BUTANEDIOIC ACID

3-(2-(Dimethylamino)ethyl)-N-methylindole-5-methanesulfonamide succinate

3-(2-(Dimethylamino)ethyl)-N-methylindole-5-methanesulfonamide succinate (1:1)

3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl-N-methylmethanesulfonamide Succinate

3-[2-(DIMETHYLAMINO)ETHYL]-N-METHYL-1H-INDOLE-5-METHANESULFONAMIDE SUCCINATE

3-[2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide,butanedioate(1:1)

628S484

A800771

AB0013192

AB07670

AB2000103

AC-751

AC1L1RX2

AC1Q5VRF

AK-56079

AKOS015900409

Alsuma

Alsuma (TN)

AN-1097

Antibet

API0009779

Arcoiran

AX8017360

BC208270

BG0326

Butanedioic acid, compd. with 3-(2-(dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide (1:1)

BUTANEDIOIC ACID, COMPOUND WITH 3-[2-(DIMETHYLAMINO)ETHYL]-N-METHYL-1H-INDOLE-5-METHANESULFONAMIDE (1:1)

butanedioic acid; 1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]-N-methylmethanesulfonamide

butanedioic acid; 1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methyl-methanesulfonamide

butanedioic acid; 1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide

butanedioic acid;1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide

C14H21N3O2S.C4H6O4

C18H27N3O6S

CCG-100994

CHEBI:64359

CHEMBL1201150

CPD000469158

CS-1884

CTK8F0759

D00676

Diletan

DTXSID60145966

F0001-2411

FT-0651836

GR 43175C

GR-43175 SUCCINATE

GR-43175C

H689

HE274835

HE301771

HMS2051H04

HMS2090G21

HMS2231K14

HMS3370G19

HMS3393H04

HMS3651E11

HY-B0121

I14-0769

Imigran

Imigran;mitrex;Imitrex;Suminat;Sumitrex

Imigrane

Imijekt

Imitrex

Imitrex Statdose

J8BDZ68989

Jsp000369

KB-217142

LS-45735

MFCD00902856

Micralgin

Migmax

Migratan

Migratriptan

mitrex

MLS001401405

MLS006011969

MolPort-003-850-372

N,N-dimethyl-2-{5-[(methylsulfamoyl)methyl]-1H-indol-3-yl}ethanaminium 3-carboxypropanoate

NC00244

Novelian

NSC-760362

NSC760362

Onzetra Xsail

Permicran

Pharmakon1600-01505372

PORMUFZNYQJOEI-UHFFFAOYSA-N

Q-201772

RT-015829

S0851

s1432

SAM001246579

SC-19151

SCHEMBL41674

SMR000469158

SN-308

ST24026862

ST51053944

SUCCINIC ACID-1-(3-[2-(DIMETHYLAMINO)ETHYL]-1H-INDOL-5-YL)-N-METHYLMETHANESULFONAMIDE (1:1)

succinic acid; sumatriptan

Sumadol

Sumatrin

Sumatriptan (succinate)

Sumatriptan for system suitability, European Pharmacopoeia (EP) Reference Standard

sumatriptan hydrogen succinate

Sumatriptan SDI

Sumatriptan succinate (JAN/USAN)

Sumatriptan succinate [USAN]

Sumatriptan succinate, >=98% (HPLC), solid

Sumatriptan succinate, European Pharmacopoeia (EP) Reference Standard

Sumatriptan succinate, United States Pharmacopeia (USP) Reference Standard

Sumave dosepro (TN)

Sumavel DosePro

Sumigrene

Suminat

Sumitrex

TL8000157

TO-303S

UNII-J8BDZ68989

Z1551429732

Zecutity (TN)

Zelrix

Zembrace SymTouch

Tentative approvals for SUMATRIPTAN SUCCINATE

Applicant	Application No.	Strength	Dosage Form
		EQ 25MG BASE	TABLET;ORAL
		EQ 100MG BASE	TABLET;ORAL
		EQ 50MG BASE	TABLET;ORAL

US Patents and Regulatory Information for sumatriptan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Inc	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	090495-001	Jan 29, 2014	AB	RX	No	No
Avanir Pharms	ONZETRA XSAIL	sumatriptan succinate	POWDER;INHALATION	206099-001	Jan 27, 2016		RX	Yes	Yes
Apotex Inc	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	200263-001	Jun 19, 2012	AB	RX	No	No
Avanir Pharms	ONZETRA XSAIL	sumatriptan succinate	POWDER;INHALATION	206099-001	Jan 27, 2016		RX	Yes	Yes			Y

Expired US Patents for sumatriptan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-002	Feb 1, 2006
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-003	Dec 23, 1996
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-003	Dec 23, 1996

Non-Orange Book US Patents for sumatriptan succinate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,629,960	Needleless injector
8,555,878	Nasal delivery device
8,596,278	Nasal devices
8,663,158	Needleless injector drug capsule and a method for filling thereof

International Patents for sumatriptan succinate

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	02068029
Israel	213855
Japan	5253452
Australia	2002258031