Sumatriptan succinate - Generic Drug Details

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What are the generic sources for sumatriptan succinate and what is the scope of 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, Fresenius Kabi Usa, Hikma, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Endo Ventures Ltd, Currax, Upsher Smith Labs, Teva Branded Pharm, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Inc, 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-seven 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 ninety-four patent family members in thirty countries.

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

Summary for sumatriptan succinate

International Patents:	394
US Patents:	37
Tradenames:	8
Applicants:	34
NDAs:	39
Drug Master File Entries:	24
Suppliers / Packagers:	31
Bulk Api Vendors:	91
Clinical Trials:	21
Patent Applications:	2,006
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for sumatriptan succinate
Drug Sales Revenues:	Drug sales revenues for sumatriptan succinate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sumatriptan succinate
DailyMed Link:	sumatriptan succinate at DailyMed

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Drug Sales Revenue Trends for sumatriptan succinate

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Recent Clinical Trials for sumatriptan succinate

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Sponsor	Phase
Kimberly-Clark Corporation	Phase 1
GlaxoSmithKline	Phase 4
Cady, Roger, M.D.	Phase 4

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Recent Litigation for sumatriptan succinate

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District Court Litigation

Case Name	Date
ADAMAS PHARMA, LLC v. SANDOZ INC.	2018-05-10
Glaxo Group Ltd. v. Spectrum Pharmaceuticals Inc	2006-09-08

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Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE

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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for sumatriptan succinate

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1d Receptor Agonists Serotonin 1b 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-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-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
AKOS015900409
Alsuma
Alsuma (TN)
AN-1097
Antibet
API0009779
Arcoiran
AX8017360
BC208270
BCP05168
BG0326
Butanedioic acid, compd. 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 43175
GR 43175; GW 102; SN 308
GR 43175C
GR-43175C
H689
HMS2051H04
HMS2090G21
HMS2231K14
HMS3370G19
HMS3393H04
HMS3651E11
HMS3714G05
HY-B0121
I14-0769
Imigran
Imigran;mitrex;Imitrex;Suminat;Sumitrex
Imigrane
Imijekt
Imitrex
Imitrex (TN)
Imitrex Statdose
J8BDZ68989
Jsp000369
KB-217142
KS-1116
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
SR-01000763688
SR-01000763688-4
ST24026862
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
SW197624-3
TL8000157
TO-303S
UNII-J8BDZ68989
Z1551429732
Zecutity (TN)
Zelrix
Zembrace SymTouch

Paragraph IV (Patent) Challenges for SUMATRIPTAN SUCCINATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
IMITREX	TABLET;ORAL	sumatriptan succinate	020132

US Patents and Regulatory Information for sumatriptan succinate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Watson Labs	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076933-003	Aug 10, 2009	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for sumatriptan succinate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009	Start Trial	Start Trial
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	Start Trial	Start Trial
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	Start Trial	Start Trial
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-001	Dec 28, 1992	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for sumatriptan succinate

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	02068031	Start Trial
Mexico	2010013644	Start Trial
Portugal	1180378	Start Trial
Mexico	2013005430	Start Trial
>Country	>Patent Number	>Estimated Expiration

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