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Last Updated: February 21, 2020

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Sumatriptan - Generic Drug Details

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

Sumatriptan is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Lannett Co Inc, Upsher Smith Labs, Meridian Medcl, 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, 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 forty-two NDAs. There are forty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan has forty-seven patent family members in fourteen countries.

There are twenty-four drug master file entries for sumatriptan. Four suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for sumatriptan

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Drug Sales Revenue Trends for sumatriptan

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Recent Clinical Trials for sumatriptan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Avanir PharmaceuticalsPhase 3
Eli Lilly and CompanyPhase 1
Montefiore Medical CenterN/A

See all sumatriptan clinical trials

Recent Litigation for sumatriptan

Identify potential future generic entrants

District Court Litigation
Case NameDate
ENDO PHARMACEUTICALS INC. v. LUPIN ATLANTIS HOLDINGS SA2018-06-22
Endo Pharmaceuticals Inc. v. Lupin Atlantis Holdings SA2017-07-28
Glaxo Group Ltd. v. Spectrum Pharmaceuticals Inc2006-09-08

See all sumatriptan litigation

Generic filers with tentative approvals for SUMATRIPTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 100MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 50MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 25MG BASETABLET;ORAL

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

Medical Subject Heading (MeSH) Categories for sumatriptan
Synonyms for sumatriptan
(3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl)-N-methylmethanesulfonamide
(3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl)-N-methylmethanesulfonamide #
1-(3-(2-(dimethylamino)ethyl)-1H-indol-5-yl)-N-methylmethanesulfonamide
1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]-N-methyl-methanesulfonamide
1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]-N-methylmethanesulfonamide
1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]-N-methyl-methanesulfonamide
1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide
103628-46-2
103628-48-4 (succinate)
1H-Indole-5-methanesulfonamide, 3-(2-(dimethylamino)ethyl)-N-methyl-
3-(2-(Dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulfonamide
3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole -5-methanesulphonamide
3-[2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide
3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide
3-[2-(Dimethylamino)ethyl]-N-methylindole-5-methanesulfonamide
628S462
8R78F6L9VO
AB0016356
AB00698285_14
AB00698285_15
AB00698285-12
AB00698285-13
AC1L1K6B
AJ-08373
AKOS015894924
AN-5271
API0004291
AVP 825
AVP-825
AVP825
BCP02237
BDBM50005835
BIDD:GT0248
BRD-K50938287-001-01-7
BRN 6930870
BSPBio_002304
C07319
C14H21N3O2S
CAS-103628-46-2
CCG-230331
CHEBI:10650
CHEMBL128
D00451
DB00669
DSSTox_CID_3628
DSSTox_GSID_23628
DSSTox_RID_77118
DTXSID4023628
FT-0631027
GR 43175
GR 43175X
GR-43175
GTPL54
HMS2231B21
HMS3369A05
HSDB 7742
I06-0076
Imigran (TN)
Imigran Recovery
Imitrex (TN)
Imitrex Oral
Imitrex, Imigran ,Treximet
J-001014
KB-217141
KQKPFRSPSRPDEB-UHFFFAOYSA-N
L000584
LS-83175
MCULE-3991948648
MLS001195659
MLS001304742
MolPort-002-885-863
NCGC00095838-01
NCGC00095838-02
NCGC00095838-03
NCGC00095838-04
O262
Onzetra Xsail
SBI-0206837.P001
SC-18016
SCHEMBL1482
SMR000596517
SPECTRUM1505372
STL451003
Sumatran
Sumatriptan (JAN/USP/INN)
Sumatriptan [USP:INN:BAN]
Sumatriptanum
Sumatriptanum [INN-Latin]
Sumax
Tox21_111528
Tox21_111528_1
UNII-8R78F6L9VO
Zecuity
Zembrace SymTouch
ZINC14360

US Patents and Regulatory Information for sumatriptan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Pharms SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 078298-001 May 21, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Fosun Pharma SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 076976-002 Aug 10, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Hikma Pharms SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 078298-003 May 21, 2013 DISCN No No   Start Trial   Start Trial   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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Merck
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Colorcon
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.