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ONZETRA XSAIL Drug Profile

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Which patents cover Onzetra Xsail, and what generic alternatives are available?

Onzetra Xsail is a drug marketed by Currax and is included in one NDA. There are eighteen patents protecting this drug.

This drug has two hundred and sixty-one patent family members in twenty-eight countries.

The generic ingredient in ONZETRA XSAIL is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.

US ANDA Litigation and Generic Entry Outlook for Onzetra Xsail

A generic version of ONZETRA XSAIL was approved as sumatriptan succinate by WEST-WARD PHARMS INT on February 6^th, 2009.

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Summary for ONZETRA XSAIL

International Patents:	261
US Patents:	18
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	45
Clinical Trials:	1
Patent Applications:	4,015
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ONZETRA XSAIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONZETRA XSAIL
DailyMed Link:	ONZETRA XSAIL at DailyMed

Drug patent expirations by year for ONZETRA XSAIL

Recent Clinical Trials for ONZETRA XSAIL

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Sponsor	Phase
Avanir Pharmaceuticals	Phase 3

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Recent Litigation for ONZETRA XSAIL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ADAMAS PHARMA, LLC v. SANDOZ INC.	2018-05-10

See all ONZETRA XSAIL litigation

Pharmacology for ONZETRA XSAIL

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

Synonyms for ONZETRA XSAIL

(3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl)-N-methylmethanesulfonamide
(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-methylmethanesulfonamide
103628-46-2
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
AKOS015894924
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 43175X
GR-43175
GTPL54
HMS2231B21
HMS3369A05
HSDB 7742
Imigran (TN)
Imigran Recovery
Imitrex (TN)
J-001014
KQKPFRSPSRPDEB-UHFFFAOYSA-N
L000584
LS-83175
MCULE-3991948648
MLS001195659
MLS001304742
N02CC01
NCGC00095838-01
NCGC00095838-02
NCGC00095838-03
NCGC00095838-04
O262
Q416978
SBI-0206837.P001
SC-18016
SCHEMBL1482
SMR000596517
SPECTRUM1505372
STL451003
Sumatran
sumatriptan
Sumatriptan (JAN/USP/INN)
Sumatriptan [USP:INN:BAN]
Sumatriptanum
Sumatriptanum [INN-Latin]
Sumax
Tosymra (nasal spray)
Tox21_111528
Tox21_111528_1
UNII-8R78F6L9VO
Zecuity
Zembrace SymTouch
ZINC14360

US Patents and Regulatory Information for ONZETRA XSAIL

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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
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
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				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 ONZETRA XSAIL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	Start Trial	Start Trial
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ONZETRA XSAIL

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Country	Patent Number	Estimated Expiration
Russian Federation	2644269	Start Trial
Mexico	358061	Start Trial
Singapore	11201405179V	Start Trial
United Kingdom	2381460	Start Trial
Spain	2479719	Start Trial
South Korea	20010103036	Start Trial
Japan	2011031088	Start Trial
>Country	>Patent Number	>Estimated Expiration