TASCENSO ODT Drug Patent Profile

When do Tascenso Odt patents expire, and when can generic versions of Tascenso Odt launch?

Tascenso Odt is a drug marketed by Cycle and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in TASCENSO ODT is fingolimod lauryl sulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod lauryl sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tascenso Odt

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 19, 2036. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TASCENSO ODT

US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for TASCENSO ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TASCENSO ODT
What excipients (inactive ingredients) are in TASCENSO ODT?	TASCENSO ODT excipients list
DailyMed Link:	TASCENSO ODT at DailyMed

See drug prices for TASCENSO ODT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TASCENSO ODT

Constraining patent/regulatory exclusivity:

10,925,829

NDA:

214962

Dosage:

TABLET, ORALLY DISINTEGRATING;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TASCENSO ODT

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

US Patents and Regulatory Information for TASCENSO ODT

TASCENSO ODT is protected by four US patents.

This potential generic entry date is based on patent 10,925,829.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	10,555,902
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	10,555,902
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	9,925,138		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	10,925,829		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	9,925,138		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	10,925,829		Y

International Patents for TASCENSO ODT

When does loss-of-exclusivity occur for TASCENSO ODT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Japan

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TASCENSO ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2016209466
Canada	2974375
China	107530301
European Patent Office	3247341
Japan	2018502168
Taiwan	201642842

Supplementary Protection Certificates for TASCENSO ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0627406	C300488	Netherlands		PRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
0627406	SPC/GB11/026	United Kingdom		PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
0627406	11C0021	France		PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
0627406	1190015-6	Sweden		PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
0627406	2011020	Ireland		PRODUCT: GILENYA FINGOLIMOD AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF REGISTRATION NO/DATE: IRELAND EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011; FIRST REGISTRATION NO/DATE: EUROPEAN UNION EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011
1613288	C300497	Netherlands		PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317