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TASCENSO ODT Drug Patent Profile

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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.

This drug has seven patent family members in seven countries.

The generic ingredient in TASCENSO ODT is fingolimod lauryl sulfate. There are twenty-one drug master file entries 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.

Indicators of Generic Entry

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Summary for TASCENSO ODT

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for TASCENSO ODT
What excipients (inactive ingredients) are in TASCENSO ODT?	TASCENSO ODT excipients list
DailyMed Link:	TASCENSO ODT at DailyMed

Drug patent expirations by year for TASCENSO ODT

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

Generic Entry Date for TASCENSO ODT^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TASCENSO ODT is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TASCENSO ODT

Stable fingolimod dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MULTIPLE SCLEROSIS IN PEDIATRIC PATIENTS 10 YEARS OF AGE AND OLDER AND WEIGHING LESS THAN OR EQUAL TO 40 KG

Stable fingolimod dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS) IN PATIENTS 10 YEARS OF AGE AND OLDER

Stable solid fingolimod dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

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

Patent: 16209466
Patent: Stable solid fingolimod dosage forms
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 74375
Patent: FORME GALENIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 7530301
Patent: 稳定的固体芬戈莫德剂型 (STABLE SOLID FINGOLIMOD DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 47341
Patent: FORME GALÉNIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 18502168
Patent: 安定な固体フィンゴリモド剤形
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 1642842
Patent: Stable solid FINGOLIMOD dosage forms
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Taiwan	201642842	Stable solid FINGOLIMOD dosage forms	⤷ Sign Up
Australia	2016209466	Stable solid fingolimod dosage forms	⤷ Sign Up
European Patent Office	3247341	FORME GALÉNIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS)	⤷ Sign Up
China	107530301	稳定的固体芬戈莫德剂型 (STABLE SOLID FINGOLIMOD DOSAGE FORMS)	⤷ Sign Up
Canada	2974375	FORME GALENIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS)	⤷ Sign Up
Japan	2018502168	安定な固体フィンゴリモド剤形	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016118515		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TASCENSO ODT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	28/2011	Austria	⤷ Sign Up	PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317
1613288	2011C/030	Belgium	⤷ Sign Up	PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
1613288	C20110013 00043	Estonia	⤷ Sign Up	PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
0627406	C300488	Netherlands	⤷ Sign Up	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
1613288	C 2011 005	Romania	⤷ Sign Up	PRODUCT NAME: FINGOLIMOD SI SARURILE SALE ACCEPTABILE FARMACEUTIC INSPECIAL SARE CLORHIDRAT 2-AMINO-2[2-(4-OCTILFENIL)ETIL]PROPAN-1,3 DIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/677/001, RO EU/1/11/677/002, RO EU/1/11/677/003, RO EU/1/11/677/004; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/677/001, EMEA EU/1/11/677/002, EMEA EU/1/11/677/003, EMEA EU/1/11/677/004; DATE OF FIRST AUTHORISATION IN EEA: 20110317
1613288	CR 2011 00023	Denmark	⤷ Sign Up	PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317
1613288	2011/027	Ireland	⤷ Sign Up	PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description