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Last Updated: November 4, 2024

FINGOLIMOD LAURYL SULFATE - Generic Drug Details


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What are the generic sources for fingolimod lauryl sulfate and what is the scope of freedom to operate?

Fingolimod lauryl sulfate is the generic ingredient in one branded drug marketed by Cycle and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fingolimod lauryl sulfate has seven patent family members in seven countries.

One supplier is listed for this compound.

Summary for FINGOLIMOD LAURYL SULFATE
International Patents:7
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in FINGOLIMOD LAURYL SULFATE?FINGOLIMOD LAURYL SULFATE excipients list
DailyMed Link:FINGOLIMOD LAURYL SULFATE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FINGOLIMOD LAURYL SULFATE
Generic Entry Date for FINGOLIMOD LAURYL SULFATE*:
Constraining patent/regulatory exclusivity:
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 FINGOLIMOD LAURYL SULFATE

US Patents and Regulatory Information for FINGOLIMOD LAURYL SULFATE

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 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 ⤷  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 FINGOLIMOD LAURYL SULFATE

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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FINGOLIMOD LAURYL SULFATE

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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.