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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 214962


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NDA 214962 describes TASCENSO ODT, which is a drug marketed by Cycle and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the TASCENSO ODT profile page.

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.
Summary for 214962
Tradename:TASCENSO ODT
Applicant:Cycle
Ingredient:fingolimod lauryl sulfate
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214962
Generic Entry Date for 214962*:
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 NDA: 214962
Suppliers and Packaging for NDA: 214962
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TASCENSO ODT fingolimod lauryl sulfate TABLET, ORALLY DISINTEGRATING;ORAL 214962 NDA Cycle Pharmaceuticals Ltd 70709-062 70709-062-30 3 BLISTER PACK in 1 CARTON (70709-062-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
TASCENSO ODT fingolimod lauryl sulfate TABLET, ORALLY DISINTEGRATING;ORAL 214962 NDA Cycle Pharmaceuticals Ltd 70709-065 70709-065-30 3 BLISTER PACK in 1 CARTON (70709-065-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 0.25MG BASE
Approval Date:Dec 23, 2021TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 19, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MULTIPLE SCLEROSIS IN PEDIATRIC PATIENTS 10 YEARS OF AGE AND OLDER AND WEIGHING LESS THAN OR EQUAL TO 40 KG
Patent:⤷  Sign UpPatent Expiration:Jan 19, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 19, 2036Product Flag?YSubstance Flag?Delist Request?

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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.