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 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.
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.
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
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
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: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 0.25MG BASE | ||||
| Approval Date: | Dec 23, 2021 | TE: | RLD: | Yes | |||||
| Patent: | 10,555,902 | Patent Expiration: | Jan 19, 2036 | Product 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: | 10,925,829 | Patent Expiration: | Jan 19, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,925,138 | Patent Expiration: | Jan 19, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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