Is there a generic for Fingolimod lauryl sulfate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Fingolimod lauryl sulfate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Fingolimod lauryl sulfate?

TASCENSO ODT (NDA 214962, CYCLE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Fingolimod lauryl sulfate?

The Orange Book lists 3 patents against Fingolimod lauryl sulfate products, with the earliest listed expiry in 2036. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Fingolimod lauryl sulfate are approved?

Fingolimod lauryl sulfate is approved in the following dosage form: tablet, orally disintegrating.

FDA Orange Book · active-ingredient family

Fingolimod lauryl sulfate

Fingolimod lauryl sulfate: 1 brand, 0 generics; first approved Dec 23, 2021; on patent until Jan 19, 2036.

On patent

Generic status & protection

Protected until Jan 19, 2036 (earliest listed patent expiry).

Earliest patent expiry Jan 19, 2036

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 19, 2036

in 9 yr 8 mo

Originator applications

Brand (NDA) products

TASCENSO ODTRLD

CYCLENDA 21496220212 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	—
EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10555902	Jan 19, 2036	in 9 yr 8 mo	U-3268
9925138	Jan 19, 2036	in 9 yr 8 mo	Product
10925829	Jan 19, 2036	in 9 yr 8 mo	Product

FDA approval span

Approval history

First approval

Dec 23, 2021

4 yr 7 mo ago

Most recent approval

Dec 09, 2022

3 yr 8 mo ago

Approvals span 2021–2022 across 1 FDA application.

Brand (NDA) 1100%

Generic (ANDA) 00%

Fingolimod lauryl sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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