Skip to content
Drybench

Drybench Patent.

FINGOLIMOD HYDROCHLORIDE, NDA 022527

The patents and exclusivities FDA's Orange Book lists for NDA 022527 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured
14 October 2026
Paragraph IV list captured
17 October 2026
Last checked
30 October 2026
Data-branch commit
dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the appFINGOLIMOD HYDROCHLORIDE in the molecule app

Listed protection

Listed dates run from 25 Dec 2027 to 30 Sep 2032, each by its own rule; no one date stands for this product.

Earliest listed date
25 Dec 2027US 10,543,179, use patentRule R1 · Product 001 · patent.txt line 2,049
Latest listed date
30 Sep 2032US 9,592,208 with pediatric exclusivity, as listedRule R2 · Product 002 · patent.txt line 2,050
Latest substance patent
None listed
Latest listed patent
30 Sep 2032US 9,592,208 with pediatric exclusivity, as listedRule R2 · Product 002 · patent.txt line 2,050
Latest exclusivity
None listed

2 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 022527, as listed. The sections below name products by these numbers.

  • Product 001 · GILENYA

    Dosage form; route
    CAPSULE;ORAL
    Strength
    EQ 0.5MG BASE
    Approval date as listed
    21 Sep 2010
    Type as listed
    RX
    Applicant as listed
    NOVARTIS PHARMACEUTICALS CORP

  • Product 002 · GILENYA

    Dosage form; route
    CAPSULE;ORAL
    Strength
    EQ 0.25MG BASE
    Approval date as listed
    11 May 2018
    Type as listed
    RX
    Applicant as listed
    NOVARTIS PHARMACEUTICALS CORP

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

3 entries from 3 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 10,543,179, use patent

    patent.txt line 2,049
    Expiry as listed
    25 Dec 2027
    Rule
    R1
    Flags
    use code U-2719
    Product numbers
    001

  • US 9,592,208, product and use patent

    patent.txt line 2,051
    Expiry as listed
    30 Mar 2032
    Rule
    R1
    Flags
    product · use code U-2315
    Product numbers
    002

  • US 9,592,208 with pediatric exclusivity, as listed

    patent.txt line 2,050
    Expiry as listed
    30 Sep 2032
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    002

Listed exclusivities

Each exclusivity FDA lists for NDA 022527, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 022527.

Paragraph IV list rows giving NDA 022527

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 022527, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 022527

  • Fingolimod · Capsules · 0.5 mg

    RLD/NDA as listed: Gilenya 22527
    First PIV submission
    22 Sep 2014
    ANDAs
    19
    180-day status
    Eligible
    Decision posted
    2 Jan 2020
    First applicant approval
    4 Dec 2019
    First marketing
    21 Sep 2022
    Last qualifying patent expiry (as listed by FDA)
    29 Mar 2026

  • Fingolimod · Capsules · 0.25 mg

    RLD/NDA as listed: Gilenya 22527
    First PIV submission
    19 Jul 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Nov 2021
    First applicant approval
    12 Nov 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Mar 2032

Notes from the trace

  • R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week