Generic entry timeline

FINGOLIMOD HYDROCHLORIDE generics — when can they launch?

FINGOLIMOD HYDROCHLORIDE (FINGOLIMOD HYDROCHLORIDE) · · 3 active US patents · 0 expired

Earliest patent expiry

2027-12-25

2 years remaining

Full patent estate to

2032-09-30

complete protection through 2032

FDA approval

2010

—

Where FINGOLIMOD HYDROCHLORIDE sits in the generic timeline

Imminent generic cliff: earliest active US patent for FINGOLIMOD HYDROCHLORIDE expires in 2027 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

Method of Use — 2 patents
Other — 1 patent

FDA U-codes carved out by FINGOLIMOD HYDROCHLORIDE patents

Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.

U-code	Description
`U-2719`	(no description)
`U-2315`	(no description)

Sample patent estate

Showing 3 of 3 active US patents. View full estate on the FINGOLIMOD HYDROCHLORIDE drug page →

US10543179 Method of Use · expires 2027-12-25

This patent protects a dosage regimen of fingolimod or a pharmaceutically acceptable salt thereof, administered at a daily dosage of 0.5 mg, preceded by vaccination and infection testing.

USPTO title: Dosage regimen of an S1P receptor modulator
US9592208 Method of Use · expires 2032-03-30

This patent protects a solid oral pharmaceutical composition containing a S1P receptor modulator, a filler, and a cyclodextrin.

USPTO title: Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
US9592208 Other · expires 2032-09-30

This patent protects a solid oral pharmaceutical composition containing a S1P receptor modulator, a filler, and a cyclodextrin.

USPTO title: Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol

Sources

FDA Orange Book — patents listed against FINGOLIMOD HYDROCHLORIDE (NDA filed 2010)
FINGOLIMOD HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2027 — every drug losing US exclusivity that year

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

Get generic entry alerts

Free Pharma CI alerts on FINGOLIMOD HYDROCHLORIDE — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.

Subscribe free →