Generic entry timeline

SUFENTANIL CITRATE generics — when can they launch?

SUFENTANIL CITRATE (SUFENTANIL CITRATE) · · 21 active US patents · 0 expired

Earliest patent expiry

2027-01-05

1 year remaining

Full patent estate to

2038-02-02

complete protection through 2038

FDA approval

1984

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Where SUFENTANIL CITRATE sits in the generic timeline

Imminent generic cliff: earliest active US patent for SUFENTANIL CITRATE expires in 2027 (~1 year 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.

Formulation — 11 patents
Method of Use — 10 patents

FDA U-codes carved out by SUFENTANIL CITRATE 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-1351`	(no description)

Sample patent estate

Showing 6 of 21 active US patents. View full estate on the SUFENTANIL CITRATE drug page →

US8226978 Method of Use · expires 2027-01-05

This patent protects small volume oral transmucosal dosage forms containing sufentanil for the treatment of pain.

USPTO title: Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
US8535714 Method of Use · expires 2027-01-05

This patent protects small volume oral transmucosal dosage forms of sufentanil citrate for the treatment of pain.

USPTO title: Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
US8865211 Method of Use · expires 2027-01-05

This patent protects bioadhesive drug formulations for delivering a drug to the oral mucosa, specifically for use with a subject.

USPTO title: Bioadhesive drug formulations for oral transmucosal delivery
US10245228 Method of Use · expires 2027-01-05

This patent protects small volume oral transmucosal dosage forms of sufentanil citrate for sublingual administration to treat pain.

USPTO title: Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
US8252329 Formulation · expires 2027-01-05

This patent protects bioadhesive drug formulations for oral transmucosal delivery, including single dose applicators and devices for delivering the formulations to the oral mucosa.

USPTO title: Bioadhesive drug formulations for oral transmucosal delivery
US8778393 Method of Use · expires 2027-01-05

This patent protects small volume oral transmucosal dosage forms containing sufentanil for the treatment of pain.

USPTO title: Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain

Sources

FDA Orange Book — patents listed against SUFENTANIL CITRATE (NDA filed 1984)
SUFENTANIL CITRATE 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.

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