Generic entry timeline

Duragesic generics — when can they launch?

Duragesic (fentanyl) · Johnson & Johnson (Janssen Pharmaceutica) · 68 active US patents · 0 expired

Earliest patent expiry

2027-01-25

1 year remaining

Full patent estate to

2030-04-27

complete protection through 2030

FDA approval

1968-01-01

Johnson & Johnson (Janssen Pharmaceutica)

Where Duragesic sits in the generic timeline

Imminent generic cliff: earliest active US patent for Duragesic 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 — 40 patents
Method of Use — 28 patents

FDA U-codes carved out by Duragesic 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-55`	(no description)

Sample patent estate

Showing 6 of 68 active US patents. View full estate on the Duragesic drug page →

US10016403 Formulation · expires 2027-01-25

This patent protects sublingual formulations containing fentanyl, a pharmaceutically acceptable salt, or derivative thereof, for patient administration.

USPTO title: Sublingual fentanyl spray
US9642797 Method of Use · expires 2027-01-25

This patent protects sublingual fentanyl formulations and methods for treating pain using these formulations.

USPTO title: Sublingual fentanyl spray and methods of use to treat pain
US8835459 Formulation · expires 2027-01-25

This patent protects sublingual formulations containing fentanyl or a derivative thereof for patient administration.

USPTO title: Sublingual fentanyl spray
US9289387 Method of Use · expires 2027-01-25

This patent protects a method of treating pain by administering a sublingual fentanyl spray formulation.

USPTO title: Method of treating pain by administering sublingual fentanyl spray
US9642797 Method of Use · expires 2027-01-25

This patent protects sublingual fentanyl formulations and methods for treating pain using these formulations.

USPTO title: Sublingual fentanyl spray and methods of use to treat pain
US8835460 Method of Use · expires 2027-01-25

This patent protects sublingual formulations containing fentanyl for administration to a patient and methods for treating pain with these formulations.

USPTO title: Sublingual fentanyl spray and methods of treating pain

Sources

FDA Orange Book — patents listed against Duragesic (NDA filed 1968)
Duragesic drug profile — full patent estate, indications, clinical trials, pricing
Johnson & Johnson (Janssen Pharmaceutica) patent portfolio
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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