Generic entry timeline

UMECLIDINIUM BROMIDE generics — when can they launch?

UMECLIDINIUM BROMIDE (UMECLIDINIUM BROMIDE) · · 7 active US patents · 0 expired

Earliest patent expiry

2027-06-14

1 year remaining

Full patent estate to

2030-11-29

complete protection through 2030

FDA approval

2013

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Where UMECLIDINIUM BROMIDE sits in the generic timeline

Imminent generic cliff: earliest active US patent for UMECLIDINIUM BROMIDE 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.

Method of Use — 2 patents
Composition of Matter — 2 patents
Formulation — 2 patents
Other — 1 patent

FDA U-codes carved out by UMECLIDINIUM BROMIDE 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-1476`	(no description)
`U-3203`	(no description)

Sample patent estate

Showing 6 of 7 active US patents. View full estate on the UMECLIDINIUM BROMIDE drug page →

US8511304 Method of Use · expires 2027-06-14

This patent protects a medicament dispenser for use with multiple elongate form medicament carriers that hold distinct medicament dose portions.

USPTO title: Medicament dispenser
US8511304 Other · expires 2027-12-14

This patent protects a medicament dispenser for use with multiple elongate form medicament carriers that have multiple distinct medicament dose portions.

USPTO title: Medicament dispenser
US7488827 Composition of Matter · expires 2027-12-18

This patent protects muscarinic acetylcholine receptor antagonists, including the active drug substance Umeclidinium bromide.

USPTO title: Muscarinic acetylcholine receptor antagonists
US7488827 Composition of Matter · expires 2027-12-18

This patent protects muscarinic acetylcholine receptor antagonists, including the active drug substance Umeclidinium bromide.

USPTO title: Muscarinic acetylcholine receptor antagonists
US12396986 Formulation · expires 2030-11-29

This patent provides combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist for inhaled administration via the nose or mouth.

USPTO title: Combinations of a muscarinic receptor antagonist and a Î²-2 adrenoreceptor agonist
US11090294 Method of Use · expires 2030-11-29

This patent provides combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist for inhaled administration via the nose or mouth.

USPTO title: Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist

Sources

FDA Orange Book — patents listed against UMECLIDINIUM BROMIDE (NDA filed 2013)
UMECLIDINIUM BROMIDE 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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