Generic entry timeline

DURLOBACTAM SODIUM generics — when can they launch?

DURLOBACTAM SODIUM (DURLOBACTAM SODIUM) · · 4 active US patents · 0 expired

Earliest patent expiry

2033-04-02

7 years remaining

Full patent estate to

2035-11-17

complete protection through 2035

FDA approval

2023

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Where DURLOBACTAM SODIUM sits in the generic timeline

Long-dated protection: earliest active US patent for DURLOBACTAM SODIUM extends to 2033 (~7 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

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 — 3 patents
Composition of Matter — 1 patent

FDA U-codes carved out by DURLOBACTAM SODIUM 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-2840`	(no description)

Sample patent estate

Showing 4 of 4 active US patents. View full estate on the DURLOBACTAM SODIUM drug page →

US9309245 Composition of Matter · expires 2033-04-02

This patent protects beta-lactamase inhibitor compounds, including their pharmaceutically acceptable salts, for treating bacterial infections.

USPTO title: Beta-lactamase inhibitor compounds
US9623014 Method of Use · expires 2033-04-02

This patent protects beta-lactamase inhibitor compounds, including their salts, for use in treating bacterial infections, including those caused by drug-resistant organisms.

USPTO title: Î²-lactamase inhibitor compounds
US10376499 Method of Use · expires 2035-11-17

This patent protects a combination of a beta-lactamase inhibitor with sulbactam, and optionally imipenem/cilastatin, for treating bacterial infections.

USPTO title: Combination therapy for treatment of resistant bacterial infections
US9968593 Method of Use · expires 2035-11-17

This patent protects a combination of a beta-lactamase inhibitor with sulbactam, and optionally imipenem/cilastatin, for treating bacterial infections.

USPTO title: Combination therapy for treatment of resistant bacterial infections

Sources

FDA Orange Book — patents listed against DURLOBACTAM SODIUM (NDA filed 2023)
DURLOBACTAM SODIUM drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2033 — 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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