Generic entry timeline

ZOLIFLODACIN generics — when can they launch?

ZOLIFLODACIN (ZOLIFLODACIN) · · 6 active US patents · 0 expired

Earliest patent expiry

2029-10-13

3 years remaining

Full patent estate to

2034-01-21

complete protection through 2034

FDA approval

—

Where ZOLIFLODACIN sits in the generic timeline

Imminent generic cliff: earliest active US patent for ZOLIFLODACIN expires in 2029 (~3 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 — 5 patents
Composition of Matter — 1 patent

FDA U-codes carved out by ZOLIFLODACIN 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-4369`	(no description)

Sample patent estate

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

US9040528 Method of Use · expires 2029-10-13

This patent protects chemical compounds and their salts, as well as methods for using them to treat bacterial infections.

USPTO title: Chemical compounds 542
US8658641 Composition of Matter · expires 2030-06-20

This patent protects novel compounds of Formula (I) and their pharmaceutically acceptable salts for treating bacterial infections.

USPTO title: Fused, spirocyclic heteroaromatic compounds for the treatment of bacterial infections
US9839641 Method of Use · expires 2034-01-21

This patent discloses compounds and their uses for treating bacterial infections.

USPTO title: Compounds and methods for treating bacterial infections
US9540394 Method of Use · expires 2034-01-21

This patent discloses compounds and their uses for treating bacterial infections.

USPTO title: Compounds and methods for treating bacterial infections
US9187495 Method of Use · expires 2034-01-21

This patent discloses compounds and their uses for treating bacterial infections.

USPTO title: Compounds and methods for treating bacterial infections
US8889671 Method of Use · expires 2034-01-21

This patent discloses compounds and their uses for treating bacterial infections.

USPTO title: Compounds and methods for treating bacterial infections

Sources

FDA Orange Book — patents listed against ZOLIFLODACIN (NDA)
ZOLIFLODACIN drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2029 — 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 ZOLIFLODACIN — 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 →