MOXIFLOXACIN HYDROCHLORIDE generics — when can they launch?
MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN HYDROCHLORIDE) · · 2 active US patents · 0 expired
Where MOXIFLOXACIN HYDROCHLORIDE sits in the generic timeline
Imminent generic cliff: earliest active US patent for MOXIFLOXACIN HYDROCHLORIDE 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.
- Formulation — 2 patents
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the MOXIFLOXACIN HYDROCHLORIDE drug page →
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This patent protects pharmaceutical compositions containing a fluoroquinolone antibiotic drug, such as moxifloxacin hydrochloride, in a specific dosage form.USPTO title: Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
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This patent protects pharmaceutical compositions containing a fluoroquinolone antibiotic drug, such as moxifloxacin hydrochloride, in a specific dosage form.USPTO title: Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
Sources
- FDA Orange Book — patents listed against MOXIFLOXACIN HYDROCHLORIDE (NDA filed 1999)
- MOXIFLOXACIN HYDROCHLORIDE 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.
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