Mobic generics — when can they launch?
Mobic (MELOXICAM) · Boehringer Ingelheim · 97 active US patents · 0 expired
Where Mobic sits in the generic timeline
Mid-term cliff: earliest active US patent for Mobic expires in 2030 (~4 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 85 patents
- Formulation — 11 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Mobic 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-2750 | (no description) |
U-3318 | (no description) |
U-2165 | (no description) |
U-2160 | (no description) |
U-1719 | (no description) |
U-4133 | (no description) |
U-4134 | (no description) |
U-4135 | (no description) |
U-4136 | (no description) |
U-4356 | (no description) |
U-3038 | (no description) |
Sample patent estate
Showing 6 of 97 active US patents. View full estate on the Mobic drug page →
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This patent protects a method to reduce flake-like aggregation in nanoparticulate active agent compositions, such as those used in a drug product.USPTO title: Reduction of flake-like aggregation in nanoparticulate active agent compositions
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This patent protects nanoparticulate compositions of meloxicam, a drug listed against Mobic, with an average particle size of less than about 2000 nm.USPTO title: Nanoparticulate meloxicam formulations
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This patent protects a method to reduce flake-like aggregation in nanoparticulate active agent compositions, such as those used in a drug product.USPTO title: Reduction of flake-like aggregation in nanoparticulate active agent compositions
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This patent protects fast disintegrating compositions of meloxicam, a pharmaceutical formulation suitable for rapid release in the oral cavity.USPTO title: Fast disintegrating compositions of meloxicam
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This patent protects fast disintegrating compositions of meloxicam, a pharmaceutical formulation suitable for rapid release in the oral cavity.USPTO title: Fast disintegrating compositions of meloxicam
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This patent protects a formulation of meloxicam in unit dosage forms containing either 5 mg or 10 mg of meloxicam.USPTO title: Formulation of meloxicam
Sources
- FDA Orange Book — patents listed against Mobic (NDA filed 2000)
- Mobic drug profile — full patent estate, indications, clinical trials, pricing
- Boehringer Ingelheim patent portfolio
- Patent cliff 2030 — 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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