MESALAMINE generics — when can they launch?
MESALAMINE (MESALAMINE) · · 4 active US patents · 0 expired
Where MESALAMINE sits in the generic timeline
Imminent generic cliff: earliest active US patent for MESALAMINE 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.
- Formulation — 2 patents
- Composition of Matter — 1 patent
- Method of Use — 1 patent
FDA U-codes carved out by MESALAMINE 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-1310 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the MESALAMINE drug page →
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This patent protects a packaged enema formulation containing substantially pure 5-ASA as the active ingredient for treating Inflammatory Bowel Disease (IBD).USPTO title: Reduced irritant enema for treatment of inflammatory bowel disease (IBD)
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This patent protects a mesalamine rectal suppository designed to provide improved comfort of use.USPTO title: Mesalamine suppository
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This patent protects a mesalamine rectal suppository designed to provide improved comfort of use.USPTO title: Mesalamine suppository
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This patent protects methods for treating gastrointestinal disorders, including Crohn's disease and ulcerative colitis, using a granulated mesalamine formulation.USPTO title: Compositions and methods for treatment of bowel diseases with granulated mesalamine
Sources
- FDA Orange Book — patents listed against MESALAMINE (NDA filed 1987)
- MESALAMINE 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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