Trulance generics — when can they launch?
Trulance (PLECANATIDE) · Salix · 10 active US patents · 0 expired
Where Trulance sits in the generic timeline
Imminent generic cliff: earliest active US patent for Trulance expires in 2028 (~2 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 — 6 patents
- Composition of Matter — 2 patents
- Method of Use — 2 patents
FDA U-codes carved out by Trulance 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-2230 | (no description) |
U-1999 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Trulance drug page →
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This patent protects a method of treating inflamed, pre-cancerous, or cancerous tissue in mammals using a guanylate cyclase receptor agonist and/or a cGMP-dependent phosphodiesterase inhibitor.USPTO title: Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
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This patent protects low-dose formulations of guanylate cyclase-C agonist peptides and methods for their use, either alone or in combination with other therapeutic agents.USPTO title: Formulations of guanylate cyclase C agonists and methods of use
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This patent protects low-dose formulations of guanylate cyclase-C agonist peptides, which can be used alone or in combination with other therapeutic agents.USPTO title: Formulations of guanylate cyclase C agonists and methods of use
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This patent protects low-dose formulations of guanylate cyclase-C agonist peptides and methods for their use, either alone or in combination with other therapeutic agents.USPTO title: Formulations of guanylate cyclase C agonists and methods of use
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This patent protects processes for purifying a peptide that acts as an agonist of guanylate cyclase C, including a solvent exchange and freeze-drying step.USPTO title: Ultra-pure agonists of guanylate cyclase C, method of making and using same
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This patent protects low-dose formulations of guanylate cyclase-C agonist peptides and methods for their use, including administration with other therapeutic agents.USPTO title: Formulations of guanylate cyclase C agonists and methods of use
Sources
- FDA Orange Book — patents listed against Trulance (NDA filed 2017)
- Trulance drug profile — full patent estate, indications, clinical trials, pricing
- Salix patent portfolio
- Patent cliff 2028 — 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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