TENAPANOR HYDROCHLORIDE generics — when can they launch?
TENAPANOR HYDROCHLORIDE (TENAPANOR HYDROCHLORIDE) · · 24 active US patents · 0 expired
Where TENAPANOR HYDROCHLORIDE sits in the generic timeline
Mid-term cliff: earliest active US patent for TENAPANOR HYDROCHLORIDE expires in 2029 (~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.
- Composition of Matter — 12 patents
- Method of Use — 8 patents
- Formulation — 4 patents
FDA U-codes carved out by TENAPANOR HYDROCHLORIDE 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-2626 | (no description) |
U-381 | (no description) |
U-3736 | (no description) |
Sample patent estate
Showing 6 of 24 active US patents. View full estate on the TENAPANOR HYDROCHLORIDE drug page →
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This patent protects compounds, including Tenapanor Hydrochloride, for treating disorders associated with fluid retention, hypertension, and gastrointestinal tract disorders.USPTO title: Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
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USPTO title: Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
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USPTO title: Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
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This patent protects compounds, including Tenapanor Hydrochloride, for treating disorders associated with fluid retention, hypertension, and gastrointestinal tract disorders.USPTO title: Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
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This patent protects compounds, including Tenapanor Hydrochloride, for treating disorders associated with fluid retention, hypertension, and gastrointestinal tract disorders.USPTO title: Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
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This patent protects compounds, including Tenapanor Hydrochloride, for treating disorders associated with fluid retention, hypertension, and gastrointestinal tract disorders.USPTO title: Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Sources
- FDA Orange Book — patents listed against TENAPANOR HYDROCHLORIDE (NDA filed 2019)
- TENAPANOR 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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