Mytesi generics — when can they launch?
Mytesi (CROFELEMER) · Napo Pharms Inc · 2 active US patents · 0 expired
Where Mytesi sits in the generic timeline
Mid-term cliff: earliest active US patent for Mytesi expires in 2031 (~5 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 — 2 patents
FDA U-codes carved out by Mytesi 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-1319 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Mytesi drug page →
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This patent protects methods for treating diarrhea, including HIV-associated diarrhea, by administering an inhibitor of chloride-ion transport, such as crofelemer.USPTO title: Methods and compositions for treating HIV-associated diarrhea
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This patent protects methods for treating diarrhea, including HIV-associated diarrhea, by administering an inhibitor of chloride-ion transport, such as crofelemer.USPTO title: Methods and compositions for treating HIV-associated diarrhea
Sources
- FDA Orange Book — patents listed against Mytesi (NDA filed 2012)
- Mytesi drug profile — full patent estate, indications, clinical trials, pricing
- Napo Pharms Inc patent portfolio
- Patent cliff 2031 — 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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