Tembexa generics — when can they launch?
Tembexa (BRINCIDOFOVIR) · Emergent Biodefense · 6 active US patents · 0 expired
Where Tembexa sits in the generic timeline
Mid-term cliff: earliest active US patent for Tembexa 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 — 4 patents
- Formulation — 1 patent
- Composition of Matter — 1 patent
FDA U-codes carved out by Tembexa 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-3165 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Tembexa drug page →
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This patent protects methods of synthesizing phosphonate ester derivatives, including preferred methods for large-scale preparation with high purity.USPTO title: Phosphonate ester derivatives and methods of synthesis thereof
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This patent protects methods of synthesizing phosphonate ester derivatives, including preferred methods for large-scale preparation with high purity.USPTO title: Phosphonate ester derivatives and methods of synthesis thereof
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This patent protects methods of synthesizing phosphonate ester compounds and their morphic forms, allowing for large-scale preparation with high purity and stability.USPTO title: Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
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This patent protects methods of synthesis for phosphonate ester compounds, including those with high purity and stability, and their morphic forms.USPTO title: Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
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This patent protects methods of synthesis for phosphonate ester compounds, including those with high purity and stability, and their morphic forms.USPTO title: Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
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This patent protects methods of synthesizing phosphonate ester compounds and their morphic forms, allowing for large-scale preparation with high purity and stability.USPTO title: Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
Sources
- FDA Orange Book — patents listed against Tembexa (NDA filed 2021)
- Tembexa drug profile — full patent estate, indications, clinical trials, pricing
- Emergent Biodefense 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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