Emend generics — when can they launch?
Emend (APREPITANT) · Merck & Co. · 31 active US patents · 0 expired
Where Emend sits in the generic timeline
Imminent generic cliff: earliest active US patent for Emend 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.
- Method of Use — 16 patents
- Formulation — 15 patents
FDA U-codes carved out by Emend 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-901 | (no description) |
U-1743 | (no description) |
U-1916 | (no description) |
U-2161 | (no description) |
U-3787 | (no description) |
U-3440 | (no description) |
U-3690 | (no description) |
Sample patent estate
Showing 6 of 31 active US patents. View full estate on the Emend drug page →
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This patent protects a pharmaceutical composition of a tachykinin receptor antagonist for treating or preventing disorders such as depression, anxiety, inflammatory diseases, and emesis.USPTO title: Pharmaceutical composition of a tachykinin receptor antagonist
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This patent protects a pharmaceutical composition of a tachykinin receptor antagonist for treating or preventing disorders such as depression, anxiety, inflammatory diseases, and emesis.USPTO title: Pharmaceutical composition of a tachykinin receptor antagonist
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This patent protects a pharmaceutical composition of a tachykinin receptor antagonist for treating or preventing disorders such as depression, anxiety, inflammatory diseases, and emesis.USPTO title: Pharmaceutical composition of a tachykinin receptor antagonist
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This patent protects a pharmaceutical composition of a tachykinin receptor antagonist for treating or preventing disorders such as depression, anxiety, inflammatory diseases, and emesis.USPTO title: Pharmaceutical composition of a tachykinin receptor antagonist
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This patent protects novel pharmaceutical formulations of aprepitant, including those with dexamethasone sodium phosphate, for parenteral administration to treat emesis caused by cancer chemotherapy.USPTO title: Emulsion formulations of aprepitant
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This patent protects novel oil-in-water emulsion formulations of an NK-1 receptor antagonist for parenteral administration, including intravenous use.USPTO title: Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Sources
- FDA Orange Book — patents listed against Emend (NDA filed 2003)
- Emend drug profile — full patent estate, indications, clinical trials, pricing
- Merck & Co. patent portfolio
- 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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