ACETAMINOPHEN generics — when can they launch?
ACETAMINOPHEN (ACETAMINOPHEN) · · 45 active US patents · 0 expired
Where ACETAMINOPHEN sits in the generic timeline
Imminent generic cliff: earliest active US patent for ACETAMINOPHEN 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 — 19 patents
- Formulation — 13 patents
- Composition of Matter — 9 patents
- Other — 4 patents
FDA U-codes carved out by ACETAMINOPHEN 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-1498 | (no description) |
U-2261 | (no description) |
U-2262 | (no description) |
U-2263 | (no description) |
U-1499 | (no description) |
U-2249 | (no description) |
U-4306 | (no description) |
U-3744 | (no description) |
U-3553 | (no description) |
Sample patent estate
Showing 6 of 45 active US patents. View full estate on the ACETAMINOPHEN drug page →
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This patent protects a controlled-release oral dosage form that delivers a pharmacologically active agent primarily to the upper gastrointestinal tract while restricting delivery to the lower tract.USPTO title: Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
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This patent protects a method for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for pain and/or fever treatment.USPTO title: Reduced dose intravenous acetaminophen
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This patent protects a method for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for pain and/or fever treatment.USPTO title: Reduced dose intravenous acetaminophen
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This patent protects a method for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for pain and/or fever treatment.USPTO title: Reduced dose intravenous acetaminophen
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This patent protects a dosage form that delivers a combination of acetaminophen and an opioid to the upper gastrointestinal tract of a mammal for an extended period of time.USPTO title: Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
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This patent protects a dosage form that delivers acetaminophen and an opioid to a mammal's upper gastrointestinal tract for an extended period of time.USPTO title: Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Sources
- FDA Orange Book — patents listed against ACETAMINOPHEN (NDA filed 1968)
- ACETAMINOPHEN drug profile — full patent estate, indications, clinical trials, pricing
- 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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