Merrem generics — when can they launch?
Merrem (Meropenem) · Pfizer · 10 active US patents · 0 expired
Where Merrem sits in the generic timeline
Mid-term cliff: earliest active US patent for Merrem 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 — 7 patents
- Composition of Matter — 2 patents
- Formulation — 1 patent
FDA U-codes carved out by Merrem 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-2120 | (no description) |
U-2490 | (no description) |
U-3128 | (no description) |
U-3421 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Merrem drug page →
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This patent protects cyclic boronic acid ester derivatives and their use as therapeutic agents.USPTO title: Cyclic boronic acid ester derivatives and therapeutic uses thereof
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This patent protects pharmaceutical compositions comprising cyclic boronic acid ester derivatives, which are used as therapeutic agents.USPTO title: Pharmaceutical compositions comprising cyclic boronic acid ester derivatives
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This patent protects a method of treating bacterial infections by administering a combination of a cyclic boronic acid ester compound and the carbapenem antibacterial agent Biapenem.USPTO title: Cyclic boronic acid ester derivatives and therapeutic uses thereof
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This patent protects the use of cyclic boronic acid ester derivatives as therapeutic agents.USPTO title: Therapeutic uses of pharmaceutical compositions comprising cyclic boronic acid ester derivatives
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This patent protects a method of treating bacterial infections by administering a cyclic boronic acid ester compound in combination with a carbapenem antibacterial agent like Biapenem.USPTO title: Cyclic boronic acid ester derivatives and therapeutic uses thereof
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This patent protects the use of cyclic boronic acid ester derivatives as therapeutic agents.USPTO title: Therapeutic uses of pharmaceutical compositions comprising cyclic boronic acid ester derivatives
Sources
- FDA Orange Book — patents listed against Merrem (NDA filed 1996)
- Merrem drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer 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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