Generic entry timeline

Reglan generics — when can they launch?

Reglan (Metoclopramide Hydrochloride) · Hikma · 7 active US patents · 0 expired

Earliest patent expiry

2029-12-22

4 years remaining

Full patent estate to

2038-11-17

complete protection through 2038

FDA approval

1979

Hikma

Where Reglan sits in the generic timeline

Mid-term cliff: earliest active US patent for Reglan expires in 2029 (~4 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

FDA U-codes carved out by Reglan 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-2843`	(no description)

Sample patent estate

Showing 6 of 7 active US patents. View full estate on the Reglan drug page →

US11628150 Method of Use · expires 2029-12-22

This patent protects methods of treating disorders treatable with metoclopramide by administering nasal formulations of the drug.

USPTO title: Nasal formulations of metoclopramide
US12194009 Method of Use · expires 2029-12-22

This patent protects methods of treating disorders treatable with metoclopramide, specifically by administering nasal formulations of the drug.

USPTO title: Nasal formulations of metoclopramide
US11020361 Method of Use · expires 2029-12-22

This patent protects methods of treating disorders treatable with metoclopramide, specifically by administering nasal formulations of the drug.

USPTO title: Nasal formulations of metoclopramide
US12194008 Method of Use · expires 2029-12-22

This patent protects methods of treating disorders treatable with metoclopramide, specifically by administering nasal formulations of the drug.

USPTO title: Nasal formulations of metoclopramide
US11813231 Method of Use · expires 2029-12-22

This patent protects methods of treating disorders treatable with metoclopramide by administering nasal formulations of the drug.

USPTO title: Nasal formulations of metoclopramide
US8334281 Method of Use · expires 2030-05-16

This patent protects methods of treating disorders treatable with metoclopramide by administering nasal formulations of the drug.

USPTO title: Nasal formulations of metoclopramide

Sources

FDA Orange Book — patents listed against Reglan (NDA filed 1979)
Reglan drug profile — full patent estate, indications, clinical trials, pricing
Hikma patent portfolio
Patent cliff 2029 — 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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