Generic entry timeline

DEXTROMETHORPHAN HYDROBROMIDE generics — when can they launch?

DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE) · · 4 active US patents · 0 expired

Earliest patent expiry

2026-08-13

expired

Full patent estate to

2036-10-11

complete protection through 2036

FDA approval

1984

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Where DEXTROMETHORPHAN HYDROBROMIDE sits in the generic timeline

All listed Orange Book patents for DEXTROMETHORPHAN HYDROBROMIDE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.

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.

Formulation — 3 patents
Method of Use — 1 patent

FDA U-codes carved out by DEXTROMETHORPHAN HYDROBROMIDE 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-1093`	(no description)

Sample patent estate

Showing 4 of 4 active US patents. View full estate on the DEXTROMETHORPHAN HYDROBROMIDE drug page →

US7659282 Method of Use · expires 2026-08-13

This patent protects pharmaceutical compositions that combine dextromethorphan and quinidine for treating neurological disorders.

USPTO title: Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
US12257218 Formulation · expires 2036-10-11

This patent protects a formulation for oral administration that provides a therapeutic effect for up to 12 hours.

USPTO title: Pharmaceutical formulation
US11278506 Formulation · expires 2036-10-11

This patent protects a formulation for oral administration that provides a therapeutic effect for up to 12 hours.

USPTO title: Pharmaceutical formulation
US12370189 Formulation · expires 2036-10-11

This patent protects a pharmaceutical formulation that includes guaifenesin, naproxen, and at least one additional active ingredient selected from an antitussive, decongestant, or antihistamine.

USPTO title: Pharmaceutical formulation

Sources

FDA Orange Book — patents listed against DEXTROMETHORPHAN HYDROBROMIDE (NDA filed 1984)
DEXTROMETHORPHAN HYDROBROMIDE drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2026 — 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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