Generic entry timeline

Nimotop generics — when can they launch?

Nimotop (NIMODIPINE) · · 6 active US patents · 0 expired

Earliest patent expiry

2038-04-16

12 years remaining

Full patent estate to

2038-04-16

complete protection through 2038

FDA approval

1988

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Where Nimotop sits in the generic timeline

Long-dated protection: earliest active US patent for Nimotop extends to 2038 (~12 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

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 — 5 patents
Formulation — 1 patent

FDA U-codes carved out by Nimotop 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-2804`	(no description)

Sample patent estate

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

US11207306 Method of Use · expires 2038-04-16

This patent protects non-aqueous liquid compositions of nimodipine, specifically for reducing ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms.

USPTO title: Non-aqueous liquid nimodipine compositions
US11413277 Method of Use · expires 2038-04-16

This patent protects non-aqueous liquid compositions of nimodipine that have improved stability and methods of using them to reduce ischemic deficits in patients with subarachnoid hemorrhage.

USPTO title: Non-aqueous liquid nimodipine compositions
US12186308 Method of Use · expires 2038-04-16

This patent protects non-aqueous liquid compositions of nimodipine that have improved stability and methods of using them to reduce ischemic deficits in patients with subarachnoid hemorrhage.

USPTO title: Non-aqueous liquid nimodipine compositions
US10342787 Method of Use · expires 2038-04-16

This patent protects non-aqueous liquid compositions of nimodipine that have improved stability and methods of using them to reduce ischemic deficits in patients with subarachnoid hemorrhage.

USPTO title: Non-aqueous liquid nimodipine compositions
US10576070 Method of Use · expires 2038-04-16

This patent protects non-aqueous liquid compositions of nimodipine that have improved stability and methods of using them to reduce ischemic deficits in patients with subarachnoid hemorrhage.

USPTO title: Non-aqueous liquid nimodipine compositions
US11806338 Formulation · expires 2038-04-16

This patent protects non-aqueous liquid compositions of nimodipine, a drug also known as Nimotop, with improved stability.

USPTO title: Non-aqueous liquid nimodipine compositions

Sources

FDA Orange Book — patents listed against Nimotop (NDA filed 1988)
Nimotop drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2038 — 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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