NITROGLYCERIN generics — when can they launch?
NITROGLYCERIN (NITROGLYCERIN) · · 2 active US patents · 0 expired
Where NITROGLYCERIN sits in the generic timeline
Imminent generic cliff: earliest active US patent for NITROGLYCERIN expires in 2029 (~3 years 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 — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by NITROGLYCERIN 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-2223 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the NITROGLYCERIN drug page →
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This patent protects a pharmaceutical preparation containing glyceryl trinitrate that has improved storage stability due to the addition of a proton-absorbing substance.USPTO title: Long-term stable pharmaceutical preparation containing the active ingredient glyceryl trinitrate
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This patent protects a stabilized pharmaceutical preparation containing glyceryl trinitrate for oromucosal or oral administration with specific composition requirements.USPTO title: Stabilized granules containing glyceryl trinitrate
Sources
- FDA Orange Book — patents listed against NITROGLYCERIN (NDA filed 1981)
- NITROGLYCERIN drug profile — full patent estate, indications, clinical trials, pricing
- 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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