COCAINE HYDROCHLORIDE generics — when can they launch?
COCAINE HYDROCHLORIDE (COCAINE HYDROCHLORIDE) · · 23 active US patents · 0 expired
Where COCAINE HYDROCHLORIDE sits in the generic timeline
Long-dated protection: earliest active US patent for COCAINE HYDROCHLORIDE extends to 2037 (~11 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 — 19 patents
- Formulation — 4 patents
FDA U-codes carved out by COCAINE HYDROCHLORIDE 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-2478 | (no description) |
U-2225 | (no description) |
U-3014 | (no description) |
U-3680 | (no description) |
U-2226 | (no description) |
U-2329 | (no description) |
U-2479 | (no description) |
Sample patent estate
Showing 6 of 23 active US patents. View full estate on the COCAINE HYDROCHLORIDE drug page →
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This patent protects novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those compositions.USPTO title: Pharmaceutical compositions and methods of using the same
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This patent protects novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those compositions.USPTO title: Pharmaceutical compositions and methods of using the same
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This patent protects novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those compositions.USPTO title: Pharmaceutical compositions and methods of using the same
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This patent protects novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those compositions.USPTO title: Pharmaceutical compositions and methods of using the same
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This patent protects novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those compositions.USPTO title: Pharmaceutical compositions and methods of using the same
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This patent protects novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those compositions.USPTO title: Pharmaceutical compositions and methods of using the same
Sources
- FDA Orange Book — patents listed against COCAINE HYDROCHLORIDE (NDA filed 2017)
- COCAINE HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2037 — 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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