Bupivacaine Hydrochloride And Epinephrine generics — when can they launch?
Bupivacaine Hydrochloride And Epinephrine (BUPIVACAINE) · Innocoll · 108 active US patents · 0 expired
Where Bupivacaine Hydrochloride And Epinephrine sits in the generic timeline
Long-dated protection: earliest active US patent for Bupivacaine Hydrochloride And Epinephrine extends to 2034 (~8 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 — 93 patents
- Formulation — 15 patents
FDA U-codes carved out by Bupivacaine Hydrochloride And Epinephrine 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-3118 | (no description) |
U-3417 | (no description) |
U-3724 | (no description) |
U-3250 | (no description) |
U-4184 | (no description) |
U-3380 | (no description) |
U-3346 | (no description) |
U-4037 | (no description) |
U-3182 | (no description) |
U-4033 | (no description) |
U-3439 | (no description) |
U-3839 | (no description) |
U-3840 | (no description) |
U-4148 | (no description) |
U-3841 | (no description) |
U-4152 | (no description) |
Sample patent estate
Showing 6 of 108 active US patents. View full estate on the Bupivacaine Hydrochloride And Epinephrine drug page →
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This patent protects compositions of a biodegradable polyorthoester polymer, an aprotic solvent, and a drug, which can modulate the release of the drug.USPTO title: Compositions of a polyorthoester and an aprotic solvent
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This patent describes delivery systems and compositions made of a biodegradable polymer, an aprotic solvent, and a drug, which can modulate the release of the drug.USPTO title: Compositions of a polyorthoester and an aprotic solvent
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This patent describes delivery systems and compositions made of a biodegradable polymer, an aprotic solvent, and a drug, which can modulate the release of the drug.USPTO title: Compositions of a polyorthoester and an aprotic solvent
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This patent protects compositions of a biodegradable polyorthoester polymer, an aprotic solvent, and a drug, which can modulate the release of the drug.USPTO title: Compositions of a polyorthoester and an aprotic solvent
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This patent describes delivery systems and compositions made of a biodegradable polymer and an aprotic solvent that can modulate the release of a drug.USPTO title: Compositions of a polyorthoester and an aprotic solvent
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This patent protects compositions of a biodegradable polyorthoester polymer, an aprotic solvent, and a drug, which can modulate the release of the drug.USPTO title: Compositions of a polyorthoester and an aprotic solvent
Sources
- FDA Orange Book — patents listed against Bupivacaine Hydrochloride And Epinephrine (NDA filed 1972)
- Bupivacaine Hydrochloride And Epinephrine drug profile — full patent estate, indications, clinical trials, pricing
- Innocoll patent portfolio
- Patent cliff 2034 — 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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