LEUPROLIDE ACETATE generics — when can they launch?
LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) · · 19 active US patents · 0 expired
Where LEUPROLIDE ACETATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for LEUPROLIDE ACETATE expires in 2028 (~2 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.
- Composition of Matter — 10 patents
- Method of Use — 8 patents
- Formulation — 1 patent
FDA U-codes carved out by LEUPROLIDE ACETATE 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-3611 | (no description) |
U-4001 | (no description) |
U-1666 | (no description) |
Sample patent estate
Showing 6 of 19 active US patents. View full estate on the LEUPROLIDE ACETATE drug page →
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This patent protects a sustained-release composition containing a water-soluble physiologically active peptide, such as leuprolide acetate, dispersed in a lactic acid polymer microcapsule.USPTO title: Sustained-release composition and method for producing the same
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This patent protects a sustained-release composition containing a water-soluble physiologically active peptide, such as leuprolide acetate, dispersed in a lactic acid polymer microcapsule.USPTO title: Sustained-release composition and method for producing the same
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This patent protects a sustained-release composition containing a water-soluble physiologically active peptide, such as leuprolide acetate, dispersed in a lactic acid polymer microcapsule.USPTO title: Sustained-release composition and method for producing the same
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This patent protects a sustained-release composition containing a water-soluble physiologically active peptide, such as leuprolide acetate, dispersed in a lactic acid polymer microcapsule.USPTO title: Sustained-release composition and method for producing the same
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This patent protects systems and methods for mixing contents between at least two syringes, including a syringe coupler with a convertible valve member.USPTO title: Systems and methods for mixing syringe valve assemblies
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This patent protects systems and methods for mixing contents between at least two syringes, including a syringe coupler with a convertible valve member.USPTO title: Systems and methods for mixing syringe valve assemblies
Sources
- FDA Orange Book — patents listed against LEUPROLIDE ACETATE (NDA filed 1985)
- LEUPROLIDE ACETATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2028 — 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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