TESTOSTERONE ENANTHATE generics — when can they launch?
TESTOSTERONE ENANTHATE (TESTOSTERONE ENANTHATE) · · 51 active US patents · 18 expired
Where TESTOSTERONE ENANTHATE sits in the generic timeline
All listed Orange Book patents for TESTOSTERONE ENANTHATE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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.
- Formulation — 33 patents
- Method of Use — 18 patents
FDA U-codes carved out by TESTOSTERONE ENANTHATE 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-2418 | (no description) |
Sample patent estate
Showing 6 of 51 active US patents. View full estate on the TESTOSTERONE ENANTHATE drug page →
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This patent protects a jet injector that uses a prefilled syringe to deliver a medicament, such as testosterone enanthate, at a pressure of between 80 and 1000 p.s.i.USPTO title: Prefilled syringe jet injector
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This patent protects a jet injector that uses a prefilled syringe to deliver a medicament, such as testosterone enanthate, at a pressure of between 80 and 1000 p.s.i.USPTO title: Prefilled syringe jet injector
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This patent protects a jet injector that uses a prefilled syringe to deliver a medicament, such as testosterone enanthate, at a pressure of between 80 and 1000 p.s.i.USPTO title: Prefilled syringe jet injector
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This patent protects a hazardous agent injection system, specifically designed for use with a powered injector.USPTO title: Hazardous agent injection system
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This patent protects a hazardous agent injection system, specifically designed for use with a powered injector.USPTO title: Hazardous agent injection system
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This patent protects a hazardous agent injection system, specifically designed for use with a powered injector.USPTO title: Hazardous agent injection system
Sources
- FDA Orange Book — patents listed against TESTOSTERONE ENANTHATE (NDA filed 1953)
- TESTOSTERONE ENANTHATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2026 — 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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