Testosterone Cypionate generics — when can they launch?
Testosterone Cypionate (Testosterone Cypionate) · Azurity · 3 active US patents · 0 expired
Where Testosterone Cypionate sits in the generic timeline
Long-dated protection: earliest active US patent for Testosterone Cypionate extends to 2039 (~13 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.
- Formulation — 3 patents
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Testosterone Cypionate drug page →
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This patent protects stable pharmaceutical compositions of testosterone or its esters, including a specific process for stabilizing them.USPTO title: Pharmaceutical compositions of testosterone
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This patent protects stable pharmaceutical compositions of testosterone or its esters, including a specific oil vehicle and stabilizing amount of benzyl alcohol.USPTO title: Pharmaceutical compositions of testosterone
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This patent protects stable pharmaceutical compositions of testosterone or its esters, including a specific process for stabilizing them through aging.USPTO title: Pharmaceutical compositions of testosterone
Sources
- FDA Orange Book — patents listed against Testosterone Cypionate (NDA filed 1978)
- Testosterone Cypionate drug profile — full patent estate, indications, clinical trials, pricing
- Azurity patent portfolio
- Patent cliff 2039 — 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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