Androgel generics — when can they launch?
Androgel (TESTOSTERONE) · Besins Hlthcare · 38 active US patents · 0 expired
Where Androgel sits in the generic timeline
All listed Orange Book patents for Androgel 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.
- Method of Use — 23 patents
- Formulation — 15 patents
FDA U-codes carved out by Androgel 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-1390 | (no description) |
U-1103 | (no description) |
U-1386 | (no description) |
U-1563 | (no description) |
U-1531 | (no description) |
U-1616 | (no description) |
U-4366 | (no description) |
Sample patent estate
Showing 6 of 38 active US patents. View full estate on the Androgel drug page →
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This patent protects a method and composition for transdermal drug delivery, including a specific way to administer the composition to a subject.USPTO title: Method and composition for transdermal drug delivery
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This patent protects a method and composition for transdermal drug delivery, including a specific way to administer the composition to a subject.USPTO title: Method and composition for transdermal drug delivery
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This patent protects an improved transdermal hydroalcoholic testosterone gel formulation and its methods of use.USPTO title: Testosterone gel and method of use
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This patent protects an improved transdermal hydroalcoholic testosterone gel formulation and methods of its use.USPTO title: Testosterone gel and method of use
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This patent protects an improved transdermal hydroalcoholic testosterone gel formulation and its methods of use.USPTO title: Testosterone gel and method of use
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This patent protects an improved transdermal hydroalcoholic testosterone gel formulation and its methods of use.USPTO title: Testosterone gel and method of use
Sources
- FDA Orange Book — patents listed against Androgel (NDA filed 1972)
- Androgel drug profile — full patent estate, indications, clinical trials, pricing
- Besins Hlthcare patent portfolio
- 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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