Differin generics — when can they launch?
Differin (ADAPALENE) · Galderma Labs Lp · 14 active US patents · 0 expired
Where Differin sits in the generic timeline
All listed Orange Book patents for Differin 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 — 12 patents
- Formulation — 2 patents
FDA U-codes carved out by Differin 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-1078 | (no description) |
U-3713 | (no description) |
Sample patent estate
Showing 6 of 14 active US patents. View full estate on the Differin drug page →
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This patent protects a cosmetic or dermatological composition for topical application that contains a naphthoic acid compound and a polyurethane polymer.USPTO title: Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
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This patent protects a method of using a composition containing naphthoic acid compounds and polyurethane polymers for treating acne.USPTO title: Cosmetic/dermatological compositions comprising naphtholic acid compounds and polyurethane polymers
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This patent protects the use of adapalene in combination with benzoyl peroxide for reducing the number of acne lesions through daily topical application.USPTO title: Combinations of adapalene and benzoyl peroxide for treating acne lesions
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This patent protects the use of adapalene in combination with benzoyl peroxide for reducing the number of acne lesions through daily topical application.USPTO title: Combinations of adapalene and benzoyl peroxide for treating acne lesions
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This patent protects a daily topical regimen using a combination of adapalene and benzoyl peroxide to treat and reduce acne lesions.USPTO title: Combination/association of adapalene and benzoyl peroxide for treating acne lesions
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This patent protects a cosmetic or dermatological composition for topical application that contains a naphthoic acid compound and a polyurethane polymer.USPTO title: Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Sources
- FDA Orange Book — patents listed against Differin (NDA filed 1996)
- Differin drug profile — full patent estate, indications, clinical trials, pricing
- Galderma Labs Lp 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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