Otezla generics — when can they launch?
Otezla (APREMILAST) · Amgen · 23 active US patents · 0 expired
Where Otezla sits in the generic timeline
Imminent generic cliff: earliest active US patent for Otezla 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.
- Other — 9 patents
- Method of Use — 9 patents
- Composition of Matter — 4 patents
- Formulation — 1 patent
FDA U-codes carved out by Otezla 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-2659 | (no description) |
U-2232 | (no description) |
U-2403 | (no description) |
U-1858 | (no description) |
U-4264 | (no description) |
Sample patent estate
Showing 6 of 23 active US patents. View full estate on the Otezla drug page →
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This patent protects the (+)-enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione and methods of synthesizing and using it.USPTO title: (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
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This patent protects the (+)-enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione and methods of synthesizing and using it.USPTO title: (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
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This patent protects the (+)-enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione and methods of synthesizing and using it.USPTO title: (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
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This patent protects the (+)-enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione and methods of synthesizing and using it.USPTO title: (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
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This patent protects a specific form of a compound, (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, and methods of making and using it.USPTO title: (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
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This patent protects a specific form of a compound, (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, and methods of using it to treat certain disorders.USPTO title: (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
Sources
- FDA Orange Book — patents listed against Otezla (NDA filed 2014)
- Otezla drug profile — full patent estate, indications, clinical trials, pricing
- Amgen patent portfolio
- 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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