Skyclarys generics — when can they launch?
Skyclarys (OMAVELOXOLONE) · Biogen Us · 7 active US patents · 0 expired
Where Skyclarys sits in the generic timeline
Imminent generic cliff: earliest active US patent for Skyclarys expires in 2029 (~3 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.
- Composition of Matter — 4 patents
- Method of Use — 2 patents
- Formulation — 1 patent
FDA U-codes carved out by Skyclarys 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-3862 | (no description) |
U-3552 | (no description) |
Sample patent estate
Showing 6 of 7 active US patents. View full estate on the Skyclarys drug page →
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This patent protects novel oleanolic acid derivatives and their uses, including pharmaceutical compositions and methods of using the compounds.USPTO title: Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
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This patent protects novel oleanolic acid derivatives and their uses, including pharmaceutical compositions and methods of using the compounds.USPTO title: Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at c-17
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This patent protects novel oleanolic acid derivatives, including their pharmaceutical compositions and methods of use, invented by Reata Pharmaceuticals Inc.USPTO title: Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
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This patent protects novel oleanolic acid derivatives and their use in pharmaceutical compositions, kits, and articles of manufacture.USPTO title: Antioxidant inflammation modulators: oleanolic acid derivatives with amino acid and other modifications at C-17
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This patent protects novel oleanolic acid derivatives, including their pharmaceutical compositions and methods of use, as invented by Reata Pharmaceuticals Inc.USPTO title: Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
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This patent protects the compound N-((4aS,6aR,6bS,8aR,12aS,14aR,14bS)-11-cyano-2,2,6a,6b,9,9,12a-heptamethyl-10,14-dioxo-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,12a,14,14a,14b-octadecahydropicen-USPTO title: 2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof
Sources
- FDA Orange Book — patents listed against Skyclarys (NDA filed 2023)
- Skyclarys drug profile — full patent estate, indications, clinical trials, pricing
- Biogen Us patent portfolio
- Patent cliff 2029 — 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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