Austedo generics — when can they launch?
Austedo (DEUTETRABENAZINE) · Teva · 252 active US patents · 0 expired
Where Austedo sits in the generic timeline
Mid-term cliff: earliest active US patent for Austedo expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 122 patents
- Method of Use — 96 patents
- Formulation — 23 patents
- Composition of Matter — 11 patents
FDA U-codes carved out by Austedo 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-3055 | (no description) |
U-1995 | (no description) |
Sample patent estate
Showing 6 of 252 active US patents. View full estate on the Austedo drug page →
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This patent protects new benzoquinoline inhibitors of the vesicular monoamine transporter 2 (VMAT2) and their pharmaceutical compositions.USPTO title: Benzoquinoline inhibitors of vesicular monoamine transporter 2
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This patent protects new benzoquinoline inhibitors of the vesicular monoamine transporter 2 (VMAT2) and their pharmaceutical compositions.USPTO title: Benzoquinoline inhibitors of vesicular monoamine transporter 2
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This patent protects new benzoquinoline inhibitors of the vesicular monoamine transporter 2 (VMAT2) and their pharmaceutical compositions.USPTO title: Benzoquinoline inhibitors of vesicular monoamine transporter 2
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This patent protects new benzoquinoline inhibitors of the vesicular monoamine transporter 2 (VMAT2) and their pharmaceutical compositions.USPTO title: Benzoquinoline inhibitors of vesicular monoamine transporter 2
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This patent protects new benzoquinoline inhibitors of the vesicular monoamine transporter 2 (VMAT2) and their pharmaceutical compositions.USPTO title: Benzoquinoline inhibitors of vesicular monoamine transporter 2
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This patent protects new benzoquinoline inhibitors of the vesicular monoamine transporter 2 (VMAT2) and their pharmaceutical compositions.USPTO title: Benzoquinoline inhibitors of vesicular monoamine transporter 2
Sources
- FDA Orange Book — patents listed against Austedo (NDA filed 2017)
- Austedo drug profile — full patent estate, indications, clinical trials, pricing
- Teva patent portfolio
- Patent cliff 2031 — 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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