Myrbetriq generics — when can they launch?
Myrbetriq (MIRABEGRON) · Apgdi · 22 active US patents · 0 expired
Where Myrbetriq sits in the generic timeline
Imminent generic cliff: earliest active US patent for Myrbetriq 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 — 11 patents
- Method of Use — 9 patents
- Formulation — 2 patents
FDA U-codes carved out by Myrbetriq 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-2300 | (no description) |
U-2996 | (no description) |
U-3670 | (no description) |
U-3108 | (no description) |
Sample patent estate
Showing 6 of 22 active US patents. View full estate on the Myrbetriq drug page →
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This patent protects a pharmaceutical composition containing two active ingredients for treating overactive bladder symptoms.USPTO title: Pharmaceutical composition for treating overactive bladder
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This patent protects a pharmaceutical composition containing two active ingredients for treating overactive bladder symptoms.USPTO title: Pharmaceutical composition for treating overactive bladder
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Astellas Pharma Inc. has a patent for a pharmaceutical composition that treats overactive bladder symptoms, including urinary urgency, pollakiuria, and urinary incontinence.USPTO title: Pharmaceutical composition for treating overactive bladder
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Astellas Pharma Inc. has a patent for a pharmaceutical composition that treats overactive bladder symptoms, including urinary urgency, pollakiuria, and urinary incontinence.USPTO title: Pharmaceutical composition for treating overactive bladder
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A pharmaceutical composition for modified release of (R)-2-(2-aminothiazol-4-yl)-4â²-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide or a salt thereof is disclosed.USPTO title: Pharmaceutical composition for modified release
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This patent protects a pharmaceutical composition for modified release that includes a specific active ingredient and additives to enhance water penetration and a hydrogel-forming polymer.USPTO title: Pharmaceutical composition for modified release
Sources
- FDA Orange Book — patents listed against Myrbetriq (NDA filed 2012)
- Myrbetriq drug profile — full patent estate, indications, clinical trials, pricing
- Apgdi 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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