Prograf generics — when can they launch?
Prograf (TACROLIMUS) · Astellas Pharma · 30 active US patents · 0 expired
Where Prograf sits in the generic timeline
Imminent generic cliff: earliest active US patent for Prograf 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.
- Method of Use — 18 patents
- Formulation — 12 patents
FDA U-codes carved out by Prograf 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-2677 | (no description) |
U-2678 | (no description) |
U-1752 | (no description) |
Sample patent estate
Showing 6 of 30 active US patents. View full estate on the Prograf drug page →
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This patent protects an extended release oral dosage form of tacrolimus for once daily immunosuppressive treatment of transplant patients.USPTO title: Tacrolimus for improved treatment of transplant patients
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This patent protects a stable pharmaceutical composition of tacrolimus, a solid dispersion in a vehicle with a stabilizing agent that prevents degradation.USPTO title: Stabilized tacrolimus composition
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This patent protects an extended release oral dosage form of tacrolimus for once daily immunosuppressive treatment of transplant patients.USPTO title: Tacrolimus for improved treatment of transplant patients
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This patent protects a stable pharmaceutical composition of tacrolimus, a solid dispersion in a vehicle with a stabilizing agent that prevents degradation.USPTO title: Stabilized tacrolimus composition
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This patent protects an extended release oral dosage form of tacrolimus for once daily immunosuppressive treatment of transplant patients.USPTO title: Tacrolimus for improved treatment of transplant patients
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This patent protects an extended release oral dosage form of tacrolimus for once daily immunosuppressive treatment of transplant patients.USPTO title: Tacrolimus for improved treatment of transplant patients
Sources
- FDA Orange Book — patents listed against Prograf (NDA filed 1994)
- Prograf drug profile — full patent estate, indications, clinical trials, pricing
- Astellas Pharma 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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