Litfulo generics — when can they launch?
Litfulo (Ritlecitinib Tosylate) · Pfizer · 3 active US patents · 0 expired
Where Litfulo sits in the generic timeline
Long-dated protection: earliest active US patent for Litfulo extends to 2034 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 2 patents
- Method of Use — 1 patent
FDA U-codes carved out by Litfulo 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-3994 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Litfulo drug page →
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This patent protects a class of pyrrolo[2,3-d]pyrimidinyl and pyrrolo[2,3-d]pyridinyl acrylamides and their analogues, useful for inhibiting Janus Kinase (JAK).USPTO title: Pyrrolo[2,3-d]pyrimidinyl, pyrrolo[2,3-b]pyrazinyl and pyrrolo[2,3-d]pyridinyl acrylamides
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This patent protects a method for treating alopecia using certain pyrrolo[2,3-d]pyrimidinyl acrylamides.USPTO title: Pyrrolo[2,3-d]pyrimidinyl, pyrrolo[2,3-b]pyrazinyl and pyrrolo[2,3-d]pyridinyl acrylamides
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This patent protects a novel crystalline form of a p-toluenesulfonic acid salt of the compound 1-((2S,5R)-5-((7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-2-methylpiperidin-1-yl)prop-2-en-1-one.USPTO title: Pyrrolo[2,3-d]pyrimidine tosylate salt, crystalline form thereof and manufacturing process and intermediates thereto
Sources
- FDA Orange Book — patents listed against Litfulo (NDA filed 2023)
- Litfulo drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2034 — 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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