Tussionex Pennkinetic generics — when can they launch?
Tussionex Pennkinetic (CHLORPHENIRAMINE MALEATE) · Bayer · 3 active US patents · 0 expired
Where Tussionex Pennkinetic sits in the generic timeline
Imminent generic cliff: earliest active US patent for Tussionex Pennkinetic expires in 2027 (~1 year 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.
- Formulation — 2 patents
- Method of Use — 1 patent
FDA U-codes carved out by Tussionex Pennkinetic 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-1716 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Tussionex Pennkinetic drug page →
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This patent protects a pharmaceutical composition that combines a non-steroidal anti-inflammatory drug, a decongestant, and an antihistamine for treating rhinitis and cold-like symptoms.USPTO title: Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines
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This patent protects pharmaceutical tablets that combine a tri-oxygen-containing active agent with a second active ingredient for oral administration.USPTO title: Oral dosage forms for oxygen-containing active agents and oxyl-containing polymer
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This patent protects a pharmaceutical tablet for oral administration that includes a tri-oxy active agent and a release rate controlling non-ionic oxyl-containing hydrophilic polymer.USPTO title: Oral dosage forms for oxygen containing active agents and oxyl-containing polymers
Sources
- FDA Orange Book — patents listed against Tussionex Pennkinetic (NDA filed 1950)
- Tussionex Pennkinetic drug profile — full patent estate, indications, clinical trials, pricing
- Bayer patent portfolio
- Patent cliff 2027 — 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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