Heparin Sodium In Plastic Container generics — when can they launch?
Heparin Sodium In Plastic Container (Heparin Sodium) · Fresenius Kabi · 2 active US patents · 2 expired
Where Heparin Sodium In Plastic Container sits in the generic timeline
Long-dated protection: earliest active US patent for Heparin Sodium In Plastic Container extends to 2042 (~16 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
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Heparin Sodium In Plastic Container drug page →
-
USPTO title: Synthesis of taurolidine, purity profiles and polymorphs
-
USPTO title: Synthesis of taurolidine, purity profiles and polymorphs
Sources
- FDA Orange Book — patents listed against Heparin Sodium In Plastic Container (NDA filed 1939)
- Heparin Sodium In Plastic Container drug profile — full patent estate, indications, clinical trials, pricing
- Fresenius Kabi patent portfolio
- Patent cliff 2042 — 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.
Get generic entry alerts
Free Pharma CI alerts on Heparin Sodium In Plastic Container — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →