SODIUM PHOSPHATE, DIBASIC, ANHYDROUS generics — when can they launch?
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (SODIUM PHOSPHATE, DIBASIC, ANHYDROUS) · · 1 active US patent · 0 expired
Where SODIUM PHOSPHATE, DIBASIC, ANHYDROUS sits in the generic timeline
Imminent generic cliff: earliest active US patent for SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 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.
- Composition of Matter — 1 patent
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the SODIUM PHOSPHATE, DIBASIC, ANHYDROUS drug page →
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This patent protects novel colonic purgative compositions in a solid dosage form that improve patient tolerance and bowel cleansing quality.USPTO title: Colonic purgative composition with soluble binding agent
Sources
- FDA Orange Book — patents listed against SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (NDA filed 1957)
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS drug profile — full patent estate, indications, clinical trials, pricing
- 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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