PITAVASTATIN MAGNESIUM generics — when can they launch?
PITAVASTATIN MAGNESIUM (PITAVASTATIN MAGNESIUM) · · 3 active US patents · 0 expired
Where PITAVASTATIN MAGNESIUM sits in the generic timeline
Mid-term cliff: earliest active US patent for PITAVASTATIN MAGNESIUM expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 3 patents
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the PITAVASTATIN MAGNESIUM drug page →
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This patent protects a method for preparing pitavastatin and its pharmaceutical acceptable salts, specifically salts of magnesium, zinc, potassium, strontium, and barium.USPTO title: Method for preparation of pitavastatin and pharmaceutical acceptable salts thereof
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This patent protects a method for preparing pitavastatin and its pharmaceutical acceptable salts, specifically salts of magnesium, zinc, potassium, strontium, and barium.USPTO title: Method for preparation of pitavastatin and pharmaceutical acceptable salts thereof
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This patent protects a method for preparing pitavastatin and its pharmaceutical acceptable salts, specifically salts of magnesium, zinc, potassium, strontium, and barium.USPTO title: Method for preparation of pitavastatin and pharmaceutical acceptable salts thereof
Sources
- FDA Orange Book — patents listed against PITAVASTATIN MAGNESIUM (NDA filed 2017)
- PITAVASTATIN MAGNESIUM drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2031 — 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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