Renacidin generics — when can they launch?
Renacidin (CITRIC ACID) · Baxter · 10 active US patents · 0 expired
Where Renacidin sits in the generic timeline
Imminent generic cliff: earliest active US patent for Renacidin 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.
- Method of Use — 5 patents
- Formulation — 4 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Renacidin 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-1 | Treatment of a specific disease/condition (broad) |
U-3261 | (no description) |
U-2162 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Renacidin drug page →
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This patent protects granular compositions of magnesium oxide and citric acid, and their uses in preparing medicaments.USPTO title: Granular compositions of magnesium oxide and citric acid and uses thereof
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This patent protects granular compositions of sodium picosulphate and potassium bicarbonate, and mixtures of these compositions with additional granules of magnesium oxide and citric acid.USPTO title: Granular compositions of sodium picosulphate and potassium bicarbonate and uses thereof
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This patent protects compositions and methods that combine a contraceptive microbicide with an antiviral agent to prevent pregnancy and reduce the risk of spreading sexually transmitted diseases.USPTO title: Compositions and methods for enhancing the efficacy of contraceptive microbicides
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This patent protects compositions and methods that combine a contraceptive microbicide with an antiviral agent in an acidic carrier to enhance their efficacy.USPTO title: Compositions and methods for enhancing the efficacy of contraceptive microbicides
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This patent protects compositions and methods that combine a contraceptive microbicide with an antiviral agent to prevent pregnancy and reduce the risk of spreading sexually transmitted diseases.USPTO title: Compositions and methods for enhancing the efficacy of contraceptive microbicides
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This patent protects compositions and methods for inhibiting inflammation and reducing the risk of spreading sexually transmitted diseases using an alginic acid-based antimicrobial compound.USPTO title: Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound
Sources
- FDA Orange Book — patents listed against Renacidin (NDA filed 1982)
- Renacidin drug profile — full patent estate, indications, clinical trials, pricing
- Baxter patent portfolio
- 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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