Details for Patent: 12,576,072

Which drugs does patent 12,576,072 protect, and when does it expire?

Patent 12,576,072 protects CLENPIQ and is included in one NDA.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 12,576,072

Title:	Liquid pharmaceutical composition
Abstract:	Described are oral, liquid pharmaceutical compositions that include sodium picosulfate, magnesium oxide, citric acid, and malic acid, and methods of making and using such compositions.
Inventor(s):	Bong Gil Nam, Byeung Jun Lee, Shunji Jin
Assignee:	Ferring International Center SA
Application Number:	US17/542,052
Patent Claim Types: see list of patent claims	Use; Composition; Process;

Executive summary: US Patent 12,576,072 covers an oral liquid bowel-cleansing composition built around sodium picosulfate, magnesium oxide, citric acid, and malic acid with a target pH of 4.1 to 5.4 and a defined weight-ratio window among those components. The claims also add stability/impurity limits (including “Substance A” for sodium picosulfate), precipitation control, and specific additive/vehicle embodiments (e.g., sodium hydroxide pH adjuster; edetate disodium, sodium benzoate, and high-intensity sweeteners like acesulfame potassium and sucralose). The patent’s enforcement hook is the combination of (i) formulation composition and ratios, (ii) in-spec pH, (iii) shelf/room-temperature behavior, and (iv) composition-level use claims tied to colon cleansing and pre-procedural preparation (colonoscopy, surgery, colon X-ray).

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US Patent 12,576,072 claims scope for oral liquid colon cleansing composition

Best read (claim-center): The independent claim scope is anchored to a specific oral liquid composition and an internal composition “recipe” defined by pH and weight ratios.

What is being claimed (core elements)

Claim 1 is a composition claim with the following required limitations:

1. Oral, liquid pharmaceutical composition (dosage form: liquid).
2. Prepared by a process comprising preparing a mixture with:
   • citric acid
   • magnesium oxide
   • malic acid
   • sodium picosulfate
   • a pH adjuster
   • purified water
3. Composition must have pH 4.1 to 5.4.
4. Weight ratio constraints among key actives/acids:
   • 0.003 to 0.009 sodium picosulfate : 1 to 3 magnesium oxide : 3.5 to 10.5 citric acid : 0.01 to 13 malic acid
5. Implicitly required: the ratio must hold within the final formulation (not only in intermediate mixtures), and “present” means measurable inclusion in the formulation.

How tight is the ratio window?

The claim uses a multi-dimensional ratio band rather than single concentration limits. Practically, infringement analysis usually reduces to whether a product’s formulation can be normalized to satisfy:

• sodium picosulfate at 0.003–0.009 equivalents relative to magnesium oxide = 1–3
• citric acid scaled relative to magnesium oxide = 3.5–10.5
• malic acid scaled relative to magnesium oxide = 0.01–13

This structure gives flexibility in absolute concentrations so long as the relative proportions remain in-bounds.

Process language: “prepared by a process comprising preparing a mixture…”

The “process comprising” phrasing can create two litigation-relevant interpretations:

• A conventional “made by mixing” step where any manufacturing that includes forming the recited mixture could satisfy the process portion.
• Depending on prosecution history, it may reduce the need to show a particular order, temperature, or sequence, since the claim only specifies “comprising preparing a mixture comprising …”.

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What pH range and weight-ratio boundaries drive infringement for US 12,576,072

Featured snippet answer: Infringement requires pH 4.1–5.4 plus the sodium picosulfate : magnesium oxide : citric acid : malic acid weight-ratio band.

pH adjuster limitation (and how it narrows)

• Claim 3: pH adjuster comprises sodium hydroxide.
• Claim 1 only requires “a pH adjuster,” without specifying the agent; Claim 3 narrows further.

So:

• A product with the same core formulation and pH could infringe Claim 1 even if it uses another base, but it may miss Claim 3.
• If a base other than sodium hydroxide is used, Claim 3 may not read.

Weight ratio: normalization issues in practice

In patent litigation, formulation defendants often argue about how weight ratios are computed (e.g., basis on active form, hydrate status, free vs salt forms). This patent claim’s ratio is expressed using “weight ratio” among named ingredients. The claim does not expressly define:

• whether magnesium oxide refers to a specific grade/hydrate state
• whether acids are quantified as anhydrous acid forms
• whether picosulfate is measured as a specific polymorph or salt form

Those are typical measurement/basis disputes. For infringement, the patentee still has to prove alignment with the claimed ratio window under a defined assay basis.

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Which additional formulation additives are covered (edetate, benzoate, sweeteners)

Featured snippet answer: Dependent claims expand the covered embodiment with sodium hydroxide, disodium edetate, sodium benzoate, and sweeteners like acesulfame potassium and sucralose.

Claim 4–8 (additives)

Dependent claims from Claim 1 add optional components:

• Claim 4: one or more of sweetener and fragrance ingredient
• Claim 5: further comprises acesulfame potassium
• Claim 6: further comprises disodium edetate
• Claim 7: further comprises sodium benzoate
• Claim 8: further comprises sucralose

These are narrow, but they matter because many commercial bowel-prep liquids use multiple flavor/sweetener systems and preservatives. If a product uses the same additive set, the patent’s dependent-claim coverage strengthens.

Claim 9–12 (combinatorial package)

Claim 9 is a second independent composition claim with a more specific list:

• citric acid, magnesium oxide, malic acid, sodium picosulfate
• sodium hydroxide
• disodium edetate
• sodium benzoate
• water
• pH 4.1–5.4
• same ratio window among sodium picosulfate, magnesium oxide, citric acid, malic acid

This claim is “harder” for an accused product to satisfy because it requires a particular additive package, not merely a pH adjuster.

Claim 10–12 add:

• Claim 10: further comprises acesulfame potassium
• Claim 11: further comprises sucralose
• Claim 12: recites the “about” ratio set to a particular proportional point (see next section)

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How do the “about” ratio embodiments narrow or strengthen protection

Featured snippet answer: The patent has a fixed “center-of-gravity” ratio point (about 0.005 : 1.75 : 6 : 4.19) in dependent claims, which can support both infringement and design-around mapping.

Key point ratio claim

• Claim 2 depends from Claim 1 and recites:

  • about 0.005 sodium picosulfate : 1.75 magnesium oxide : 6 citric acid : 4.19 malic acid

• Claim 12 depends from Claim 9 and repeats the same “about” ratio point.

Why this matters legally

A defendant can attempt to avoid Claim 1 by adjusting ratios outside the specified windows. The “about” dependent-claim point can still catch close formulations if:

• their normalized formulation falls within the “about” tolerance.
• “about” is construed broadly enough to overlap their measured formulation.

From a freedom-to-operate standpoint, the safest design-around is moving outside both:

• the global window of Claim 1/9, and
• the likely “about” tolerance around Claim 2/12.

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What stability/impurity limits are claimed: Substance A and precipitation

Featured snippet answer: The patent includes measurable shelf-life constraints at room temperature after 24 months: Substance A ≤ about 2.0 wt% and precipitation ≤ about 5.0 vol%.

Claim 13: Substance A limit

• Requires the composition of Claim 9.
• Substance A related to sodium picosulfate:
  • “4-[(pyridine-2-yl)(4-hydroxyphenyl) methyl]phenyl sodium sulfate”
• Limit:
  • about 2.0 wt.% or less after the composition is left at room temperature for 24 months.

Claim 14: precipitation limit

• Requires the composition of Claim 9.
• Precipitation after:
  • left at room temperature for 24 months
• Limit:
  • precipitation occurs at about 5.0 vol.% or less

Litigation leverage and design-around

These claims can be valuable where a competitor uses a similar pH and ratio but achieves worse stability:

• If their formulation increases degradation to Substance A above the limit or causes precipitation above the limit, they can avoid infringement of these dependent claims even if they still infringe the base composition claims (Claim 9).
• Conversely, a patentee can use stability test data as a clean infringement proof for those dependent claims.

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What method-of-treatment claims cover: colon cleansing and procedure pretreatment

Featured snippet answer: The patent includes method claims for colon cleaning by orally administering the claimed compositions, with procedure-specific subtypes.

Claim 15–17 (dependent method chain from Claim 1)

• Claim 15: method of treatment for cleaning the colon by orally administering an effective amount of composition of Claim 1.
• Claim 16: specifies use cases:
  • pretreatment for colonoscopy
  • pretreatment for surgery
  • pretreatment for surgery colon X-ray
• Claim 17: recites the specific “about” ratio point from Claim 2 within the composition.

Claim 18–20 (dependent method chain from Claim 9)

• Claim 18: method of treatment using composition of Claim 9.
• Claim 19: procedure-specific list same as Claim 16.
• Claim 20: recites the specific “about” ratio point from Claim 12 within the composition.

Practical scope

For enforcement, method claims typically require proving:

• the defendant product matches the formulation claims (especially Claim 1 or Claim 9 depending on the asserted method claim), and
• the defendant’s labeling or actual use corresponds to colon cleansing and the procedural pretreatment context.

Method claims can remain powerful even if a defendant modifies minor formulation components, so long as the independent composition claim is still met.

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How broad is US 12,576,072 relative to typical bowel-prep chemistry

Featured snippet answer: Coverage is not limited to a single named commercial product. It is centered on a particular acid-buffer system + picosulfate + magnesium oxide combination at a defined pH.

Mechanistic commonality vs claim boundaries

Many bowel-cleansing liquids are built around:

• osmotic and/or stimulant laxatives
• acid/base systems to control palatability, stability, or dissolution

US 12,576,072 narrows those general categories by requiring:

• a specific pH window (4.1 to 5.4)
• a defined ratio window among the four named ingredients
• an optional but defined impurity and precipitation profile (dependent on Claim 9)

So competitors using different buffering systems or different active ratios can reduce composition overlap.

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Potential generic/biosimilar entry risk mapping (formulation design-around scenarios)

Featured snippet answer: The entry risk hinges on whether an accused liquid meets the exact pH + ratio + ingredient identity. Shelf-life and impurity claims increase risk if the formulation is intended to be “close” to the patented system.

Scenario A: Same core ingredients, same pH, ratio slightly outside the band

• Likely avoids Claim 1/9 if the ratio is outside the stated window.
• Dependent “about” point claims (2/12) may still be avoided unless “about” overlaps their data.

Scenario B: Same core ingredients, pH in range, ratio in range, but different base or additives

• Could infringe Claim 1 but not necessarily Claim 3 (if no sodium hydroxide) or not Claim 9 (if missing required additives like disodium edetate and sodium benzoate).
• Method claims could still be asserted depending on which composition independent claim is met.

Scenario C: Same core ingredients and ratio, but stability profile differs

• Even if Claim 9 is met, Claims 13–14 provide an additional infringement screen based on room-temperature 24-month outcomes.
• A defendant can try to improve stability (or worsen to avoid claims) by changing formulation details, but if changes still keep Claim 9 met and do not exceed impurity/precipitation thresholds, the dependent claims remain in reach.

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What the claim set suggests about commercial formulation positioning

Featured snippet answer: The patent targets a liquid bowel-prep that is palatable and shelf-stable, with a defined buffer range and controlled degradation/precipitation.

From a commercial R&D standpoint, the combination of:

• pH target (4.1–5.4),
• magnesium oxide plus dual acids (citric and malic),
• sodium picosulfate,
• and defined additive package (Claim 9) indicates the patentee’s formulation is intended for long room-temperature shelf life with controlled degradation (Substance A) and minimized precipitation.

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Key Takeaways

1. US 12,576,072 is formulation-centric: oral liquid colon-cleansing compositions with a required pH of 4.1–5.4 and a four-component weight-ratio window (sodium picosulfate, magnesium oxide, citric acid, malic acid).
2. Claim 1 is broad to the extent it only requires a pH adjuster (not specifically sodium hydroxide) but is tight on core ingredient identity, pH, and ratios.
3. Claim 9 is a tighter “package” claim that requires specific additives: sodium hydroxide, disodium edetate, and sodium benzoate, plus the same pH and ratio constraints.
4. Claims 13–14 add enforcement value through measured stability limits after 24 months at room temperature: Substance A ≤ about 2.0 wt% and precipitation ≤ about 5.0 vol%.
5. Method claims (15–20) expand use coverage for colon cleansing and pretreatment for colonoscopy, surgery, and colon X-ray, tethered to administering the claimed compositions.

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FAQs

1. What pH range is required by US 12,576,072 for the oral liquid bowel-cleansing composition?
pH must be 4.1 to 5.4.

2. What are the key ingredients that must be present in the claimed composition?
Sodium picosulfate, magnesium oxide, citric acid, malic acid, plus purified water and a pH adjuster (with sodium hydroxide specifically required in Claim 3 and Claim 9).

3. What impurity metric does the patent claim for sodium picosulfate degradation?
Substance A (4-[(pyridine-2-yl)(4-hydroxyphenyl)methyl]phenyl sodium sulfate) must be about 2.0 wt.% or less after 24 months at room temperature (Claim 13).

4. What precipitation threshold is claimed for long-term room-temperature stability?
Precipitation must be about 5.0 vol.% or less after 24 months at room temperature (Claim 14), in the Claim 9 formulation.

5. Does the patent cover methods for colonoscopy or other colon-prep procedures?
Yes. Method claims cover colon cleansing by oral administration and include procedure-specific pretreatment for colonoscopy, surgery, and surgery colon X-ray (Claims 16 and 19).

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References

No sources were cited because the prompt provided only the claim text and did not include external bibliographic, Orange Book, prosecution, or litigation records.

Drugs Protected by US Patent 12,576,072

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	12,576,072		Y			FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY

International Family Members for US Patent 12,576,072

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014386903
Canada	2942878
China	106456534
European Patent Office	3120835
Spain	2907324
Japan	2017508815
Japan	6347891