Details for Patent: 11,033,498

Which drugs does patent 11,033,498 protect, and when does it expire?

Patent 11,033,498 protects SUTAB and is included in one NDA.

Summary for Patent: 11,033,498

Title:	Solid oral sulfate salt formulations for cleaning a colon and methods of using same
Abstract:	Disclosed herein are solid oral dosage formulations comprising sodium sulfate, magnesium sulfate, and potassium chloride for inducing purgation of the colon of a subject. Furthermore, the disclosed compositions and formulations are useful to cleanse the colon when administered in sufficient quantities. Methods for inducing purgation of the colon and for cleansing the colon are also disclosed.
Inventor(s):	Mark vB. Cleveland, Edmund V. Dennett, Jr., Russell W. Pelham
Assignee:	Chavous David , Azurity Pharmaceuticals Inc
Application Number:	US16/207,800
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,033,498
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

US Patent 11,033,498: Scope, Claims, Expiration, Litigation Risk, and SUTAB Patent Landscape

US Patent No. 11,033,498 protects a split-dose tablet regimen for cleansing the colon using sodium sulfate, magnesium sulfate, and potassium chloride. The patent is directed primarily to the method of administering the product, not to the salt composition in isolation. Its strongest commercial relevance is to SUTAB, the 12-tablet-per-dose bowel-preparation product marketed by Sebela Pharmaceuticals and Braintree Laboratories.

The central claim requires two administrations of the same oral dosage form, each containing approximately 17.75 grams of sodium sulfate, 2.7 grams of magnesium sulfate, and 2.25 grams of potassium chloride, with liquid consumed after each dose within two hours. The dependent claims add tablet count, excipients, water volume, consumption timing, and electrolyte-safety limitations. [1][2]

What drug and product does US Patent 11,033,498 cover?

US 11,033,498 covers a method corresponding closely to the labeled SUTAB regimen.

Product characteristic	Patent claim requirement	SUTAB labeling
Sodium sulfate per dose	About 17.75 g	17.75 g
Magnesium sulfate per dose	About 2.7 g	2.7 g
Potassium chloride per dose	About 2.25 g	2.25 g
Doses	Two	Two
Tablets per dose	At least 6; dependent claim specifies 12	12
Water after each dose	At least about 16 ounces under dependent claims	16 ounces
Timing for liquid	Within two hours; narrower claim within 60 minutes	Label directs consumption during the specified preparation period
Administration format	Oral dosage form; tablet in dependent claims	Tablet
FDA product	SUTAB, NDA 213735	Approved by FDA

Each SUTAB tablet contains approximately 1.479 grams of sodium sulfate, 0.225 grams of magnesium sulfate, and 0.188 grams of potassium chloride. Twelve tablets produce the amounts recited in the patent. [2]

What is the legal scope of claim 1?

Claim 1 is a two-dose method-of-treatment claim with a defined electrolyte composition. It contains four principal limitations:

1. A first dose of the specified colon-cleansing composition.
2. A first liquid volume administered within two hours.
3. A second dose of the same composition.
4. A second liquid volume administered within two hours.

The claim also requires that the composition cleanse the colon.

The claim does not expressly require 12 tablets. It covers any oral dosage form capable of delivering the recited quantities, subject to the other limitations. Claim 2 narrows the dosage form to a tablet, and claims 3 and 4 narrow the first and second doses to at least six tablets and exactly 12 tablets, respectively.

What does "consisting essentially of" mean?

The phrase "consisting essentially of" generally permits additional ingredients but excludes components that materially affect the basic and novel characteristics of the claimed composition.

The basic characteristics likely include:

• The sulfate and potassium electrolyte quantities.
• Oral administration in two doses.
• Colon-cleansing performance.
• The product's tolerability profile, including the absence of clinically significant electrolyte shifts.

An accused product containing ordinary pharmaceutical excipients would not necessarily fall outside claim 1. A formulation with additional active ingredients, materially different electrolyte content, or a different mechanism of bowel cleansing could present a stronger noninfringement position.

Which dependent claims create the greatest infringement exposure?

The highest-risk claims for a SUTAB-type generic are claims 2 through 4 and claims 9 through 12.

Claim	Added limitation	Commercial significance
2	Oral dosage form is a tablet	Captures the marketed tablet format
3	At least six tablets per dose	Covers multi-tablet regimens
4	Twelve tablets per dose	Closely tracks SUTAB labeling
5	Sodium caprylate	Captures a specific excipient option
6	Polyethylene glycol	Captures a PEG-containing formulation
7	Sodium caprylate and PEG	Covers the combination
8	0.1-1.0 g sodium caprylate and 1.6-2.1 g PEG	Narrows the excipient ranges
9	Liquid is water	Tracks standard bowel-preparation instructions
10	At least 16 ounces after first dose	Matches the labeled hydration volume
11	At least 16 ounces after second dose	Matches the second hydration step
12	Each liquid volume consumed within 60 minutes	Narrows the administration timing
13	No clinically significant electrolyte shifts	Adds a functional safety limitation

Claims 4, 9, 10, and 11 have the closest correspondence to the standard 12-tablet SUTAB regimen. Claims 5 through 8 are narrower and may have less relevance to a generic that uses different excipients.

What formulations are protected by US 11,033,498?

The patent protects methods using the specified sodium sulfate, magnesium sulfate, and potassium chloride amounts in an oral dosage form. It also reaches formulations containing sodium caprylate and polyethylene glycol when the claimed ranges are met.

The claims do not require every listed excipient. Claims 5 through 8 are optional dependent claim branches:

• Sodium caprylate alone is covered by claim 5.
• Polyethylene glycol alone is covered by claim 6.
• Both ingredients are covered by claim 7.
• Claim 8 narrows claim 7 to specified quantity ranges.

The patent therefore creates two layers of protection:

1. A broad electrolyte-regimen layer under claim 1.
2. Narrower formulation and excipient layers under claims 5 through 8.

A generic manufacturer could attempt to design around the dependent formulation claims by changing excipients. That strategy would not avoid claim 1 if the generic retains the claimed electrolyte amounts, two-dose regimen, liquid timing, and colon-cleansing function.

How strong is the patent estate for the SUTAB regimen?

The patent has meaningful commercial strength because the independent claim maps onto the principal clinical-use instructions for SUTAB. A generic tablet containing the same salts in the same approximate quantities would face substantial risk if its FDA-approved labeling instructs the same two-dose regimen.

The estate is stronger against products that:

• Use the same three active salts.
• Deliver approximately the claimed quantities per dose.
• Use 12 tablets per dose.
• Require at least 16 ounces of water after each dose.
• Use a split-dose administration schedule.
• Make the same colon-cleansing indication available to patients.

The estate is weaker against products that use:

• A liquid rather than tablet dosage form.
• Different active salts, such as sulfate combinations with materially different composition.
• A single-dose or materially different multi-dose regimen.
• Different electrolyte quantities outside the claim scope.
• A different FDA label that does not instruct the claimed administration sequence.

The use of "about" gives the claims some numerical flexibility. The scope would depend on how a court construes the permitted variation and whether the accused amounts perform substantially the same function in substantially the same way.

When does US Patent 11,033,498 lose exclusivity?

US 11,033,498 issued on June 15, 2021. The patent belongs to a family directed to colon-cleansing compositions and methods of use. Its ordinary 20-year term is calculated from the earliest effective nonprovisional filing date, subject to patent-term adjustment and any applicable terminal disclaimer. The expected unadjusted expiration falls in 2033, but the exact enforceable expiration date should be taken from the USPTO patent record and Orange Book listing rather than inferred solely from the issue date. [1][3]

The patent does not itself establish FDA regulatory exclusivity. Patent exclusivity and FDA exclusivity are separate rights:

• Patent term depends on the patent statute and prosecution history.
• New-drug exclusivity depends on the NDA approval and applicable FDA exclusivity provisions.
• A listed patent can delay FDA approval of an ANDA through the Hatch-Waxman framework if the patent holder brings timely litigation after receiving a Paragraph IV notice.

SUTAB received FDA approval under NDA 213735. Its approval is for adults undergoing colonoscopy and includes the split-dose tablet regimen reflected in the patent claims. [2]

What is the Orange Book status of US 11,033,498?

A patent relevant to SUTAB may be listed in the FDA Orange Book if it claims the drug substance, drug product, or an approved method of use. A method-of-use patent generally requires a corresponding use code identifying the protected indication or administration method.

US 11,033,498 is commercially important as a method patent because its claims are directed to the administration of a colon-cleansing composition. The practical effect of an Orange Book listing depends on:

• Whether the patent is listed against NDA 213735.
• The assigned use code.
• Whether the proposed generic label includes the patented method.
• Whether the ANDA applicant uses a Paragraph IV certification or a section viii carve-out.
• Whether the NDA holder sues within 45 days after receiving a Paragraph IV notice.

The Orange Book is the controlling FDA source for current listing status, use codes, and the FDA-recognized expiration date. [3]

What Paragraph IV challenges and generic entry risks exist?

A generic applicant seeking approval for a SUTAB-equivalent tablet could certify under Paragraph IV that the listed patent is invalid, unenforceable, or not infringed. The likely claim-specific theories would include the following.

Anticipation and obviousness

A challenger could argue that prior bowel-preparation products disclosed:

• Sodium sulfate, magnesium sulfate, and potassium chloride.
• Tablet or oral dosage forms.
• Split dosing.
• Water consumption after each dose.
• Electrolyte monitoring and safety.

The patent holder would respond that the claimed combination of precise electrolyte amounts, tablet administration, hydration timing, colon-cleansing performance, and electrolyte stability was not disclosed in a single prior-art reference and was not obvious as a complete regimen.

Indefiniteness

The terms "about" and "clinically significant electrolyte shifts" create potential Section 112 arguments. The patent holder would rely on the specification, clinical data, and customary pharmaceutical meaning to establish objective boundaries.

Claim 13 presents the greatest indefiniteness exposure because "clinically significant" is a functional and potentially context-dependent phrase. Claims 1 and 13 may also require expert testimony regarding what electrolyte changes are clinically significant in bowel-preparation patients.

Written description and enablement

The broadest claim covers an oral dosage form, while dependent claims specify tablets. A challenger could argue that the disclosure does not support every oral dosage form containing the claimed amounts. That argument is weaker if the specification describes tablets, dosage-unit manufacturing, and clinical administration across the claimed range.

Label-induced infringement

Even if a generic applicant does not manufacture a branded product, an FDA label that instructs patients to use two doses, consume 16 ounces of water after each dose, and administer the same electrolyte amounts could support induced-infringement allegations. A label carve-out may reduce risk only if the patented method can be removed without undermining the approved generic use.

Which competing bowel-preparation products are most relevant?

SUTAB competes with tablet and liquid bowel-preparation products, but the patent does not cover every colon-cleansing product.

Product or category	Principal active ingredients	Dosage form	Relationship to US 11,033,498
SUTAB	Sodium sulfate, magnesium sulfate, potassium chloride	Tablets	Direct commercial target
SUPREP	Sodium sulfate, potassium sulfate, magnesium sulfate	Liquid concentrate	Different composition and dosage form
OsmoPrep	Sodium phosphate salts	Tablets	Different active salts
MoviPrep	Polyethylene glycol with electrolytes	Powder for solution	Different dosage form and composition
GoLYTELY	Polyethylene glycol with electrolytes	Large-volume solution	Different regimen and formulation
Plenvu	Polyethylene glycol and electrolytes	Powder for solution	Different formulation and delivery system

The principal competitive threat is a generic or follow-on sodium sulfate, magnesium sulfate, and potassium chloride tablet. Liquid sulfate products and PEG-based products generally present a different literal infringement profile because they do not reproduce the claimed tablet regimen and composition.

What manufacturing and intellectual-property barriers apply?

A follow-on manufacturer must address more than active-ingredient sourcing. The relevant barriers include:

• Uniform compression of large quantities of inorganic salts into tablets.
• Control of tablet size, friability, dissolution, and swallowability.
• Stability of the electrolyte salts and excipients.
• Reproducible delivery of 12 tablets per dose.
• Clinical or comparative data supporting colon-cleansing efficacy.
• FDA approval of the proposed labeling.
• Orange Book patent certifications.
• Potential litigation over the method claims and related family patents.
• Manufacturing-process patents or know-how not visible from the supplied claims.

The patent does not appear, from the claims provided, to require a particular tablet press, coating system, particle-size distribution, or manufacturing process. A competitor may therefore have more freedom to design its manufacturing process than its clinical label.

Does US 11,033,498 create biosimilar risk?

No. SUTAB is a small-molecule drug product, not a biologic. Biosimilar procedures under the Public Health Service Act do not apply. Competitive entry would proceed through the ANDA pathway for a therapeutically equivalent generic, or potentially through a 505(b)(2) application for a product with material differences in formulation, dosing, or clinical use. [4]

What litigation and settlement issues should investors monitor?

The key litigation triggers are:

1. An ANDA applicant sends a Paragraph IV notice.
2. The NDA holder files suit within the statutory 45-day period.
3. FDA imposes a 30-month stay on final ANDA approval, subject to statutory exceptions.
4. The parties settle through a license, agreed entry date, or other negotiated arrangement.
5. The court rules on claim construction, validity, infringement, or an injunction.

A settlement could permit an authorized generic, a licensed generic launch, or entry before patent expiration under agreed conditions. The commercial value of any settlement would depend on the number of listed patents, the scope of the asserted claims, and whether the generic label preserves the patented split-dose method.

No conclusion about a specific Paragraph IV challenge, litigation docket, or settlement should be drawn solely from US 11,033,498. Those events are separate from the patent's issuance and must be confirmed through FDA Orange Book records, PACER, ANDA litigation filings, and company disclosures.

How does this patent compare with the broader SUTAB patent estate?

US 11,033,498 is best characterized as a regimen patent. Its value is highest when the commercial product and proposed generic label use the complete two-dose administration sequence.

A broader estate may include related patents directed to:

• The electrolyte composition.
• Tablet formulations.
• Excipients such as sodium caprylate and polyethylene glycol.
• Colon-cleansing efficacy.
• Reduced fluid volume.
• Manufacturing methods.
• Other dosing schedules.

The presence of related patents can extend practical market protection beyond the expiration of a single patent. It can also increase Paragraph IV litigation costs because an ANDA applicant may need to defeat or carve out several patents rather than one.

Key Takeaways

• US 11,033,498 is a method patent closely aligned with the SUTAB 12-tablet split-dose regimen.
• Claim 1 requires two doses, specified quantities of sodium sulfate, magnesium sulfate, and potassium chloride, and liquid administration within two hours after each dose.
• Claims 4 and 9 through 12 track the commercial SUTAB instructions most closely.
• Claims 5 through 8 provide narrower protection for sodium caprylate and polyethylene glycol formulations.
• The patent is expected to expire in 2033 under its ordinary term, subject to the official USPTO and Orange Book calculation.
• Generic entry risk is highest for a tablet product with the same electrolyte quantities, 12-tablet dosing, 16-ounce water instructions, and split-dose label.
• The patent does not create biosimilar risk because SUTAB is a small-molecule drug.
• The Orange Book listing, use code, Paragraph IV activity, and related patent-family claims determine the practical scope of market protection.
• A full freedom-to-operate analysis must evaluate the entire SUTAB patent family, not US 11,033,498 alone.

FAQs

What is the active ingredient in SUTAB?

SUTAB contains sodium sulfate, magnesium sulfate, and potassium chloride. Each 12-tablet dose delivers approximately 17.75 grams, 2.7 grams, and 2.25 grams, respectively.

Is US 11,033,498 a composition patent or a method patent?

It is principally a method-of-use patent. The claims require administering the composition in a specified two-dose colon-cleansing regimen.

Can a liquid bowel preparation infringe US 11,033,498?

A liquid product could avoid the tablet-specific claims, but it could face claim 1 if it meets the broader oral-dosage-form, electrolyte, two-dose, liquid-timing, and colon-cleansing limitations.

Can a generic omit the patented SUTAB dosing instructions?

A generic applicant may seek a section viii labeling carve-out where legally available. The carve-out must remove the patented method without eliminating the approved generic use or creating a label that still instructs the claimed regimen.

What is the likely commercial entry date for a SUTAB generic?

The entry date depends on the earliest enforceable expiration of all relevant Orange Book-listed patents, the outcome of Paragraph IV litigation, any regulatory exclusivity, and the terms of any settlement or license.

References

1. United States Patent and Trademark Office. (2021). U.S. Patent No. 11,033,498: Colon cleansing compositions and methods of use.
2. U.S. Food and Drug Administration. (2020). SUTAB prescribing information, NDA 213735. Sebela Pharmaceuticals Inc.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. Food and Drug Administration. (2024). Abbreviated new drug application and 505(b)(2) application pathways.

Drugs Protected by US Patent 11,033,498

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020	AB	RX	Yes	Yes						GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY