Details for Patent: 10,792,306

Which drugs does patent 10,792,306 protect, and when does it expire?

Patent 10,792,306 protects PLENVU and is included in one NDA.

This patent has seventy-one patent family members in thirty-four countries.

Summary for Patent: 10,792,306

Title:	Colonoscopy—preparation
Abstract:	The invention provides a colon cleansing solution comprising: a) 300 to 2000 mmol per litre ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof; and b) 10 to 200 g per litre polyethylene glycol. The invention also provides methods and kits associated with, or making use of the solutions. The invention also provides a method of cleansing the colon of a subject comprising: —administering to the subject an effect amount of a first cleansing solution; and then after a time interval—administering to the subject an effective amount of a second cleansing solution, wherein the two cleansing solutions are as described in the specification.
Inventor(s):	Marc Halphen, Hans-Jurgen Gruss, Ian Cox, Alasdair Cockett, Peter Stein, Alex Ungar
Assignee:	Norgine BV
Application Number:	US16/788,527
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,792,306
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Device;

United States Patent 10,792,306: Claim Scope, Exclusivity, and Patent Landscape for Low-Volume Colon-Cleansing Kits

US Patent 10,792,306 protects a two-part, low-volume colon-cleansing regimen combining polyethylene glycol 3350-class material, sodium sulfate, electrolytes, and an ascorbate system made from sodium ascorbate and ascorbic acid. The broadest claims cover both dry-powder kits and preconstituted solutions, while separate claims cover administration of the two solutions in a split-dose regimen. The commercial formulation most closely associated with the claims is PLENVU, marketed in the United States by Salix Pharmaceuticals, a division of Bausch Health, and developed by Norgine.

The patent’s practical risk is highest for a product using:

• A first 400 to 600 mL dose containing approximately 100 g PEG, 9 g sodium sulfate, and specified electrolytes;
• A second 400 to 600 mL dose containing approximately 40 g PEG and an ascorbate system;
• Sodium ascorbate and ascorbic acid in a weight ratio between 1:10 and 10:1;
• The specified sucralose or aspartame taste systems; and
• An evening-to-morning split-dose schedule.

What does US Patent 10,792,306 protect?

The patent protects a low-volume, two-component bowel-preparation system rather than PEG as a general laxative.

Its claim architecture has four principal categories:

Claim group	Protected subject matter	Key limitation
Claims 1-11	Two dry components to be mixed with water	First component contains PEG and sodium sulfate; second contains PEG and ascorbate
Claims 12-19	Two prepared colon-cleansing solutions	Concentrations are expressed per liter
Claims 20-21	Method of cleansing the colon	Administration of both solutions, optionally from evening to following morning
Claims 22-30	More narrowly closed kit formulations	“Consisting of” language limits additional ingredients

The patent is therefore relevant to both finished products and certain manufacturing or commercialization formats. A manufacturer could face infringement exposure even if it sells a kit rather than a ready-to-drink solution, because claims 1 and 26 expressly cover compositions intended for admixture with 400 to 600 mL of water.

What are the broadest independent claims?

Claim 1: broad dry-component kit

Claim 1 requires a kit with two components:

1. A first component for preparation of a first cleansing solution; and
2. A second component for preparation of a second cleansing solution.

The first component must contain:

• 90 to 112.5 g polyethylene glycol;
• PEG with an average molecular weight of 2,500 to 4,500 Da; and
• 3.75 to 11.25 g sodium sulfate.

The second component must contain:

• 50 to 60 g ascorbate anion;
• Ascorbate supplied by both sodium ascorbate and ascorbic acid;
• A sodium ascorbate-to-ascorbic acid weight ratio of 1:10 to 10:1; and
• 15 to 45 g PEG with an average molecular weight of 2,500 to 4,500 Da.

Because claim 1 uses “comprising,” additional ingredients generally do not avoid the claim if every required element remains present.

The 400 to 600 mL water limitation applies to the intended preparation of each component. A product label specifying 500 mL dilution falls directly within the claimed range.

Claim 12: preconstituted solution kit

Claim 12 shifts from powder amounts to solution concentrations. It requires:

• A first solution containing 100 to 200 g/L PEG and 8.0 to 20 g/L sodium sulfate; and
• A second solution containing 100 to 120 g/L ascorbate anion and 30 to 90 g/L PEG.

The solutions must be prepared in 400 to 600 mL of water. Claims 13 to 19 add narrower concentration, electrolyte, sweetener, and volume limitations.

Claim 12 creates a separate infringement route. A product might avoid the dry-powder amounts in claim 1 but still fall within the concentration ranges of claim 12 after reconstitution.

Claim 20: method-of-treatment claim

Claim 20 covers administering an effective amount of each solution defined in claim 12. Claim 21 adds a split-dose interval extending from the evening to the following morning.

This method claim creates potential exposure for use instructions, labeling, promotional materials, and physician-directed administration. Method infringement analysis would depend on who performs the claimed acts and whether the relevant administration is induced or directly performed.

How do the dependent claims narrow the formulation?

Claims 2 through 11 and claims 13 through 19 add commercially important formulation limitations.

First solution limitations

The first component or first solution can include:

• PEG at 100 g or 100 to 200 g/L;
• Sodium sulfate at 9 g or 8.0 to 20 g/L;
• Sodium chloride;
• Potassium chloride;
• Sucralose;
• Flavoring agents; and
• A 500 mL final volume.

These limitations correspond closely to the first PLENVU dose. The first solution is also required by claim 11 to be substantially free from ascorbic acid and its salts. That separation is technically significant because the patent allocates the ascorbate load to the second dose.

Second solution limitations

The second component or second solution can include:

• 40 g PEG;
• 30 to 90 g/L PEG;
• 80 g/L PEG;
• 1.5 to 3.5 g sodium chloride;
• 1 to 2.5 g potassium chloride;
• Aspartame;
• Flavoring agents; and
• A 500 mL final volume.

The use of both sodium ascorbate and ascorbic acid is mandatory in the independent claims. A second solution containing only ascorbic acid, only sodium ascorbate, or a different ascorbate source presents a potential noninfringement position, subject to equivalents and claim construction.

What is the commercial formulation most closely aligned with the patent?

The claimed architecture corresponds closely to the two-dose PLENVU formulation. FDA labeling identifies PLENVU as a low-volume bowel-cleansing product supplied as Dose 1 and Dose 2 sachets. The label requires each dose to be dissolved in water and supplemented with additional clear liquid intake. [2]

Product element	Claimed architecture	PLENVU alignment
First dose	PEG plus sodium sulfate	Yes
First dose volume	400-600 mL, commonly 500 mL	Yes
Second dose	PEG plus sodium ascorbate and ascorbic acid	Yes
Second dose volume	400-600 mL, commonly 500 mL	Yes
First-dose sweetener	Sucralose option	Yes
Second-dose sweetener	Aspartame option	Yes
Split-dose administration	Evening and following morning option	Yes

The product label alone does not establish infringement. The relevant analysis must compare the approved formulation, manufacturing specifications, and instructions for use with each claim limitation.

What formulation patents are most relevant to the competitive landscape?

The main competitive products divide into low-volume sulfate preparations, high-volume PEG-electrolyte solutions, tablet-based preparations, and PEG-ascorbate solutions.

Product	Active cleansing platform	Approximate administration burden	Primary patent risk relative to US 10,792,306
PLENVU	PEG, sodium sulfate, sodium ascorbate, ascorbic acid, electrolytes	Low-volume doses plus additional fluids	Highest overlap
MOVIPREP	PEG-electrolyte and ascorbate-based solution	Low-volume product plus additional fluids	Potentially relevant prior-art and formulation comparison
SUPREP	Sodium sulfate, potassium sulfate, magnesium sulfate	Low-volume dose plus additional fluids	Low direct overlap because it lacks the claimed PEG-ascorbate structure
SUTAB	Sulfate-based tablets	Multiple tablets plus substantial water	Low direct overlap with the claimed liquid formulation
GoLYTELY and generics	High-volume PEG-electrolyte solution	Approximately 4 L	Low direct overlap with low-volume two-component claims
MiraLAX-based regimens	PEG 3350 without the claimed sodium sulfate/ascorbate kit structure	Variable	Low direct overlap

The most relevant patent landscape is not all bowel-preparation patents. It is the narrower group covering low-volume PEG-ascorbate systems, two-stage dosing, electrolyte balancing, taste masking, and methods of administering the doses over separate time periods.

How strong is the patent estate for this formulation?

Technical strengths

The claims have several elements that make exact-copy risk comparatively high:

1. They require a specific two-component architecture.
2. They define both ingredient quantities and PEG molecular-weight ranges.
3. They require ascorbate from both sodium ascorbate and ascorbic acid.
4. They specify a ratio range broad enough to capture many practical salt/acid combinations.
5. They cover both dry compositions and reconstituted solutions.
6. They include formulation-dependent claims for electrolytes and sweeteners.
7. They include a method claim directed to administration.

The combination of these limitations creates layered protection. A competitor that changes the dosage form from powder to liquid may still face claim 12. A competitor that changes the final formulation may still face claim 1 if the dry-component quantities remain within range.

Potential claim vulnerabilities

The principal design-around and validity issues are:

• Whether “50 to 60 g ascorbate anion” refers to the mass of ascorbate anion or the mass of the supplied ascorbate salts;
• Whether the claimed ranges are supported across their full breadth;
• Whether prior art disclosed a two-dose PEG-ascorbate system with the claimed ratio and electrolyte profile;
• Whether the PEG molecular-weight limitation materially distinguishes the prior art;
• Whether “substantially free from ascorbic acid and salts thereof” has a sufficiently definite boundary;
• Whether the “consisting of” language in claims 22 and 26 creates prosecution-history or consistency issues; and
• Whether claim 20 is enabled across all effective doses and administration schedules.

The patent’s strongest enforcement position is likely against a product that copies the commercially optimized formulation. Its weakest position is likely against substantially different sulfate, tablet, or high-volume PEG products.

What is the legal significance of “comprising” versus “consisting of”?

Claims 1 and 12 use “comprising.” These claims generally permit additional ingredients. A formulation containing the claimed ingredients plus additional buffers, flavorants, preservatives, or excipients may still infringe.

Claims 22 and 26 use “consisting of.” These claims are narrower. The listed components may be treated as exhaustive, subject to established claim-construction rules and any transitional-language interpretation supported by the specification and prosecution history.

This distinction creates a practical hierarchy:

• Claims 1 and 12 are broader and more useful against modified commercial formulations.
• Claims 22 and 26 are narrower but may map more precisely onto the marketed product.
• Dependent claims 27 through 30 provide additional protection for sweeteners, 500 mL preparation, and component presentation.

The supplied text contains a drafting inconsistency: claim 26 refers to the second component with a period after “polyethylene glycol,” followed by additional limitations. The effect of that punctuation would be assessed from the issued patent, prosecution history, and claim-construction principles rather than the text alone.

When does US Patent 10,792,306 lose exclusivity?

The patent issued on November 3, 2020. Its effective expiration cannot be fixed from the claim text alone because the controlling date depends on the patent’s effective US filing date, patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

The patent should be analyzed separately from FDA regulatory exclusivity:

Exclusivity right	Relevance
Patent term	Protects claimed kits, solutions, and methods until expiration, subject to validity and enforceability
FDA new-drug exclusivity	Depends on the NDA’s regulatory classification and approval history
Orange Book listing	Determines whether an ANDA applicant must address the patent through certification
Pediatric exclusivity	Adds six months only if granted for the relevant product and conditions
Patent-term extension	May extend an eligible product patent for qualifying regulatory delay

PLENVU received FDA approval under NDA 209381 in 2018. The product’s approval date does not by itself determine the expiration of US Patent 10,792,306. [2] Patent and regulatory exclusivity must be checked independently in the USPTO patent record, FDA Orange Book, and NDA history. [1, 3]

What is the Orange Book status of US Patent 10,792,306?

The claim text does not establish Orange Book listing status. Orange Book listing depends on the NDA holder’s submission and FDA’s accepted listing for a drug substance, drug product, or method-of-use patent.

If listed against PLENVU, the patent could require an ANDA applicant to submit one of the following certifications:

• Paragraph I: no relevant patent information has been submitted;
• Paragraph II: the patent has expired;
• Paragraph III: the applicant will wait for expiration;
• Paragraph IV: the patent is invalid, unenforceable, or will not be infringed; or
• A section viii statement for a method-of-use patent where the applicant omits the patented use.

Because this patent contains formulation and method claims, a product-specific Orange Book analysis must distinguish the listed claims. A formulation patent may block an ANDA even where the applicant omits a patented method of use. Conversely, a section viii strategy may be relevant only if the ANDA product can avoid the listed method claims and the formulation claims do not independently cover the product.

Which companies are most likely to challenge the patent?

The most likely challengers are manufacturers developing an ANDA for a PEG-ascorbate low-volume bowel preparation or a therapeutically substitutable product that seeks PLENVU-like labeling.

Potential challenger categories include:

• Generic manufacturers of PEG-electrolyte bowel preparations;
• Companies with existing MOVIPREP or PEG-ascorbate manufacturing capability;
• Contract manufacturers developing private-label bowel-cleansing products; and
• Branded competitors seeking a lower-volume formulation.

A company selling SUPREP, SUTAB, or a conventional 4 L PEG product would have less direct incentive to challenge this patent because those products do not require the claimed PEG-plus-ascorbate architecture.

No conclusion about a specific Paragraph IV notice, district-court complaint, settlement, or inter partes review follows from the claim text supplied. Those events are separate public-record questions and do not alter the technical scope of the issued claims.

What generic launch scenarios exist?

Scenario 1: exact or near-exact PLENVU generic

A generic using the same two-dose powder architecture would face the highest risk. The applicant would likely need to address:

• Claims 1 and 26 for the dry kit;
• Claims 12 and 22 for reconstituted solutions;
• Claims 5 through 8 and 14 through 17 for electrolyte and sweetener selections; and
• Claims 20 and 21 for the labeled dosing method.

A Paragraph IV certification would be the most likely pathway if the patent were listed and still enforceable.

Scenario 2: altered ascorbate system

A product using only ascorbic acid, only sodium ascorbate, calcium ascorbate, or another vitamin C salt could target the requirement that the ascorbate anion be provided by both sodium ascorbate and ascorbic acid. The risk would turn on the final composition, equivalence, and whether other patent families cover the alternative.

Scenario 3: altered PEG or sulfate levels

Moving outside the claimed PEG, sodium sulfate, or concentration ranges could avoid literal infringement. Range changes must be commercially meaningful and must account for possible infringement under the doctrine of equivalents.

Scenario 4: non-PEG sulfate product

Sulfate-only liquids or tablets have a stronger structural design-around position because the patent requires PEG in both the first and second components.

What manufacturing and geographic barriers matter?

The patent claims are product and method claims. They do not, based on the supplied text, expressly claim a particular manufacturing process, granulation method, packaging configuration, or facility.

Manufacturing risks remain relevant because:

• The two components must maintain chemical and physical stability;
• Sodium ascorbate and ascorbic acid ratios must remain within the claim range;
• PEG molecular weight must be controlled;
• Sachet fill weights must meet the claimed mass ranges;
• Taste systems may be tied to narrower dependent claims; and
• Reconstitution volume can determine whether the product falls within the 400 to 600 mL limitation.

US patent rights generally govern manufacture, sale, offers for sale, importation, and use in the United States. Foreign equivalents must be assessed separately. A US patent does not itself create patent rights in Europe, Canada, Australia, or other markets. The relevant international family members, prosecution outcomes, and national expiration dates must be reviewed jurisdiction by jurisdiction.

What patent litigation affects this product?

The supplied materials identify no litigation caption, court, docket, settlement, or Paragraph IV notice. The issued claims alone therefore support a technical infringement analysis, not a litigation-status finding.

For commercial diligence, the material litigation questions are:

• Whether the NDA holder listed the patent in the Orange Book;
• Whether an ANDA applicant filed a Paragraph IV certification;
• Whether a 30-month stay was triggered;
• Whether the patent was challenged in district court or at the Patent Trial and Appeal Board;
• Whether any settlement permits an authorized generic or delayed launch; and
• Whether later continuation patents protect additional formulations or uses.

Key Takeaways

• US Patent 10,792,306 covers a two-component, low-volume colon-cleansing kit and corresponding prepared solutions.
• The core combination is PEG plus sodium sulfate in the first dose and PEG plus sodium ascorbate/ascorbic acid in the second dose.
• Claims 1, 12, 22, and 26 are the main infringement targets.
• Claims 20 and 21 extend protection to administering the claimed solutions, including an evening-to-morning split-dose regimen.
• The claimed architecture closely tracks PLENVU’s commercial presentation.
• A generic copying the PLENVU formulation faces materially higher risk than a sulfate-only tablet or non-PEG liquid.
• The ascorbate source, PEG molecular weight, dose volumes, sodium sulfate amount, and closed-formulation language are the principal design-around variables.
• Patent expiration, Orange Book listing, Paragraph IV activity, litigation, and settlement status are separate from the technical claim scope and must be confirmed in the relevant public records.

FAQs

Does a product need to contain exactly 500 mL to infringe?

No. The independent claims cover preparation in 400 to 600 mL of water. A 500 mL presentation is a narrower claimed embodiment, not the exclusive volume.

Can a competitor avoid the patent by using PEG 3350 instead of generic PEG?

Not necessarily. PEG 3350 is within the claimed average molecular-weight range if the product’s PEG material has an average molecular weight between 2,500 and 4,500 Da.

Does the patent cover a single-bottle bowel preparation?

The independent claims require first and second components or first and second solutions. A single formulation that does not preserve that two-part structure has a stronger noninfringement position, although other patent claims may apply.

Is ascorbic acid alone within the claims?

The independent claims require the ascorbate anion to be provided by both sodium ascorbate and ascorbic acid. A formulation using ascorbic acid alone does not literally satisfy that limitation.

Does a different sweetener avoid the patent?

Changing sucralose or aspartame may avoid specific dependent claims, but it does not necessarily avoid claims 1 or 12, which do not require a particular sweetener.

References

1. United States Patent and Trademark Office. (2020). United States Patent No. 10,792,306, Bowel cleansing compositions.
2. U.S. Food and Drug Administration. (2018). PLENVU prescribing information, NDA 209381.
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). Drugs@FDA: FDA-approved drugs database, PLENVU.

Drugs Protected by US Patent 10,792,306

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Salix	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		RX	Yes	Yes	10,792,306		Y			FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Foreign Priority and PCT Information for Patent: 10,792,306

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1104200.9	Mar 11, 2011
United Kingdom	1104202.5	Mar 11, 2011
United Kingdom	1114629.7	Aug 23, 2011

International Family Members for US Patent 10,792,306

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3141251		122021000018	Germany
European Patent Office	3141251		132021000000044	Italy
European Patent Office	3141251		301099	Netherlands