When will the PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL patents expire, and when will generic PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novel Labs Inc	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL	202217-001	Aug 20, 2014		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: September 26, 2026

The combination of polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl is the bowel-preparation product historically marketed in the United States as HalfLytely and Bisacodyl Tablets Bowel Prep Kit. Its commercial trajectory has been shaped by generic substitution, competition from lower-volume preparations, declining differentiation of the formulation, and limited disclosure of product-level revenue. The product has no biosimilar pathway and faces primarily generic and therapeutic-substitution risk.

What drug contains PEG-3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl?

The formulation is associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kit, an oral solution and tablet combination used for cleansing the colon before colonoscopy or other diagnostic procedures.

Product composition and use

The powder component contains:

Component	Function
Polyethylene glycol 3350	Osmotic lavage agent
Sodium chloride	Electrolyte replacement
Sodium bicarbonate	Buffer and electrolyte
Potassium chloride	Electrolyte replacement
Bisacodyl	Stimulant laxative

The PEG-electrolyte solution is designed to produce substantial stool water retention while limiting net electrolyte shifts. Bisacodyl adds stimulant activity and permits a lower total lavage volume than some conventional four-liter PEG regimens.

The product is a prescription bowel-preparation kit rather than a chronic-use pharmaceutical. Revenue depends on colonoscopy volumes, gastroenterology prescribing habits, payer coverage, pharmacy substitution and the availability of competing preparations.

What is the FDA regulatory status of HalfLytely and Bisacodyl?

The product was approved through FDA New Drug Application No. 021881. The FDA labeling identifies the product as a prescription bowel-cleansing preparation containing PEG-3350 and electrolytes with bisacodyl tablets.[1]

Regulatory item	Status
Product	HalfLytely and Bisacodyl Tablets Bowel Prep Kit
Dosage form	Oral solution powder plus delayed-release bisacodyl tablets
FDA pathway	New Drug Application
NDA	021881
Therapeutic category	Gastrointestinal bowel cleansing
Primary use	Preparation for colonoscopy and diagnostic procedures
Biologic status	Not a biologic
Biosimilar exposure	None
Generic exposure	High

The product’s clinical value is procedural rather than disease-modifying. It does not receive the type of recurring prescription demand associated with chronic cardiovascular, metabolic or immunology therapies.

How does the FDA regulate this product category?

FDA regulation focuses on dose instructions, electrolyte balance, contraindications, renal and cardiac risks, aspiration risk and safe administration. Bowel-preparation products are also affected by labeling changes involving dehydration, fluid shifts and electrolyte abnormalities.[1]

The product category includes prescription and over-the-counter preparations. Prescription products compete on volume, tolerability, dosing schedule, flavor, split-dose convenience and perceived cleansing quality.

When does PEG-3350 and bisacodyl lose market exclusivity?

Market exclusivity has effectively been lost through the availability of generic PEG-electrolyte bowel preparations and competing branded products. The commercial issue is no longer the expiration of a single core patent. It is the erosion of branded differentiation across a product class built largely from established ingredients.

Exclusivity timeline

Period	Market event
Early 2000s	PEG-electrolyte lavage products were established in colonoscopy preparation
Mid-2000s	HalfLytely and bisacodyl combination commercialized as a lower-volume alternative to traditional PEG regimens
Late 2000s to early 2010s	Generic PEG-electrolyte solutions and alternative bowel preparations expanded
2010 onward	Suprep, MoviPrep, MiraLAX-based regimens and other lower-volume approaches increased competitive pressure
2015 onward	Prescription bowel-preparation competition became increasingly dependent on payer access and procedure-center protocols
Current market	The combination has little practical exclusivity and faces generic substitution and therapeutic substitution

The relevant commercial protection was historically tied to formulation, dosage regimen, branding and regulatory approval. Those protections do not create a durable barrier once generic PEG-electrolyte alternatives become available.

What patents protect the PEG-3350 and bisacodyl bowel-prep combination?

The patent estate is commercially weak relative to newer branded products because the active ingredients are old, widely used and chemically straightforward. Any historic patents would have focused on formulation, preparation volume, administration sequence, kit design or the combination of PEG-electrolyte solution with bisacodyl.

Formulation patent exposure

The principal technical features that could support patent protection include:

A defined PEG-electrolyte composition
The concentration and ratio of sodium and potassium salts
Reconstitution in a specified volume
Combination packaging with bisacodyl tablets
A dosing sequence using bisacodyl before PEG-electrolyte solution
Flavoring, buffering or stability characteristics
A reduced-volume administration regimen

Those features are vulnerable to design-around strategies. A generic manufacturer can use a different electrolyte concentration, different tablet strength, different packaging or a separate administration protocol while preserving the same clinical purpose.

The FDA Orange Book is the relevant source for patents listed against an approved small-molecule drug application.[2] For this product class, patent risk must be assessed against the specific NDA and the current Orange Book entry rather than against the ingredients generally. The ingredients themselves do not provide meaningful patent exclusivity.

Is there a method-of-use patent barrier?

Method-of-use protection is limited. Colon cleansing before colonoscopy is a well-established indication, and broad claims directed to that use would face substantial validity and obviousness risk. More defensible claims would require a specific dosing schedule, patient population, safety limitation or clinical result.

A method-of-use patent would also be difficult to enforce commercially because bowel-preparation instructions are often implemented through physician protocols, pharmacy substitution and procedure-center order sets rather than through a single branded prescription.

How many patents cover this drug?

The commercial product should be treated as having a limited and largely historical patent estate. The active ingredients are not new chemical entities, and the combination does not have the patent density associated with biologics, long-acting injectables or complex drug-delivery systems.

A current freedom-to-operate analysis would need to distinguish:

Patents listed in the Orange Book against NDA 021881.
Expired patents that no longer constrain launch.
Unlisted formulation or packaging patents.
Third-party patents covering manufacturing or alternative bowel-preparation regimens.
Patent claims that remain enforceable in jurisdictions outside the United States.

The practical conclusion is that patent expiry is not the main barrier to competition. Manufacturing scale, FDA approval, retailer access, payer positioning and physician adoption are more relevant.

Which companies challenge the product commercially?

The product competes with both direct generic equivalents and alternative bowel-preparation regimens.

Competitor	Main commercial advantage
Generic PEG-electrolyte solutions	Low price and broad substitution
GoLYTELY and generic equivalents	Established four-liter PEG platform
MiraLAX-based regimens	Flexible use and broad consumer familiarity
MoviPrep	Lower-volume PEG-based preparation
Suprep	Low-volume sulfate-based regimen
Sutab	Tablet-based administration
Plenvu	Lower-volume PEG-based preparation
Clenpiq	Ready-to-drink lower-volume format

The closest direct substitutes are generic PEG-electrolyte preparations. Suprep, Sutab, Plenvu and Clenpiq create therapeutic substitution pressure by offering different administration formats or lower-volume protocols.

What is the Orange Book status of HalfLytely?

The product is associated with NDA 021881 in FDA product databases. Orange Book analysis should focus on whether the NDA has active patent listings, whether those listings have expired and whether any generic abbreviated new drug applications have been approved or remain commercially active.[2,3]

The commercial status of an NDA and the availability of a branded product are separate issues. A product can retain an approved NDA while experiencing declining distribution, discontinuation of a particular package configuration or substitution by generic products.

The combination should not be analyzed as a biosimilar product. Biosimilar concepts apply to biological products, while this product is a conventional small-molecule and polymer-based oral drug product.

What generic entry risks exist?

Generic entry risk is high and persistent. The main risk categories are:

Direct generic substitution

A generic PEG-3350 and electrolyte solution can compete directly on prescription price and pharmacy substitution. Bisacodyl may be supplied as part of a kit or obtained separately, reducing the need for a branded combination package.

Therapeutic substitution

Even if a direct equivalent is unavailable, physicians can prescribe another bowel-preparation product. Procedure centers frequently standardize on a limited number of regimens based on cost, volume, patient tolerance and payer coverage.

Private-label and wholesale competition

Bowel-preparation products are suitable for private-label distribution because the active ingredients are mature and the clinical use is standardized. Wholesalers and pharmacy chains can negotiate on price and stock competing products interchangeably.

Protocol substitution

Hospitals and endoscopy centers can change bowel-preparation protocols without changing the underlying clinical objective. This reduces brand loyalty and limits the value of historical formulation patents.

How strong is the patent estate for this product?

The patent estate is weak to moderate from a historical perspective and weak from a current commercial perspective.

Patent-strength factor	Assessment
New chemical entity protection	None
Biologic exclusivity	None
Ingredient novelty	Low
Formulation differentiation	Limited
Method-of-use protection	Narrow
Generic design-around risk	High
Manufacturing complexity	Low to moderate
Regulatory switching cost	Low
Commercial durability	Low

Manufacturing requires appropriate blending, packaging, quality control and stability testing, but it does not present the high technical barriers associated with sterile injectables, inhaled suspensions or complex biologic products.

What manufacturing and intellectual-property barriers remain?

The key manufacturing requirements are control of powder uniformity, moisture protection, dissolution performance, electrolyte concentration, tablet stability and package integrity. The combination must be manufactured under current good manufacturing practice and supported by appropriate quality documentation.

These requirements create execution risk but not a strong exclusionary barrier. A qualified generic manufacturer can reproduce the product category using established pharmaceutical processes.

The most defensible technical barriers would involve:

A proprietary low-volume composition with demonstrated clinical advantages
Improved palatability or reduced nausea
Stable combination packaging
A differentiated ready-to-drink format
A clinically validated dosing sequence
Strong product-specific safety data

The historical PEG-3350 and bisacodyl combination does not appear to possess the level of technical differentiation now associated with tablet-based or ready-to-drink bowel-preparation products.

What is the financial trajectory of the product?

Standalone revenue for HalfLytely is not separately reported in the public filings of the companies that have marketed or distributed related gastrointestinal products. Public company disclosures generally combine products into broader gastrointestinal or prescription-product revenue categories.[4,5]

The financial trajectory is therefore best described by market structure:

Financial phase	Revenue profile
Launch and adoption	Growth from demand for a lower-volume alternative to four-liter PEG products
Competitive expansion	Slowing growth as generic PEG solutions and branded alternatives entered
Mature branded period	Price and volume pressure from substitution
Generic erosion	Declining branded revenue and reduced gross-margin potential
Late commercial period	Limited product-level visibility and dependence on residual prescriptions or distribution rights

Revenue drivers

Revenue has been linked to:

Colonoscopy procedure volumes
Screening recommendations and compliance
Endoscopy-center purchasing
Prescription coverage
Copay levels
Generic substitution
Product availability
Patient preference for lower-volume or tablet-based regimens

Revenue constraints

The principal constraints are:

Low treatment frequency
Mature ingredients
Limited switching costs
Numerous alternatives
Payer pressure
Procedure-center formularies
Lack of long-term patient retention
Difficulty sustaining premium pricing

The product cannot be valued like a chronic-care franchise. Its economic value is closer to a mature procedural-support product, with revenue tied to procedure counts and distribution access.

How does PEG-3350 and bisacodyl compare with Sutab, Suprep and Plenvu?

Attribute	PEG-3350 plus bisacodyl	Suprep	Sutab	Plenvu
Main format	PEG solution plus bisacodyl tablets	Oral sulfate solution	Tablets	PEG-based low-volume solution
Volume positioning	Lower than traditional four-liter PEG, depending on regimen	Low volume with additional clear liquids	Tablet-based, high pill burden	Low-volume PEG regimen
Generic pressure	High	Moderate to high	Lower while branded	Moderate
Differentiation	Combination and dosing sequence	Sulfate formulation and low volume	Tablet format	Low-volume PEG formulation
Manufacturing complexity	Low to moderate	Moderate	Higher tablet burden	Moderate
Prescriber sensitivity	Cost and familiarity	Tolerability and coverage	Patient preference and pill burden	Volume and cleansing performance
Long-term commercial outlook	Mature or declining	Competitive branded segment	Potentially stronger differentiation	Competitive branded segment

Sutab has a different administration experience and may command stronger brand positioning because patients avoid drinking a large volume of lavage solution. Suprep competes through low volume and established physician familiarity. Plenvu competes through reduced volume within the PEG class.

What litigation or settlement agreements affect the product?

The product’s principal legal risk is generic competition rather than active patent litigation. No major continuing patent-litigation narrative is central to the current commercial profile of this combination based on the public regulatory and company-disclosure record reviewed for this analysis.

For any ANDA challenge, the relevant questions would be:

Whether a generic applicant submitted a Paragraph IV certification.
Whether the NDA holder filed suit within 45 days.
Whether a 30-month stay applied.
Whether the disputed patent was listed and enforceable.
Whether a settlement created a licensed entry date.
Whether the challenged patent has since expired.

Paragraph IV litigation is more commercially consequential when a product has a meaningful branded market and active listed patents. The economic value of such litigation is lower for a mature bowel-preparation product with extensive therapeutic substitution.

What is the outlook for generic launch and commercial investment?

The likely launch environment is favorable for generic manufacturers but unattractive for high-risk branded investment.

Generic launch scenario

A generic entrant would benefit from:

Mature active ingredients
Familiar dosage technology
Established clinical use
Low expected physician education costs
Potential pharmacy substitution
Ability to compete through price

The entrant would face:

Limited market size
Multiple competing preparations
Pricing pressure
Inventory and distribution requirements
Possible differences in kit configuration
Need to demonstrate pharmaceutical equivalence and adequate labeling

Investment outlook

A new branded investment would require a clear commercial advantage, such as:

Meaningfully lower administered volume
Improved taste
Better tolerability
Lower renal or electrolyte risk
Convenient tablet or ready-to-drink format
Favorable payer contracting
Procedure-center adoption

A reformulation without a measurable patient or provider benefit would have limited pricing power.

Key Takeaways

The formulation is historically associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kit, NDA 021881.
It is a conventional oral bowel-preparation product, not a biologic and not subject to biosimilar competition.
Core ingredient protection is absent because PEG-3350, electrolytes and bisacodyl are established substances.
Formulation and method-of-use patents offer limited current commercial protection.
Generic PEG-electrolyte solutions create high direct substitution risk.
Suprep, Sutab, Plenvu, MoviPrep and Clenpiq create substantial therapeutic-substitution pressure.
Product-level revenue has not been separately disclosed in public filings.
The financial trajectory is consistent with a mature, low-frequency prescription product facing price erosion and declining branded differentiation.
Manufacturing barriers are manageable and do not create a strong exclusionary moat.
Future value depends on low-volume delivery, tolerability, patient convenience, payer access and endoscopy-center protocol adoption.

FAQs

Is PEG-3350 with electrolytes the same as MiraLAX?

No. MiraLAX contains PEG-3350 without the same electrolyte composition. MiraLAX-based bowel-preparation regimens may be used under physician-directed protocols but are not identical to a prescription PEG-electrolyte kit.

Is HalfLytely still commercially available?

Commercial availability can vary by package, manufacturer and distributor. The historical brand has faced substantial generic and therapeutic substitution, and product listing in FDA databases does not guarantee broad retail availability.

Does bisacodyl create a separate patent barrier?

No meaningful current barrier is created by bisacodyl itself. Bisacodyl is an established stimulant laxative. Any relevant protection would have to arise from the specific formulation, kit, dosing sequence or method of use.

Can a generic manufacturer sell PEG-3350 and bisacodyl as separate products?

A manufacturer may pursue separate approved products or a combination kit, depending on the applicable FDA pathway and labeling requirements. Separate products can still compete with a branded combination through physician-directed use and pharmacy dispensing.

What is the strongest commercial differentiator in the bowel-preparation market?

Lower administered volume, better tolerability and convenient administration are the strongest differentiators. Price and payer coverage remain decisive because bowel preparation is a short-duration, highly substitutable therapy.

References

U.S. Food and Drug Administration. (n.d.). HalfLytely and bisacodyl tablets bowel prep kit prescribing information. DailyMed.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. FDA.
Salix Pharmaceuticals, Ltd. (2014). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.
Bausch Health Companies Inc. (2023). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.
American College of Gastroenterology. (2021). Optimizing bowel preparation quality for colonoscopy: Recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer. The American Journal of Gastroenterology, 116(11), 2095-2114.

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL at DailyMed

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