PEDIAPRED Drug Patent Profile

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Which patents cover Pediapred, and when can generic versions of Pediapred launch?

Pediapred is a drug marketed by Pai Holdings and is included in one NDA.

The generic ingredient in PEDIAPRED is prednisolone sodium phosphate. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pediapred

A generic version of PEDIAPRED was approved as prednisolone sodium phosphate by BAUSCH AND LOMB INC on July 29^th, 1994.

Summary for PEDIAPRED

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	6
Patent Applications:	7,408
What excipients (inactive ingredients) are in PEDIAPRED?	PEDIAPRED excipients list
DailyMed Link:	PEDIAPRED at DailyMed

Recent Clinical Trials for PEDIAPRED

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Myrtelle Inc.	Phase 1/Phase 2
CureRareDisease LLC	Phase 1/Phase 2
Nancy Bauman	Phase 2

See all PEDIAPRED clinical trials

Pharmacology for PEDIAPRED

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for PEDIAPRED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pai Holdings	PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157-001	May 28, 1986	AA	RX	Yes	Yes

Expired US Patents for PEDIAPRED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pai Holdings	PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157-001	May 28, 1986	4,448,774

Pediapred Market Dynamics, Patent Status, Generic Competition, and Financial Trajectory

Last updated: November 5, 2026

Pediapred is a legacy oral corticosteroid brand containing prednisolone sodium phosphate. Its commercial position has deteriorated because the active ingredient is established, the dosage form is relatively simple, generic alternatives are available, and no current brand-specific patent or regulatory exclusivity appears to protect the product in the United States. Pediapred-specific revenue is not publicly disclosed. The economic opportunity is concentrated in generic prednisolone oral solutions rather than in the Pediapred brand.

What is Pediapred and what drug does it contain?

Pediapred is an oral liquid formulation of prednisolone sodium phosphate, a corticosteroid used for inflammatory and allergic conditions. The product has historically been marketed in pediatric-oriented oral solution strengths, including formulations equivalent to 5 mg and 15 mg of prednisolone per 5 mL, depending on product presentation and market labeling.

Prednisolone sodium phosphate is a water-soluble prodrug that is converted to prednisolone in the body. Its liquid formulation is used when patients cannot swallow tablets or require weight-based dosing.

Attribute	Pediapred
Active ingredient	Prednisolone sodium phosphate
Therapeutic class	Systemic corticosteroid
Dosage form	Oral solution
Primary use	Inflammatory, allergic, and immune-mediated conditions
Patient segment	Pediatric and adult patients requiring liquid dosing
U.S. regulatory pathway	Prescription drug
Reference application	NDA 018722 is associated with Pediapred labeling
Current commercial position	Legacy brand with generic substitution pressure
Biosimilar relevance	None; prednisolone is a small-molecule drug

The product is not a biologic and does not face biosimilar competition. Its direct competitors are generic prednisolone sodium phosphate oral solutions and other systemic corticosteroids, including prednisolone tablets, prednisone liquids, dexamethasone solutions, and methylprednisolone products.

What is the FDA and Orange Book status of Pediapred?

Pediapred’s FDA status is best understood as a legacy prescription product with limited current brand importance. FDA labeling and product databases identify Pediapred as prednisolone sodium phosphate oral solution. The product has been subject to historical labeling updates, but its commercial value is now driven by the molecule and dosage form rather than by brand differentiation.

The FDA Orange Book distinguishes between approved applications, reference-listed drugs, patents, exclusivity, and current marketing status. For Pediapred, the key commercial points are:

1. No meaningful current period of FDA exclusivity protects the brand.
2. No active Pediapred-specific Orange Book patent estate is apparent from the publicly available listing associated with the product.
3. Generic prednisolone sodium phosphate oral solutions can compete through abbreviated new drug applications when they demonstrate pharmaceutical equivalence and bioequivalence.
4. Historical approval does not create ongoing market exclusivity.

FDA records can continue to display a discontinued or previously approved brand even after the product loses commercial relevance. A listing in Drugs@FDA or the Orange Book does not establish that the brand remains actively marketed.

Was Pediapred discontinued?

Pediapred has been treated by the market as a legacy or discontinued brand, while generic prednisolone sodium phosphate oral solutions remain available. Discontinuation status can vary by National Drug Code, manufacturer, package size, and reporting period. The discontinuation of a branded presentation does not eliminate generic supply of the same active ingredient.

The commercial distinction is important. A product can remain approved while the branded version is no longer actively sold, or while particular package sizes have been discontinued. FDA discontinuation records therefore should not be interpreted as evidence that prednisolone sodium phosphate oral solution has left the market.

What patents protect Pediapred?

No current, commercially meaningful Pediapred patent estate is evident from the principal FDA patent and exclusivity sources. The product’s protection has historically depended on regulatory approval, trademark recognition, manufacturing know-how, and prescription demand rather than on a durable composition-of-matter or formulation patent.

Protection category	Pediapred position
Composition-of-matter patent	No commercially relevant active patent identified
Formulation patent	No active Pediapred-specific patent identified
Method-of-use patent	No active Pediapred-specific method patent identified
Orphan-drug exclusivity	Not applicable
New chemical entity exclusivity	Expired
Pediatric exclusivity	No current exclusivity identified
Trademark protection	Potentially available, but weak without active brand distribution
Manufacturing know-how	Possible, but not publicly quantifiable

Prednisolone sodium phosphate is an old corticosteroid ingredient. Any original composition or approval-related exclusivity would have expired long before the current generic market developed.

What formulations are protected by Pediapred patents?

No currently material formulation patent has been identified for the Pediapred oral solution. The formulation is technically manageable compared with complex emulsions, depot injections, inhaled devices, liposomal products, or biologics.

Potential manufacturing considerations include:

• Maintaining chemical stability in an aqueous solution.
• Controlling pH and preservative performance.
• Achieving consistent concentration across shelf life.
• Managing taste and palatability.
• Preventing microbial contamination.
• Meeting container-closure and dosing-device requirements.

These factors can create quality and supply barriers, but they do not appear to create a significant legal barrier to generic entry.

When did Pediapred lose exclusivity?

Pediapred’s practical exclusivity ended years ago. The active ingredient prednisolone sodium phosphate is an established corticosteroid, and generic competition is consistent with the age of the product and the availability of multiple oral liquid corticosteroid products.

Exclusivity type	Current status
New chemical entity exclusivity	Expired
Five-year Hatch-Waxman exclusivity	Expired
Three-year clinical-investigation exclusivity	No current protection
Pediatric exclusivity	No current protection
Orphan exclusivity	Not applicable
Patent exclusivity	No current material patent identified
Brand exclusivity	Commercially eroded by generic substitution

The relevant economic date is therefore not a single upcoming patent expiry. Pediapred is already in a post-exclusivity, generic-dominated market.

Are there Paragraph IV challenges to Pediapred?

A current Paragraph IV litigation risk appears limited because no active, commercially significant Pediapred patent is evident. Paragraph IV certifications challenge listed patents in an abbreviated new drug application. Without an active Orange Book patent protecting the product, there is little basis for a current brand-versus-generic Paragraph IV dispute.

Historical ANDA filings may have used Paragraph IV, Paragraph III, or Paragraph II certifications depending on the status of any listed patents at the time. Those historical certifications do not create present-day protection for the brand.

Litigation question	Assessment
Current Paragraph IV exposure	Low because no material active patent is identified
ANDA challenge risk	Commercial rather than patent-driven
Automatic 30-month stay	Not a current central risk absent a valid listed patent
Brand injunction risk	Low
Generic launch risk	High where supply and regulatory requirements are satisfied

The main risks for a generic competitor are approval timing, manufacturing validation, product quality, sourcing, and pharmacy contracting. Patent litigation is not the principal barrier.

Which companies compete with Pediapred?

Competition exists at both the product and therapeutic-class levels.

Direct generic competitors

Direct competitors include manufacturers of prednisolone sodium phosphate oral solution. The competitive set can change by package size, concentration, NDC, and temporary supply conditions. Common generic suppliers in the U.S. prescription market have included large generic manufacturers and specialty pharmaceutical companies distributing prednisolone oral solutions under their own labels or through private-label arrangements.

The market is likely to be fragmented at the manufacturer level but concentrated in pharmacy purchasing and wholesaler distribution. A small number of suppliers can influence availability when one manufacturer experiences a shortage or manufacturing interruption.

Therapeutic substitutes

Pediapred also competes with:

• Prednisone oral solution or tablets.
• Dexamethasone oral solution.
• Methylprednisolone tablets or liquid formulations.
• Compounded corticosteroid liquids.
• Injectable corticosteroids in acute-care settings.

Clinical substitution depends on potency, duration of action, indication, patient age, palatability, dosing convenience, and prescriber preference. Prednisolone and prednisone are widely used for pediatric inflammatory and respiratory conditions, while dexamethasone is often selected for longer duration or specific acute indications.

How strong is the Pediapred patent estate?

The patent estate is weak from a commercial defense perspective. The product lacks the characteristics that support a strong late-life patent position:

• The active ingredient is old and broadly genericized.
• The dosage form is an oral liquid rather than a complex delivery system.
• No current composition-of-matter patent is identified.
• No current formulation patent is identified.
• No disease-specific method-of-use exclusivity is identified.
• No biologic manufacturing platform is involved.
• Generic substitution is clinically and regulatorily straightforward.

The remaining defensibility is primarily operational. A supplier may gain temporary advantage through reliable manufacturing, a favored concentration, palatable formulation, pediatric dosing accessories, or dependable inventory. Those advantages can support customer retention but are unlikely to prevent generic entry.

What is Pediapred’s financial trajectory?

Pediapred-specific revenue, gross margin, prescription volume, and market share are not publicly reported in the financial statements of its historical owners. The brand is not generally disclosed as a separate reporting segment, and public company filings do not provide a reliable standalone revenue series.

The financial trajectory is therefore inferred from product-market structure:

Period	Financial trajectory
Initial commercialization	Brand value supported by prescription demand and limited competition
Generic entry period	Pricing pressure and declining branded share
Mature generic market	Lower prices, fragmented supply, reduced brand differentiation
Current market	Limited brand value; value concentrated in generic manufacturing and distribution

The product’s revenue exposure is likely immaterial to the consolidated results of a large pharmaceutical company. Historical corporate transactions involving owners or distributors cannot be used to assign a standalone Pediapred valuation unless the parties separately disclosed brand-level sales, which they have not done in the public materials reviewed.

What drives current revenue?

Current revenue associated with prednisolone sodium phosphate oral solution is driven by:

1. Prescription volume for pediatric and adult liquid corticosteroid therapy.
2. The number of approved suppliers.
3. Generic reimbursement and pharmacy purchasing contracts.
4. Product availability by concentration and package size.
5. Temporary shortages or manufacturing disruptions.
6. The use of compounded alternatives when commercial liquid supply is constrained.

Brand pricing power is limited. The most defensible commercial position belongs to suppliers that can deliver consistent quality, maintain inventory, and secure wholesaler and institutional contracts.

What manufacturing and intellectual-property barriers exist?

Manufacturing barriers are modest but not zero. Oral corticosteroid solutions require validated control of potency, impurities, microbial quality, preservative systems, and stability. Pediatric products also face practical demands involving taste, dosing accuracy, and administration convenience.

The principal barriers are:

• FDA-compliant liquid manufacturing capacity.
• Reliable active pharmaceutical ingredient sourcing.
• Stability data across intended shelf life.
• Packaging and dosing-device qualification.
• Control of microbial and particulate contamination.
• Ability to maintain supply during demand spikes.
• Commercial access to wholesalers and retail pharmacies.

These barriers can affect market share and short-term pricing. They do not resemble the barriers associated with sterile injectables, inhaled products, extended-release systems, or biologics.

What generic launch scenarios exist for Pediapred?

The most likely generic-market scenarios are:

Base case: continued low-price generic supply

Multiple manufacturers continue supplying prednisolone sodium phosphate oral solution. The brand remains commercially marginal, with pricing determined by payer reimbursement and wholesaler contracts.

Supply-constrained case: temporary price improvement

A manufacturing disruption or shortage reduces the number of available suppliers. Remaining manufacturers may gain volume and improve net pricing temporarily. Such gains would depend on duration and would not establish durable exclusivity.

Brand-revival case: limited commercial relaunch

A company could relaunch Pediapred or a similar branded product with improved packaging, flavoring, dosing devices, or distribution. The absence of strong patent protection would make a relaunch dependent on marketing and supply execution rather than legal exclusivity.

Compounding substitution case

Pharmacies may compound prednisolone liquids when commercial products are unavailable or when a particular concentration or flavor is required. Compounding can limit the upside of a commercial product during supply shortages.

What litigation or settlement agreements affect Pediapred?

No major current Pediapred patent litigation or settlement agreement is identified as a material driver of market access. The product’s competitive history is more consistent with ordinary generic entry than with a delayed-entry settlement.

There is no evident current litigation structure involving:

• An active Orange Book patent;
• A 30-month stay affecting a major ANDA;
• An authorized generic launch agreement;
• A reverse-payment settlement;
• A continuing injunction against generic prednisolone sodium phosphate solution.

Any historical disputes involving prednisolone products would need to be separated from current Pediapred economics because older litigation may concern different formulations, manufacturers, or regulatory applications.

How does Pediapred compare with competing corticosteroids?

Product or class	Main advantage	Main limitation relative to Pediapred
Generic prednisolone sodium phosphate solution	Direct therapeutic and dosage-form substitute	Limited brand differentiation
Prednisone tablets	Low cost and broad availability	Poorer fit for patients needing liquid dosing
Dexamethasone solution	Longer duration and different clinical profile	Not interchangeable on a milligram-for-milligram basis
Methylprednisolone	Established systemic corticosteroid option	Different potency and dosage form availability
Compounded prednisolone liquid	Customized concentration or flavor	Variable availability and pharmacy-dependent supply

Pediapred’s strongest remaining commercial attribute is its historical recognition as a pediatric liquid corticosteroid. That recognition is weak against generic substitution and does not support premium pricing without active distribution and promotional investment.

What is the outlook for Pediapred?

Pediapred has limited strategic value as a standalone branded asset. Its patent and exclusivity position does not provide a credible barrier to generic competition. The relevant opportunity lies in the broader prednisolone oral-solution market, where manufacturing reliability and distribution access can produce modest recurring revenue.

Potential acquisition value would depend on:

• Whether the brand remains actively marketed;
• The availability of transferable regulatory rights;
• Existing wholesaler and pharmacy contracts;
• Product-specific supply history;
• Revenue by NDC and package size;
• Manufacturing cost and gross margin;
• Any unresolved FDA compliance issues.

Absent those commercial assets, a Pediapred transaction would likely have little value beyond a trademark, legacy regulatory file, or product-line fit.

Key Takeaways

• Pediapred is a legacy prednisolone sodium phosphate oral solution brand.
• The product is a small molecule and has no biosimilar exposure.
• Current brand-specific patent and exclusivity protection is not evident.
• Paragraph IV litigation is not the principal market risk.
• Generic prednisolone oral solutions are the primary commercial competitors.
• Standalone Pediapred revenue is not publicly disclosed.
• The product’s financial trajectory is consistent with brand erosion, generic substitution, and lower pricing.
• Manufacturing reliability, product availability, and wholesaler access matter more than intellectual property.
• The broader prednisolone liquid market may have recurring generic value, but Pediapred itself has limited standalone strategic value.

FAQs about Pediapred patent expiry, generics, and market value

Is Pediapred still sold in the United States?

Pediapred is generally treated as a legacy or discontinued branded product, while generic prednisolone sodium phosphate oral solutions remain available. Product availability can vary by manufacturer, NDC, concentration, and package size.

Can a generic manufacturer launch prednisolone sodium phosphate oral solution without a Pediapred license?

Yes. A generic manufacturer generally does not need a Pediapred trademark or brand license to market an approved equivalent product. It must obtain FDA approval and satisfy applicable pharmaceutical-equivalence, bioequivalence, quality, labeling, and manufacturing requirements.

Does Pediapred have a pediatric exclusivity period?

No current pediatric exclusivity period is identified. Any historical pediatric exclusivity associated with the product would have expired.

Is prednisolone sodium phosphate oral solution a difficult product to manufacture?

It is less complex than sterile injectables, inhaled systems, biologics, or extended-release products. The principal technical issues are stability, microbial control, preservative performance, taste, packaging, and dosing accuracy.

Could Pediapred regain market share through relaunch?

A relaunch could regain limited share through supply reliability, pediatric-friendly packaging, flavoring, or contracting. It would not benefit from a strong patent barrier and would face established generic competition.

References

1. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

3. U.S. Food and Drug Administration. (n.d.). Pediapred: Prednisolone sodium phosphate oral solution prescribing information. Drugs@FDA.

4. National Library of Medicine. (n.d.). DailyMed: Prednisolone sodium phosphate oral solution drug labeling. https://dailymed.nlm.nih.gov/

5. Eisai Co., Ltd. (2008). Annual report and corporate materials describing the acquisition of MGI Pharma, Inc. Tokyo, Japan: Eisai Co., Ltd.

6. U.S. Food and Drug Administration. (n.d.). Generic drugs and abbreviated new drug applications. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drug-facts-0