List of Excipients in Branded Drug FEVERALL

« Back to Dashboard

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Sun Pharmaceutical Industries Inc	FEVERALL	acetaminophen	51672-2114	GLYCERYL MONOSTEARATE
Sun Pharmaceutical Industries Inc	FEVERALL	acetaminophen	51672-2114	HYDROGENATED PALM KERNEL OIL
Sun Pharmaceutical Industries Inc	FEVERALL	acetaminophen	51672-2114	PEG-100 STEARATE
Sun Pharmaceutical Industries Inc	FEVERALL	acetaminophen	51672-2114	POLYSORBATE 80
Sun Pharmaceutical Industries Inc	FEVERALL	acetaminophen	51672-2115	GLYCERYL MONOSTEARATE
Sun Pharmaceutical Industries Inc	FEVERALL	acetaminophen	51672-2115	HYDROGENATED PALM KERNEL OIL
Sun Pharmaceutical Industries Inc	FEVERALL	acetaminophen	51672-2115	PEG-100 STEARATE

FEVERALL Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: September 24, 2026

FEVERALL is an acetaminophen rectal suppository brand positioned for pediatric and adult fever and pain treatment when oral administration is difficult. Its commercial value depends less on active-ingredient exclusivity and more on suppository-base performance, dose accuracy, pediatric usability, supply reliability, trademark protection, and pharmacy distribution. The core excipient strategy is a nonaqueous fatty base that melts or disperses at rectal temperature and avoids the preservatives, sweeteners, flavors, and aqueous vehicles used in oral acetaminophen products.

What is FEVERALL and how is it regulated?

FEVERALL contains acetaminophen as the active ingredient and is marketed in rectal suppository dosage forms. Public product labeling identifies strengths intended for pediatric and adult use, including 80 mg, 120 mg, 325 mg, and 650 mg presentations, although availability can vary by market and time.

In the United States, acetaminophen products are regulated under the FDA framework for internal analgesic, antipyretic, and antirheumatic products. Acetaminophen is an established OTC active ingredient under the FDA monograph framework, subject to dose, labeling, safety, and dosage-form requirements.[1]

Attribute	FEVERALL position
Active ingredient	Acetaminophen
Route	Rectal
Dosage form	Suppository
Primary indications	Temporary reduction of fever and relief of minor aches and pains
Primary users	Infants, children, adults unable to take oral medication
Regulatory pathway	OTC acetaminophen framework, subject to product-specific labeling and manufacturing compliance
Main commercial differentiation	Rectal delivery, dose availability, ease of use, and supply
Biosimilar relevance	None
Principal competitive substitutes	Oral liquid acetaminophen, chewable tablets, orally disintegrating tablets, ibuprofen products, hospital-administered rectal acetaminophen

FEVERALL is not a biologic, so biosimilar competition does not apply. The relevant competition is from generic or private-label acetaminophen suppositories and from alternative dosage forms.

What excipients are used in FEVERALL suppositories?

FEVERALL labeling identifies a fatty suppository base as the principal inactive component. Depending on the specific product presentation and label revision, the excipient may be described generically as a hard-fat or hydrogenated vegetable-oil-type base rather than by a proprietary chemical name.[2]

The base performs several functions:

1. It maintains physical integrity during storage.
2. It permits insertion without a separate applicator.
3. It melts or softens after administration.
4. It releases acetaminophen into rectal fluid.
5. It reduces the need for preservatives, aqueous solvents, flavors, and sweeteners.

A typical formulation strategy for acetaminophen suppositories uses a lipophilic or semisynthetic hard-fat base. The active ingredient is dispersed through the molten base before molding. Critical formulation parameters include particle size, sedimentation control during filling, mold temperature, cooling rate, suppository weight, and content uniformity.

Why a fatty suppository base is commercially useful

A fatty base supports a compact product with relatively few excipients. That is important for pediatric use because the product avoids oral taste and reduces the risk of refusal caused by bitterness. It also avoids the sugar, flavor systems, suspending agents, and preservatives commonly found in liquid acetaminophen products.

The base must balance two competing requirements:

• It must remain stable during shipping and storage.
• It must soften or melt promptly after rectal administration.

A base with an excessively high melting range may delay drug release. A base with inadequate thermal stability may deform in warehouses, pharmacies, or homes. The commercial formulation therefore depends on a controlled thermal profile rather than merely on the selection of an inexpensive lipid.

What excipient attributes matter most?

Excipient attribute	Commercial and technical effect
Melting range	Controls storage stability and in-use melting
Polymorphic stability	Reduces changes in texture, hardness, and release
Compatibility with acetaminophen	Limits degradation and physical instability
Low moisture content	Reduces hydrolysis and microbial risk
Particle wetting	Improves content uniformity
Low irritation potential	Supports pediatric tolerability
Supply availability	Reduces manufacturing interruptions
Regulatory history	Simplifies quality and regulatory review
Mold release performance	Controls defects and production yield
Oxidative stability	Limits rancidity and odor development

How does FEVERALL’s excipient strategy compare with oral acetaminophen products?

FEVERALL competes with oral products through route-specific performance rather than through the active ingredient. Oral acetaminophen liquids usually require water, sweeteners, flavors, viscosity modifiers, suspending agents, buffers, and preservatives. Tablets may use fillers, binders, disintegrants, lubricants, and coating materials.

Product type	Typical excipient burden	Key patient benefit	Key technical risk
Rectal suppository	Low to moderate	No swallowing or taste requirement	Variable absorption and heat sensitivity
Oral liquid	Moderate to high	Flexible dosing and familiar administration	Taste, dosing errors, preservative and microbial control
Chewable tablet	Moderate	Portable and convenient	Requires chewing and taste acceptance
Immediate-release tablet	Moderate	Low cost and broad availability	Not suitable for patients unable to swallow
Orally disintegrating product	Moderate	Reduced need for water	Still requires oral administration

The rectal route is most valuable when a child is vomiting, unconscious, refusing oral medicine, or unable to swallow. The route is less attractive for routine use because administration may be uncomfortable, culturally unacceptable, or associated with variable absorption.

What formulations are protected by FEVERALL’s patent estate?

The principal commercial protection for FEVERALL is unlikely to come from a currently enforceable composition-of-matter patent. Acetaminophen is an old active ingredient, and the use of fatty suppository bases is established pharmaceutical technology.

The likely protection layers are:

Protection layer	Relevance to FEVERALL
Acetaminophen composition patent	Not commercially relevant because the active ingredient is long established
Suppository-base patent	Possible in theory, but difficult to establish broad exclusivity over conventional fatty bases
Specific manufacturing process	Potentially useful if it produces improved uniformity, stability, or release
Dosage-form patent	Possible for a novel geometry, coating, multilayer structure, or release profile
Method-of-use patent	Limited value for ordinary fever and pain treatment
Trademark	Commercially important for the FEVERALL name
Trade dress and packaging	Useful against confusingly similar OTC products
Manufacturing know-how	Important for thermal control, filling, and content uniformity
Supply agreements	Can create practical barriers even without patent exclusivity

No broad patent monopoly should be assumed merely because a product has a branded name. Patent clearance must distinguish between the FEVERALL trademark, formulation patents, manufacturing patents, and any patents held by third-party excipient suppliers.

Can a competitor copy the formulation?

A competitor could potentially develop an acetaminophen suppository using a different excipient grade, a different fatty base, or a different manufacturing process. The competitor would need to establish:

• Assay and content uniformity;
• Suppository weight uniformity;
• Physical stability;
• Melting or softening behavior;
• Impurity control;
• Acetaminophen release;
• Microbiological quality;
• Packaging compatibility;
• Shelf life under labeled storage conditions.

The absence of a broad active-ingredient patent does not eliminate development risk. Manufacturing defects in suppositories can create batch failures, leakage, cracking, deformation, nonuniformity, or delayed drug release.

When does FEVERALL lose exclusivity?

FEVERALL does not have a conventional small-molecule exclusivity timeline comparable to a newly approved prescription drug. Acetaminophen is an established OTC active ingredient, and ordinary fever and pain indications do not create meaningful use exclusivity.

The commercial exclusivity framework is therefore:

Exclusivity type	Expected importance
New chemical entity exclusivity	None
Orphan-drug exclusivity	None
Pediatric exclusivity	Not a central protection strategy for this established OTC product
Prescription NDA exclusivity	Not the primary commercial basis
OTC monograph access	Allows qualifying competitors to enter without relying on FEVERALL’s brand
Trademark exclusivity	High for brand-name protection
Formulation patent exclusivity	Depends on issued claims and expiration
Trade-secret protection	High for process parameters and supplier controls
Retail placement	Temporary and commercially significant

Generic entry risk is therefore structurally high. A competitor that satisfies the applicable FDA requirements and does not infringe valid formulation or process claims may enter without waiting for FEVERALL’s trademark rights to expire.

What is the Orange Book status of FEVERALL?

The Orange Book is primarily a reference for approved prescription and certain approved nonprescription drug products, therapeutic equivalence evaluations, patents, and exclusivity information.[3] It is not a comprehensive register of every OTC brand, private-label product, or formulation trade secret.

FEVERALL’s commercial protection should not be analyzed as though it has the patent profile of a heavily patented prescription product. Any relevant FDA-listed patent would need to be confirmed by product-specific Orange Book records and applicable FDA patent submissions. The practical competitive assessment is that a conventional acetaminophen suppository has limited Orange Book-based blocking power unless the sponsor has an approved product tied to listed formulation or method claims.

Are there Paragraph IV challenges to FEVERALL?

A Paragraph IV challenge is generally associated with an abbreviated new drug application asserting that a listed patent is invalid, unenforceable, or not infringed. FEVERALL’s principal commercial format does not present the same Paragraph IV profile as a branded prescription tablet with multiple Orange Book-listed patents.

No material Paragraph IV litigation should be presumed without a specific listed patent, ANDA, and court docket. The more likely entry pathway is a competing OTC or generic acetaminophen suppository developed under the applicable FDA framework rather than a high-value Paragraph IV campaign.

What formulation patents could create future FEVERALL value?

A defensible patent strategy would need to cover a technical improvement rather than the basic concept of acetaminophen in a suppository. Potentially valuable claim areas include:

Thermally stable suppository bases

Claims could target a base with improved resistance to softening during shipping while preserving rapid in vivo melting. Data would need to show a meaningful advantage over standard hard-fat systems.

Improved content uniformity

Acetaminophen loading can create manufacturing challenges when particles settle in the molten base. A formulation that maintains uniformity across the filling cycle could support process and composition claims.

Faster or more predictable release

A release-enhancing excipient system, particle treatment, or structured lipid matrix could create a stronger technical position if supported by comparative dissolution or pharmacokinetic data.

Reduced irritation

A low-irritation base or surface treatment could have commercial value in pediatric products. Claims would need tolerability evidence rather than a simple substitution of one conventional fat for another.

Heat-resistant packaging and dosage-form design

Blister materials, barrier films, unit-dose packaging, or a geometry that improves insertion and storage stability may provide narrower but practical protection.

Combination products

A suppository combining acetaminophen with another active ingredient would face substantial regulatory, dosing, safety, and patent issues. The opportunity is larger than for a simple acetaminophen copy, but the development burden is also higher.

What commercial opportunities exist for FEVERALL?

Pediatric rescue dosing

The strongest use case is a child who cannot retain oral medicine. Pediatric caregivers may purchase rectal acetaminophen as a backup product even when oral liquid is the routine treatment.

Hospital and institutional channels

Hospitals, pediatric emergency departments, long-term-care facilities, and ambulance services may value a nonoral antipyretic and analgesic. Institutional buyers prioritize dose accuracy, packaging integrity, shelf life, and uninterrupted supply.

Shortage and supply resilience

A reliable suppository manufacturer can gain share when oral liquid products face manufacturing interruptions, seasonal demand spikes, or pharmacy shortages. Dual sourcing of the fatty base and qualified backup molding capacity can create a commercial advantage.

Private-label licensing

The product may support retailer-branded or pharmacy-branded versions. A manufacturer with validated formulation and production capacity could license the formulation, supply finished product, or provide contract manufacturing services.

Geographic expansion

The route has potential in markets where suppositories are accepted pediatric dosage forms. Regulatory strategy must address local acetaminophen dose limits, packaging requirements, pediatric labeling, and excipient standards. European, Latin American, Middle Eastern, and Asian markets differ materially in route acceptance and OTC classification.

Premium packaging

Unit-dose packaging, child-resistant secondary packaging, clearer strength differentiation, and heat-indicator labeling could support premium positioning. Packaging must prevent mix-ups between 80 mg, 120 mg, 325 mg, and 650 mg strengths.

Which companies are challenging FEVERALL?

The principal competitive threat is not necessarily a named patent challenger. It is substitution from:

• Generic acetaminophen suppository manufacturers;
• Private-label pharmacy products;
• Oral liquid acetaminophen brands;
• Chewable and orally disintegrating acetaminophen products;
• Ibuprofen products for age-appropriate patients;
• Hospital suppliers offering alternative rectal or parenteral antipyretics.

A competing suppository can erode FEVERALL sales without challenging a patent if it matches the dose, shelf life, packaging, and pharmacy availability.

What revenue exposure does FEVERALL have?

Publicly reported revenue attributable specifically to FEVERALL is generally not disclosed separately from broader portfolio or private-company sales. The product’s revenue exposure is more likely to be concentrated in pediatric OTC, pharmacy, hospital, and seasonal fever categories than in large prescription-drug markets.

The main commercial variables are:

Revenue driver	Impact
Pediatric fever season	Raises demand during respiratory illness periods
Product availability	Directly affects pharmacy substitution
Number of marketed strengths	Expands addressable patient segments
Retail distribution	Determines consumer access
Insurance reimbursement	Usually less important for OTC purchase
Institutional contracts	Can stabilize volume
Brand recognition	Supports price premium over private label
Manufacturing yield	Determines gross margin
Thermal shipping performance	Controls returns and spoilage

How strong is the FEVERALL patent estate?

The patent estate is likely weak to moderate unless the sponsor owns issued claims directed to a specific base, release technology, process, packaging system, or combination product. The brand’s stronger assets are likely to be:

1. Trademark recognition;
2. Product availability;
3. Dose-specific packaging;
4. Manufacturing know-how;
5. Qualified supplier relationships;
6. Retail and institutional distribution.

A conventional acetaminophen suppository has a high design-around risk. A stronger intellectual-property program would focus on measurable formulation advantages, supported by comparative data against standard hard-fat suppositories.

What generic launch scenarios exist?

Scenario 1: Direct OTC copy

A competitor launches a comparable acetaminophen suppository with conventional excipients and lower pricing. This is the highest-probability erosion scenario.

Scenario 2: Private-label conversion

A major pharmacy or retailer replaces FEVERALL with a store-brand equivalent. Volume may remain in the category while the branded product loses shelf space.

Scenario 3: Supply-constrained market

FEVERALL retains share because competitors cannot validate or scale suppository production. Manufacturing capability becomes the practical barrier.

Scenario 4: Premium differentiated product

A competitor introduces a more heat-stable, faster-releasing, easier-to-administer product. FEVERALL would need packaging, formulation, or route-use advantages to defend price.

Key Takeaways

• FEVERALL’s core product is an acetaminophen rectal suppository built around a fatty or hard-fat suppository base.
• The excipient strategy eliminates oral taste and reduces the need for preservatives, sweeteners, flavors, and aqueous suspension systems.
• The principal formulation risks are heat stability, polymorphism, content uniformity, release, and manufacturing yield.
• Acetaminophen itself provides no meaningful modern composition-of-matter exclusivity.
• Patent value would depend on a specific base, release system, manufacturing process, packaging design, or combination product.
• The commercial moat is more likely to come from trademark, supply reliability, retail access, and validated manufacturing than from broad patent claims.
• Biosimilar risk is irrelevant. Generic and private-label substitution are the principal threats.
• The strongest opportunities are pediatric rescue dosing, institutional supply, private-label manufacturing, and geographic expansion in markets receptive to suppositories.
• A direct generic or private-label launch could occur without a major Paragraph IV dispute if no blocking listed patent applies.

FAQs

Is FEVERALL a generic acetaminophen product?

FEVERALL is a branded acetaminophen suppository product. Its active ingredient is established, and competing manufacturers may develop equivalent acetaminophen suppositories subject to applicable FDA requirements.

Does FEVERALL contain preservatives?

The suppository format uses a nonaqueous fatty base and generally does not require the preservative systems commonly used in aqueous oral liquids. The exact inactive-ingredient statement depends on the specific strength and label version.

Can FEVERALL be reformulated with polyethylene glycol?

A polyethylene glycol base could be evaluated as an alternative to a fatty base. It may improve thermal stability but can change melting, dissolution, local tolerability, hygroscopicity, and release behavior. A reformulated product would require comparative development and regulatory assessment.

Is a suppository base patent enough to block a generic?

Usually not by itself. A broad claim covering a conventional fatty suppository base may face validity and obviousness challenges. Stronger protection requires a specific composition or process with demonstrated performance advantages.

What is the best commercial extension for FEVERALL?

The strongest extensions are likely to be heat-stable formulations, clearer pediatric dose segmentation, unit-dose packaging, institutional packs, and private-label supply. Combination products have higher potential but also materially greater regulatory and safety complexity.

References

1. U.S. Food and Drug Administration. (2022). OTC monograph M013: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. FDA.

2. U.S. National Library of Medicine. (n.d.). DailyMed: FEVERALL acetaminophen suppository labeling. DailyMed.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

4. Code of Federal Regulations. (2024). 21 C.F.R. Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use.

5. United States Pharmacopeia. (2024). USP-NF general chapters for suppositories, dosage-unit uniformity, dissolution, and pharmaceutical excipients. U.S. Pharmacopeial Convention.