List of Excipients in Branded Drug DELTASONE

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Generic Drugs Containing DELTASONE

Company	Ingredient	NDC	Excipient
Sonoma Pharmaceuticals Inc	prednisone	69668-220	CELLULOSE, MICROCRYSTALLINE
Sonoma Pharmaceuticals Inc	prednisone	69668-220	LACTOSE MONOHYDRATE
Sonoma Pharmaceuticals Inc	prednisone	69668-220	MAGNESIUM STEARATE
Sonoma Pharmaceuticals Inc	prednisone	69668-220	SODIUM GLYCOLATE

What are the Most Frequently-Used Excipients in DELTASONE?

# Of NDCs	Excipient
1	CELLULOSE, MICROCRYSTALLINE
1	LACTOSE MONOHYDRATE
1	MAGNESIUM STEARATE
1	SODIUM GLYCOLATE

Deltasone Excipient Strategy and Commercial Opportunities for Prednisone Tablets

Last updated: September 24, 2026

Deltasone is the historical brand name for prednisone, an oral corticosteroid. Its commercial value now lies in reformulated prednisone products, differentiated excipient systems, pediatric delivery, and supply reliability rather than brand exclusivity. The original Deltasone product has no meaningful surviving patent moat, and generic prednisone competition limits pricing power.

What is Deltasone and what is its FDA status?

Deltasone is a prednisone tablet marketed historically by The Upjohn Company, later associated with Pharmacia and Pfizer. Prednisone is a synthetic glucocorticoid approved for inflammatory, allergic, autoimmune, hematologic, respiratory, dermatologic, and rheumatic conditions.

Attribute	Deltasone / prednisone
Active ingredient	Prednisone
Drug class	Systemic glucocorticoid
Dosage form	Immediate-release oral tablet
Historical strengths	1 mg, 5 mg, 10 mg, 20 mg, and 50 mg
Regulatory pathway	Original NDA; generic products primarily under ANDA
Current brand position	Historical or discontinued brand; commercial market is predominantly generic
Prescription status	Prescription drug
Biosimilar relevance	None; prednisone is a small molecule
Main competitors	Generic prednisone tablet manufacturers
Primary commercial constraint	Extensive generic substitution and low unit pricing

FDA labeling for historical Deltasone tablets identifies inactive ingredients including lactose, magnesium stearate, starch, and sucrose, although excipient composition can vary by strength, manufacturer, market, and manufacturing revision.[1]

The relevant commercial product today is therefore not the Deltasone brand but a prednisone product that offers a meaningful advantage in tolerability, administration, supply, dosage flexibility, or channel economics.

What excipients are used in Deltasone and generic prednisone tablets?

The historical Deltasone formulation uses a conventional compressed-tablet platform. Lactose functions primarily as a diluent, starch supports powder processing and disintegration, magnesium stearate acts as a lubricant, and sucrose contributes to tablet structure and palatability.

Historical Deltasone excipient profile

Excipient	Functional role	Commercial implication
Lactose	Diluent and filler	Creates an exclusion opportunity for patients with lactose intolerance or customers seeking lactose-free products
Starch	Binder, disintegrant, or filler depending on grade and process	Supports low-cost conventional tableting
Magnesium stearate	Lubricant	Can affect dissolution, blending, and powder-flow performance if overused
Sucrose	Filler, binder, or taste modifier	May be undesirable in sugar-restricted products
Film-coating materials, where used	Appearance, swallowability, protection	Can support product differentiation but add process cost

Exact excipient lists should be taken from the approved label for the specific product and strength. Generic prednisone manufacturers do not necessarily use the Deltasone excipient system.

What excipient strategy is most attractive for prednisone?

A commercial excipient strategy should focus on a defined patient or procurement problem. Replacing excipients without improving use, tolerance, manufacturability, or supply economics is unlikely to support a premium.

Lactose-free prednisone

A lactose-free formulation is the clearest differentiation path. Lactose is common in immediate-release tablets, but many patients and institutions prefer products without lactose because of intolerance, dietary requirements, or formulary policy.

Potential substitutes include:

• Microcrystalline cellulose
• Mannitol
• Dibasic calcium phosphate
• Pregelatinized starch
• Croscarmellose sodium
• Crospovidone
• Low-substituted hydroxypropyl cellulose

Mannitol and microcrystalline cellulose can provide a balanced combination of compressibility and acceptable mouthfeel. Dibasic calcium phosphate can improve tablet hardness but may require careful compatibility and disintegration control.

Sugar-free prednisone

A sucrose-free or sugar-free formulation has potential in pediatric, diabetic, long-term corticosteroid, and institutional markets. The opportunity is stronger when the product is paired with a taste-masking strategy or an oral-dispersible presentation.

Sugar-free positioning alone is unlikely to justify a major price premium for standard swallowed tablets. It becomes more valuable in:

• Pediatric formulations
• Oral liquids
• Chewable tablets
• Orally disintegrating tablets
• Hospital and specialty-pharmacy procurement

Low-allergen and dietary-positioned formulations

Manufacturers can differentiate through excipient declarations such as:

• Lactose-free
• Sucrose-free
• Gluten-free, when supported by controls and testing
• Dye-free
• Titanium-dioxide-free
• Preservative-free for liquid products
• Vegan-compatible, depending on excipient source

These claims require disciplined supplier qualification, cross-contamination controls, and label substantiation. They can improve formulary acceptance but do not create patent exclusivity by themselves.

What formulations are protected or commercially differentiable?

The historical Deltasone tablet has limited formulation differentiation. The strongest opportunities involve new dosage forms or excipient combinations that solve administration or adherence problems.

Immediate-release tablets

This is the most crowded category. A conventional prednisone tablet with a different filler or lubricant usually has limited commercial defensibility. The product can compete on:

• Reliable supply
• Low cost
• Broad strength range
• Scoring accuracy
• Smaller tablet size
• Better swallowability
• Consistent dissolution
• Simplified excipient profile

A standard immediate-release formulation generally has the lowest regulatory and development risk but also the lowest margin potential.

Orally disintegrating tablets

An orally disintegrating prednisone tablet could target patients who have difficulty swallowing, including children, older adults, and patients receiving corticosteroids during acute illness.

Key formulation issues include:

• Prednisone dose loading
• Taste masking
• Mechanical strength
• Moisture sensitivity
• Rapid disintegration
• Packaging protection
• Dose uniformity at low strengths

Orodispersible delivery may support a 505(b)(2) strategy if the product differs materially from approved immediate-release tablets. If the formulation remains pharmaceutically equivalent to a reference product and meets ANDA requirements, an ANDA may be possible. The regulatory pathway depends on dosage form, formulation, labeling, and bioequivalence.

Oral liquid or powder for reconstitution

Prednisone liquids can address pediatric and dysphagia markets. The principal excipient strategy involves:

• Suspending agents
• Wetting agents
• Buffers
• Sweeteners
• Flavors
• Preservatives
• Container-closure compatibility

A preservative-free product can be attractive for selected patient populations but creates greater microbiological and packaging demands. Stability, sedimentation, redispersibility, and dose-measurement accuracy are central development risks.

Modified-release prednisone

Modified-release delivery is technically more differentiated but faces a higher regulatory burden and uncertain clinical demand. Corticosteroid chronotherapy has been studied, but a modified-release product would need a clear clinical or pharmacokinetic rationale, not merely a new excipient matrix.

Potential technologies include:

• Hydrophilic polymer matrices
• Multiparticulate beads
• Enteric coatings
• Delayed-release capsules
• Pulsatile-release systems

These products may support a 505(b)(2) application if they establish a clinically relevant difference from immediate-release prednisone. Development economics are less attractive than for a simple lactose-free tablet unless the product targets a defined specialty market.

How strong is the Deltasone patent estate?

The Deltasone patent estate is commercially weak. Prednisone was discovered and commercialized decades ago, and composition-of-matter protection has long expired.

Patent category	Current commercial relevance
Prednisone composition of matter	Expired
Historical Deltasone formulation patents	Expired or commercially irrelevant
Historical manufacturing patents	Expired or nonblocking
Method-of-use patents for conventional prednisone indications	Generally not a meaningful barrier to generic entry
New excipient combinations	Potentially patentable if novel and non-obvious
New dosage forms	Potentially patentable and potentially eligible for regulatory exclusivity
Manufacturing process improvements	Potentially patentable, but often difficult to enforce against routine generic production

A new patent could cover a specific excipient ratio, particle-size distribution, coating architecture, stability profile, manufacturing process, or delivery system. Patent value would depend on whether the claim covers a clinically useful and difficult-to-design-around formulation.

A patent directed only to replacing lactose with another filler would face substantial validity and obviousness risk unless the formulation produces an unexpected result, such as improved dissolution at a high drug load, superior stability, or a clinically meaningful tolerability advantage.

What is the Orange Book status of Deltasone?

Deltasone should not be treated as a protected Orange Book brand. The commercial regulatory landscape is driven by approved generic prednisone products and their reference-listed-drug relationships.

For a new prednisone product, the relevant questions are:

1. Is the product pharmaceutically equivalent to an existing reference-listed drug?
2. Can it qualify for an ANDA?
3. Does the new dosage form require a 505(b)(2) application?
4. Are any patents listed for the reference product?
5. Does the formulation support separate patent claims or regulatory exclusivity?

Because prednisone is an old small molecule with extensive generic availability, a conventional product would not normally receive new chemical entity exclusivity. A new dosage form may qualify for limited regulatory benefits only if the FDA application meets the applicable statutory requirements.

When does Deltasone lose exclusivity?

Deltasone lost practical market exclusivity many years ago. Prednisone is an established generic drug, and the original brand-era patent and regulatory protections are not credible barriers to generic entry.

There is no meaningful modern exclusivity date that would protect a conventional Deltasone-equivalent tablet. Generic manufacturers can compete through ANDA filings, subject to FDA approval, applicable certifications, manufacturing compliance, and any valid listed patent.

Paragraph IV challenges

Paragraph IV litigation is unlikely to be strategically important for the historical Deltasone brand itself. A Paragraph IV certification becomes relevant when an ANDA applicant challenges a patent listed for a current reference product.

For a newly developed prednisone formulation, Paragraph IV exposure would arise only if:

• The product references an approved drug with listed patents;
• The ANDA applicant makes a Paragraph IV certification; or
• A 505(b)(2) applicant seeks approval before expiration of a listed patent.

The principal litigation risk for a new prednisone product would more likely involve the formulation patent owner challenging an ANDA applicant than a generic company challenging an old Deltasone patent.

Which companies are challenging Deltasone?

No meaningful branded-company challenge is required to enter the conventional prednisone market. Competition comes from generic manufacturers that have obtained or seek FDA approval for prednisone tablets and liquids.

The competitive field typically includes large generic companies, specialty generic manufacturers, contract manufacturers, and regional suppliers. Exact supplier participation varies by dosage strength, presentation, shortage status, and time period. The relevant commercial data are the FDA Orange Book, Drugs@FDA approvals, FDA shortage records, and private prescription databases.[2-5]

What generic entry risks exist for a new prednisone product?

Generic entry risk is high for a conventional immediate-release tablet.

Product concept	Generic entry risk	Commercial outlook
Standard prednisone tablet	Very high	Low margin, volume-driven
Lactose-free tablet	High	Moderate niche value
Sugar-free tablet	High	Moderate institutional and pediatric value
Dye-free or simplified-excipient tablet	High	Useful procurement differentiator
Orally disintegrating tablet	Moderate to high	Better differentiation if taste and stability are solved
Pediatric liquid	Moderate	Potentially attractive in specialty channels
Modified-release prednisone	Moderate	Higher development cost and clinical risk
Patient-specific compounded product	Lower direct generic competition	Limited scale and regulatory complexity

A new product should avoid reliance on a patent that covers only a routine substitution of one common excipient for another. The strongest strategy combines formulation claims with manufacturing know-how, supply contracts, device or packaging differentiation, and channel access.

What are the main commercial opportunities for prednisone excipients?

Hospital and institutional procurement

Hospitals may value products with:

• Reliable supply
• Multiple strengths
• Accurate tablet scoring
• Simplified inactive-ingredient profiles
• Easy pharmacy substitution
• Competitive contract pricing

Supply reliability can be more valuable than minor formulation novelty in a low-cost corticosteroid category.

Pediatric and dysphagia markets

This is the most defensible customer segment. Pediatric patients often need liquid, dispersible, or low-dose presentations. A product with validated taste masking, accurate dose measurement, and stable packaging can obtain better channel positioning than a standard tablet.

Chronic corticosteroid users

Long-term prednisone users may benefit from lactose-free, dye-free, small-size, or easy-to-split tablets. The commercial opportunity is constrained by generic pricing, but specialty pharmacy and direct-to-consumer differentiation can support a targeted product.

International markets

Excipient preferences differ by geography. European and selected Asian markets may place greater emphasis on lactose-free, sugar-free, titanium-dioxide-free, or particular dietary claims. International commercialization requires separate assessment of:

• National reference products
• Local bioequivalence rules
• Excipient restrictions
• Pediatric labeling
• GMP and serialization requirements
• Reimbursement and tender pricing

A global formulation can reduce complexity, but the optimal excipient system may differ by market because of local regulatory and procurement requirements.

What manufacturing and IP barriers matter?

The active ingredient is inexpensive and widely available. The main technical barriers are formulation execution and regulatory documentation.

Important manufacturing controls include:

• Uniform low-dose blending
• Segregation control
• Tablet weight and content uniformity
• Lubrication optimization
• Dissolution across strengths
• Stability under heat and humidity
• Tablet scoring performance
• Packaging moisture protection
• Cleaning validation for corticosteroid potent compounds

Prednisone is potent enough that cross-contamination control matters in multiproduct facilities. Dedicated or rigorously controlled equipment may be necessary depending on the site risk assessment.

The most valuable know-how may be trade-secret process control rather than patent claims. Examples include blend order, granulation endpoint, lubricant mixing time, compression force, coating parameters, and packaging configuration.

How does Deltasone compare with other corticosteroid opportunities?

Drug	Generic competition	Excipient differentiation potential	Commercial attractiveness
Prednisone	Very high	Moderate, strongest in pediatric and lactose-free products	Moderate niche opportunity
Prednisolone	High	Stronger liquid and pediatric opportunity	Moderate
Dexamethasone	High	Strong across liquid, ophthalmic, and injectable forms	Moderate to high by indication
Methylprednisolone	High	Moderate, especially dose-pack and specialty formats	Moderate
Budesonide	High but formulation-dependent	High for inhaled and enteric delivery	Higher technical barrier
Hydrocortisone	High	Strong in pediatric, rectal, topical, and modified-release products	Moderate to high by dosage form

Prednisone is easier to formulate than many advanced corticosteroid products, but its low price and broad generic supply reduce the value of ordinary tablet reformulation.

What revenue exposure should investors and licensors assume?

Deltasone itself should not be modeled as a high-value protected brand. Revenue exposure is concentrated in the generic prednisone market, where profitability depends on:

• Volume
• Manufacturing cost
• Contract pricing
• Shortage conditions
• Number of approved suppliers
• Strength-specific demand
• Hospital versus retail mix

A differentiated pediatric liquid, orally disintegrating tablet, or specialty formulation can support better economics than a conventional tablet. A plain lactose-free tablet is more likely to win formulary preference than premium pricing.

Key Takeaways

• Deltasone is the historical brand for prednisone and has no meaningful surviving brand exclusivity.
• Conventional prednisone tablets are heavily commoditized.
• The historical excipient system includes lactose, starch, magnesium stearate, and sucrose, subject to strength and manufacturer differences.
• Lactose-free, sugar-free, dye-free, pediatric, and dysphagia-oriented formulations offer the clearest commercial opportunities.
• Orally disintegrating and liquid products provide greater differentiation than ordinary tablets.
• New formulation patents must claim a specific, defensible technical combination rather than a routine excipient substitution.
• Paragraph IV litigation is not a central issue for the old Deltasone product but may affect patents covering a new prednisone formulation.
• The best commercial strategy combines excipient differentiation with supply reliability, dosage flexibility, pediatric usability, and channel-specific positioning.
• Prednisone is not a biosimilar opportunity because it is a small molecule.
• The primary business case is niche product differentiation, not recovery of historical Deltasone brand economics.

FAQs

Is Deltasone still commercially available?

Deltasone is primarily a historical brand. Current prednisone supply is dominated by generic manufacturers and alternative prednisone products.

Can a lactose-free prednisone tablet receive patent protection?

Yes, but lactose removal alone is unlikely to support a strong patent. Protection is more credible where the formulation includes a novel excipient system and demonstrates unexpected stability, dissolution, manufacturability, or tolerability benefits.

Is prednisone eligible for new-drug exclusivity?

A conventional prednisone tablet would not receive new chemical entity exclusivity. A novel dosage form may qualify for limited regulatory exclusivity if it meets the statutory requirements for the applicable FDA pathway.

Would a prednisone oral liquid require a 505(b)(2) application?

Not necessarily. The pathway depends on the reference product, dosage form, formulation, labeling, and ability to meet ANDA requirements. A materially different liquid or delivery system may require 505(b)(2) development.

What is the strongest commercial formulation opportunity for prednisone?

A stable, palatable pediatric liquid or orally disintegrating product has greater differentiation potential than a standard immediate-release tablet. A lactose-free tablet is easier to develop but faces stronger generic price competition.

References

1. U.S. Food and Drug Administration. (n.d.). Deltasone (prednisone) tablet labeling. Drugs@FDA.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA database.
4. U.S. Food and Drug Administration. (n.d.). FDA drug shortages database.
5. U.S. Food and Drug Administration. (n.d.). Inactive ingredient database.