DELTASONE Drug Patent Profile

When do Deltasone patents expire, and what generic alternatives are available?

Deltasone is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in DELTASONE is prednisone. There is one drug master file entry for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Deltasone

A generic version of DELTASONE was approved as prednisone by WATSON LABS on December 31^st, 1969.

Summary for DELTASONE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	170
Patent Applications:	5,326
DailyMed Link:	DELTASONE at DailyMed

Recent Clinical Trials for DELTASONE

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

Sponsor	Phase
Mayo Clinic	Phase 2
ADC Therapeutics	Phase 2
Joseph Tuscano	Phase 2

See all DELTASONE clinical trials

US Patents and Regulatory Information for DELTASONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	DELTASONE	prednisone	TABLET;ORAL	009986-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmacia And Upjohn	DELTASONE	prednisone	TABLET;ORAL	009986-007	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmacia And Upjohn	DELTASONE	prednisone	TABLET;ORAL	009986-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmacia And Upjohn	DELTASONE	prednisone	TABLET;ORAL	009986-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmacia And Upjohn	DELTASONE	prednisone	TABLET;ORAL	009986-008	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Deltasone Market Dynamics and Financial Trajectory: Prednisone Brand Analysis

Last updated: August 25, 2026

Deltasone is a legacy brand of prednisone, an oral corticosteroid with broad use across inflammatory, autoimmune, allergic, hematologic, oncologic, and transplant-related conditions. Its commercial value is now tied to the low-cost generic prednisone market rather than to a differentiated branded product. No current standalone Deltasone revenue, market share, or active patent-based premium is publicly disclosed. The brand has limited strategic value compared with newer specialty corticosteroid products and remains exposed to generic substitution, reimbursement pressure, and supply-based competition.

What is Deltasone and who marketed it?

Deltasone is the former brand name for prednisone tablets. Prednisone is an inactive prodrug that is converted in the body to prednisolone, the pharmacologically active corticosteroid. It is available in multiple tablet strengths and is used for conditions including rheumatoid arthritis, asthma, severe allergies, inflammatory bowel disease, lupus, nephrotic syndrome, and selected malignancies.[1]

The historical U.S. product was associated with Pharmacia & Upjohn, which became part of Pfizer. The original branded product is distinct from the many prednisone tablets marketed today by generic manufacturers.

Item	Deltasone / prednisone position
Active ingredient	Prednisone
Dosage form	Immediate-release oral tablets
Therapeutic class	Systemic glucocorticoid
Primary market	U.S. prescription drug market
Current commercial model	Generic-dominated
Biosimilar exposure	None; prednisone is a small-molecule drug
Current branded differentiation	Limited
Standalone Deltasone revenue	Not publicly disclosed
Patent-driven exclusivity	Expired legacy position

Deltasone should not be confused with Rayos, a delayed-release prednisone product marketed by Horizon Therapeutics. Rayos has a different formulation and a separate patent and reimbursement profile.

How large is the Deltasone and prednisone market?

The commercial market is difficult to measure at the Deltasone brand level because prescriptions are generally dispensed under generic prednisone names. Public market reports typically aggregate prednisone with broader corticosteroid categories or report prescription volumes without separating the original brand from generic products.

Prednisone demand is structurally supported by several factors:

• High prevalence of autoimmune and inflammatory disease.
• Continued use in acute care, emergency medicine, and primary care.
• Use in oncology protocols and hematologic conditions.
• Low treatment cost, which supports broad prescribing.
• Periodic substitution for other corticosteroids during supply disruptions.

The market is mature rather than innovation-led. Volume is linked to patient incidence, treatment protocols, and prescribing practice. Revenue growth is constrained by low generic prices and therapeutic substitution with prednisolone, methylprednisolone, dexamethasone, and hydrocortisone.

What drives prednisone demand?

Prednisone demand is more stable than the revenue trajectory suggests. Generic price erosion reduces dollar sales even when prescription volume remains constant.

Demand driver	Commercial impact
Autoimmune disease prevalence	Supports recurring prescriptions
Short-course acute treatment	Generates high prescription frequency but limited duration
Chronic steroid therapy	Supports refill volume but carries monitoring and safety concerns
Oncology and transplant protocols	Creates institutional and protocol-based demand
Generic substitution	Increases volume for generic suppliers while reducing brand revenue
Steroid-sparing therapies	Limits long-term use in some diseases
Safety concerns	Restricts chronic exposure but does not eliminate acute demand

The FDA-approved label identifies significant risks associated with systemic corticosteroids, including infection, adrenal suppression, metabolic effects, osteoporosis, psychiatric effects, and ocular complications.[1] These risks create pressure to limit duration and dose, particularly in chronic inflammatory disease.

What is Deltasone’s financial trajectory?

Deltasone’s financial trajectory is best characterized as a decline from branded-product economics to an undifferentiated generic market. The historical brand likely lost substantial value after generic prednisone became widely available. Current standalone revenue is not reported in Pfizer’s public financial disclosures, and no reliable public source establishes a current Deltasone sales figure.

Revenue trajectory by commercial phase

Period	Commercial condition	Financial effect
Branded period	Deltasone carried product recognition and branded pricing	Higher unit economics
Generic entry period	ANDA-approved prednisone products entered the market	Rapid price and share erosion
Mature generic period	Multiple manufacturers competed on price and supply	Low margins and limited brand value
Current market	Prescriptions are largely managed as generic prednisone	Revenue depends on volume, contracts, and supply position

The principal financial change was not a collapse in clinical demand. It was a shift in who captured the value. Patients continued to require prednisone, but generic manufacturers and pharmacy benefit managers captured most of the economic benefit from lower prices.

Pfizer does not separately report Deltasone revenue in its current segment disclosures. The product is not identified as a material growth driver in the company’s recent annual reports.[2] Any estimate of current Deltasone sales would therefore be speculative.

When did Deltasone lose market exclusivity?

Deltasone’s original small-molecule patent and regulatory exclusivity position expired decades ago. The product has no meaningful current exclusivity based on the historical active ingredient.

Prednisone was approved in the United States long before the modern Hatch-Waxman framework. Generic prednisone products have been approved through abbreviated new drug applications, allowing manufacturers to rely on the reference drug’s established safety and efficacy record while demonstrating bioequivalence.[3]

Exclusivity category	Current Deltasone position
New chemical entity exclusivity	Expired
Original compound patent	Expired
Formulation exclusivity	No commercially important active exclusivity identified
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current commercial relevance
Reference listed drug position	Historical and subject to FDA regulatory status
Current generic protection	None attributable to Deltasone

Because the commercial product is old, patent expiration is no longer the primary competitive issue. Manufacturing economics, distribution contracts, FDA compliance, and supply reliability are more important.

What is the Orange Book status of Deltasone?

The FDA Orange Book identifies approved drug products and certain patent and exclusivity information. A legacy branded product may remain in historical records even when it is no longer actively marketed. FDA records should be reviewed by National Drug Code, application number, and marketing status rather than by brand name alone.[4]

The relevant commercial conclusion is that Deltasone does not have a current Orange Book patent position capable of blocking ordinary generic prednisone competition. Even if a historical reference listing remains visible, it does not create a live branded moat.

Does Deltasone have active formulation patents?

No commercially significant formulation barrier is associated with standard immediate-release Deltasone tablets. The immediate-release prednisone tablet is technically straightforward and has been manufactured by multiple companies.

This differs from modified-release prednisone products. Rayos, for example, was developed as a delayed-release formulation and received FDA approval for rheumatoid arthritis in patients who require dosing at bedtime.[5] Its formulation, release profile, and patent estate are separate from standard Deltasone.

Which companies compete with Deltasone?

The principal competitors are generic prednisone suppliers rather than branded corticosteroid companies. U.S. prednisone tablets have historically been supplied by manufacturers such as Amneal Pharmaceuticals, Hikma Pharmaceuticals, Solco Healthcare, West-Ward Pharmaceuticals, and other FDA-approved generic drug companies, depending on strength, dosage form, and current market status.

Supplier participation changes over time because manufacturers may discontinue products, consolidate portfolios, or experience FDA manufacturing constraints. A manufacturer’s presence in a historical approval record does not necessarily establish current commercial supply.

How does Deltasone compare with Rayos?

Factor	Deltasone / standard prednisone	Rayos
Release profile	Immediate release	Delayed release
Primary value proposition	Low-cost systemic corticosteroid	Timing of corticosteroid exposure
Market status	Generic-dominated	Branded specialty product
Patent relevance	Historical, largely expired	Formulation and method-of-use protection may matter
Pricing	Commodity-oriented	Higher branded pricing
Main commercial risk	Generic price competition	Payer restrictions and generic or therapeutic substitution
Clinical differentiation	Limited	Circadian dosing and delayed-release positioning

Rayos demonstrates that formulation engineering can create a separate commercial segment even when the underlying active ingredient is old. Deltasone lacks that differentiation.

Are there Paragraph IV challenges involving Deltasone?

Paragraph IV litigation is not a material current risk for Deltasone because the relevant original patents are expired or commercially obsolete. Paragraph IV certifications matter when an abbreviated new drug applicant challenges an unexpired patent listed for a reference product. That framework has limited relevance to an old immediate-release prednisone brand without an active patent estate.[3]

The more relevant generic risks are:

1. FDA approval or reactivation by additional suppliers.
2. Contract losses among existing manufacturers.
3. Manufacturing observations or recalls.
4. Price competition among generic distributors.
5. Substitution by other corticosteroids.

The absence of meaningful patent litigation does not eliminate supply risk. It shifts risk from litigation to operations and procurement.

What patent litigation affects prednisone and Deltasone?

No major current patent dispute is central to the standard Deltasone market. Litigation involving prednisone is more likely to concern:

• Modified-release formulations such as Rayos.
• Method-of-use claims for specific dosing schedules.
• Patent litigation between specialty product sponsors and generic applicants.
• Product liability claims involving systemic corticosteroid safety.
• Manufacturing and distribution disputes.

Standard immediate-release prednisone has a low barrier to entry. A challenger generally does not need to overcome a sophisticated delivery-system patent portfolio to enter the market.

How strong is the Deltasone patent estate?

The Deltasone patent estate is weak from a current commercial perspective.

Patent-strength factor	Assessment
Composition-of-matter protection	Expired
Immediate-release formulation protection	Weak or expired
Method-of-use protection	Limited commercial relevance
Manufacturing complexity	Low to moderate
Regulatory switching cost	Low for approved generic suppliers
Litigation leverage	Low
Pricing power	Low
Supply-chain value	Potentially meaningful during shortages

The remaining barriers are operational. Companies with reliable API sourcing, validated manufacturing capacity, FDA-compliant facilities, and pharmacy distribution relationships can compete even without differentiated intellectual property.

What generic entry risks exist for Deltasone?

Generic entry is no longer a future event for Deltasone. It is the established market structure. The relevant risk is continuing erosion of any residual branded demand.

Generic prednisone creates four financial effects:

• Lower average selling prices.
• Higher pharmacy substitution rates.
• Reduced prescriber attachment to the Deltasone name.
• Increased dependence on volume and supply contracts.

For a generic manufacturer, the market can still be attractive if production costs are low and supply is reliable. For a legacy brand owner, the same conditions limit revenue and reduce the return on commercial investment.

What manufacturing and supply barriers affect prednisone?

Prednisone tablets are relatively simple compared with sterile injectables, biologics, or complex oral delivery systems. The API and finished-dose manufacturing process still requires compliance with current good manufacturing practices, validated analytical methods, quality control, and reliable packaging and distribution.

The main barriers are:

• API availability.
• FDA inspection outcomes.
• Batch failures and recalls.
• Capacity allocation.
• Contract manufacturing economics.
• Shortage management.
• Product discontinuation decisions.

These barriers can create temporary pricing opportunities for suppliers when competitors exit. They do not create durable patent-based pricing power.

What is the FDA regulatory status of Deltasone?

Prednisone is an FDA-established active ingredient with extensive clinical use. The FDA-approved reference labeling covers systemic corticosteroid indications and warnings.[1] Standard generic prednisone products are generally approved through the ANDA pathway and must demonstrate bioequivalence to the reference product.[3]

The regulatory environment is mature. New entrants face routine generic-drug requirements rather than clinical development risk associated with a new molecular entity. The largest regulatory risks are facility compliance, product quality, labeling updates, and continued commercial status.

What is the geographic coverage of Deltasone?

Deltasone’s historical commercial significance is primarily U.S.-based. Prednisone is used internationally, but market names, approved strengths, regulatory standards, and distribution arrangements differ by country. The legacy Deltasone brand does not provide a global platform comparable with an actively promoted multinational specialty medicine.

International prednisone markets are generally generic and price sensitive. Local tendering, national reimbursement systems, and manufacturer registration determine commercial access.

What is the outlook for Deltasone revenue?

The base case is continued low or negligible standalone brand revenue, with stable underlying prednisone demand. The market is unlikely to generate meaningful branded growth without a new formulation, delivery system, combination product, or differentiated indication.

Commercial scenarios

Scenario	Market outcome	Financial implication
Base case	Generic prednisone remains widely available	Stable volume, low pricing, minimal Deltasone value
Supply disruption	One or more suppliers exit or face quality problems	Temporary price increases and share shifts
Specialty reformulation	New delayed-release or targeted product gains adoption	Value migrates to differentiated formulation
Steroid-sparing treatment growth	Biologics and targeted therapies reduce chronic steroid use	Lower long-term prednisone volume in selected diseases
Acute-care persistence	Short courses remain common	Sustained prescription demand but limited revenue growth

The key investment conclusion is that prednisone has durable clinical utility but weak branded economics. Deltasone is commercially relevant as a historical product name and reference point, not as a current high-value patent asset.

Key Takeaways

• Deltasone is a legacy brand of prednisone immediate-release tablets.
• The U.S. market is dominated by generic prednisone products.
• No current standalone Deltasone revenue or market share is publicly disclosed.
• Original patent and regulatory exclusivity have expired.
• Deltasone has no meaningful current patent-based defense against generic competition.
• Paragraph IV litigation is not the main risk; manufacturing, supply, and price competition are.
• Prednisone demand is durable, but low prices cap revenue growth.
• Rayos is a separate delayed-release prednisone product with different formulation economics.
• Future value would require differentiated delivery, formulation, or clinical positioning.
• The most credible financial outlook is stable underlying volume with negligible standalone branded growth.

Frequently Asked Questions

Is Deltasone still available in the United States?

Standard prednisone remains widely available from generic manufacturers. The commercial availability of the historical Deltasone-branded product is separate and should be confirmed through current FDA and pharmacy distribution records.

Is Deltasone the same as prednisone?

Deltasone is a historical brand name for prednisone. Generic prednisone tablets contain the same active ingredient, subject to FDA approval and applicable bioequivalence requirements.

Does Pfizer still generate meaningful revenue from Deltasone?

Pfizer does not separately report Deltasone revenue in its current public financial filings. There is no public evidence that the product is a material contributor to Pfizer’s current revenue.

Can a company obtain a new patent on prednisone?

A new patent could potentially cover a novel formulation, delivery system, combination, manufacturing process, or method of use if it satisfies patentability requirements. A patent on the old prednisone molecule itself would not restore expired composition-of-matter protection.

Is prednisone vulnerable to biosimilar competition?

No. Prednisone is a small-molecule drug, so its competitors are regulated as generic drugs rather than biosimilars. Biosimilar risk applies to biologic products, not conventional prednisone tablets.

References

1. U.S. Food and Drug Administration. (n.d.). Prednisone tablets prescribing information. FDA labeling database.

2. Pfizer Inc. (2024). 2023 annual report. Pfizer Investor Relations.

3. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application (ANDA) process. FDA Center for Drug Evaluation and Research.

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

5. U.S. Food and Drug Administration. (2012). Rayos approval letter and prescribing information. FDA Center for Drug Evaluation and Research.