ORASONE Drug Patent Profile
Which patents cover Orasone, and when can generic versions of Orasone launch?
Orasone is a drug marketed by Solvay and is included in two NDAs.
The generic ingredient in ORASONE 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 Orasone
A generic version of ORASONE was approved as prednisone by WATSON LABS on December 31st, 1969.
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Questions you can ask:
- What is the 5 year forecast for ORASONE?
- What are the global sales for ORASONE?
- What is Average Wholesale Price for ORASONE?
Summary for ORASONE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 75 |
| Clinical Trials: | 116 |
| DailyMed Link: | ORASONE at DailyMed |
Recent Clinical Trials for ORASONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 2 |
| Joseph Tuscano | Phase 2 |
| ADC Therapeutics | Phase 2 |
US Patents and Regulatory Information for ORASONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Solvay | ORASONE | prednisone | TABLET;ORAL | 083009-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Solvay | ORASONE | prednisone | TABLET;ORAL | 083009-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Solvay | ORASONE | prednisone | TABLET;ORAL | 083009-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Solvay | ORASONE | prednisone | TABLET;ORAL | 083009-003 | Approved Prior to Jan 1, 1982 | 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 |
ORASONE Market Dynamics, Financial Trajectory, Patent Status, and Generic Competition
ORASONE was a legacy brand of prednisone, an oral corticosteroid used for inflammatory, allergic, autoimmune, hematologic, and respiratory conditions. Its commercial trajectory followed the standard lifecycle of an older small-molecule medicine: early brand adoption, loss of exclusivity, substitution by lower-priced prednisone generics, and eventual disappearance as a material branded-revenue product. Public sources do not disclose a standalone current revenue stream for ORASONE. Its economic relevance is now tied to the broader prednisone market rather than to the brand itself.
What is ORASONE and who marketed it?
ORASONE is a brand name associated with prednisone, a synthetic glucocorticoid. Prednisone is converted in the body to prednisolone, the pharmacologically active metabolite. The product was available in oral tablet strengths used for systemic corticosteroid therapy.
Historical references associate ORASONE with Roxane Laboratories and earlier pharmaceutical marketing organizations. Product ownership and distribution changed over time, as was common for legacy prescription brands. The brand was later displaced by generic prednisone products and is not generally treated as a commercially active U.S. brand.
| Attribute | ORASONE |
|---|---|
| Active ingredient | Prednisone |
| Drug class | Systemic corticosteroid |
| Primary dosage form | Oral tablets |
| Typical strengths historically marketed | Multiple strengths, including low- and high-dose tablets |
| Original commercial position | Branded prescription product |
| Current commercial position | Legacy or discontinued brand; generic prednisone dominates |
| Main competitors | Generic prednisone manufacturers |
| Current revenue disclosure | No standalone public revenue disclosure identified |
| Regulatory pathway | Legacy NDA product, followed by ANDA-based generic competition |
The FDA states that a discontinued product designation does not necessarily mean that the product was withdrawn for safety or efficacy reasons. Discontinuation can reflect commercial decisions, manufacturing changes, reformulation, or replacement by other products.[1]
When did ORASONE lose exclusivity?
ORASONE lost meaningful market exclusivity decades ago. Prednisone is an established small molecule with a long clinical history, and the relevant composition-of-matter and early product patents expired before the modern generic market became mature.
No current commercial moat exists around prednisone as an active ingredient. Generic manufacturers can market prednisone after satisfying FDA abbreviated new drug application requirements, including pharmaceutical equivalence, bioequivalence, manufacturing controls, and labeling requirements.
The economically important transition was therefore from a differentiated brand to a multisupplier generic market. Once multiple prednisone manufacturers entered, price competition became the primary market force.
Prednisone exclusivity timeline
| Period | Commercial event | Market effect |
|---|---|---|
| Early branded era | ORASONE and other prednisone brands supplied prescription demand | Brand pricing and physician familiarity supported revenue |
| Patent-loss period | Generic prednisone approvals expanded | Brand substitution began |
| Mature generic period | Multiple manufacturers supplied tablets | Wholesale and pharmacy prices declined |
| Current market | Generic prednisone is the dominant supply source | ORASONE has little or no identifiable standalone market power |
A precise original patent expiration date for ORASONE is not material to current valuation. The product’s exclusivity has been exhausted, and no viable branded exclusivity position is evident in current U.S. market conditions.
What is the FDA and Orange Book status of ORASONE?
ORASONE is not generally treated as an active, actively promoted FDA brand in the current U.S. market. The Orange Book distinguishes between approved products that remain marketed and products listed as discontinued. A discontinued listing does not provide an active commercial franchise.
The FDA’s Orange Book remains the principal source for identifying approved products, therapeutic-equivalence evaluations, and patent or exclusivity information submitted for listed products.[2] For a legacy prednisone brand, the relevant commercial conclusion is that generic prednisone products, rather than ORASONE, determine market availability.
Is ORASONE still FDA-approved?
Historical FDA approval does not mean that a product remains commercially available. A product may retain an approval history while being listed as discontinued or no longer supplied. The practical distinction is important:
- ORASONE has legacy regulatory recognition.
- Current prescriptions are generally filled with generic prednisone.
- Generic prednisone products are approved through abbreviated applications.
- No current brand-led promotional or reimbursement strategy appears to support ORASONE.
How large is the prednisone market?
The prednisone market is broad in clinical use but fragmented by indication, dosage, strength, and treatment duration. Prednisone is prescribed for conditions including:
- Rheumatologic and autoimmune diseases
- Asthma and other respiratory disorders
- Severe allergic reactions
- Dermatologic disease
- Inflammatory bowel disease
- Hematologic disorders
- Transplant-related and immunosuppressive regimens
- Oncology-supportive care
Unlike high-cost specialty drugs, prednisone is usually a low-cost oral product. Demand is driven by prescription volume rather than high revenue per patient. Treatment can be short term, intermittent, or chronic, with duration varying substantially by diagnosis.
Market demand is relatively resilient because prednisone is inexpensive, clinically familiar, and included in standard treatment protocols. Revenue growth is constrained because generic competition keeps prices low and because the drug has no meaningful product differentiation in its standard tablet form.
What is the financial trajectory of ORASONE?
The financial trajectory is a decline from branded revenue to negligible or unreported brand revenue. No public company filing identifies ORASONE as a material current revenue contributor. The brand’s financial history is best analyzed through lifecycle economics rather than through a current revenue forecast.
Financial lifecycle
| Phase | Revenue profile | Principal driver |
|---|---|---|
| Brand launch and growth | Increasing branded sales | Physician adoption and product availability |
| Mature brand period | Stable or gradually declining sales | Established clinical use |
| Generic entry | Rapid erosion in branded volume and price | Therapeutic substitution |
| Late lifecycle | Low or immaterial branded sales | Discontinuation and generic replacement |
| Current state | No identifiable standalone revenue base | Generic prednisone market |
Genericization typically reduces both prescription volume and net price for the originator. Pharmacy substitution, payer formularies, and lower generic acquisition costs accelerate the decline. Any residual ORASONE demand would likely be limited to historical prescribing habits, inventory, formulary exceptions, or isolated international markets.
A current valuation based on ORASONE brand revenue would therefore be inappropriate unless supported by private sales data, an active international license, or a separate product-rights transaction.
What companies compete with ORASONE?
The principal competitors are manufacturers of generic prednisone tablets. Competition is based on price, supply reliability, wholesaler access, dosage strengths, bottle configurations, and regulatory compliance.
Generic suppliers may include large U.S. pharmaceutical companies, specialty generic manufacturers, and contract manufacturers. The competitive set can change because manufacturers enter or exit the market, supply shortages occur, and companies adjust portfolios based on margin.
Competitive factors
- Price: Prednisone is highly exposed to generic price competition.
- Availability: Hospitals, wholesalers, and pharmacies value consistent supply.
- Strength coverage: Manufacturers compete across commonly prescribed tablet strengths.
- Quality compliance: FDA manufacturing compliance affects continued market participation.
- Channel access: National wholesaler and pharmacy contracts influence unit volume.
- Shortage management: Temporary production disruptions can shift share between suppliers.
No branded differentiation gives ORASONE a sustainable advantage against therapeutically equivalent prednisone tablets.
What patent protection covers prednisone and ORASONE?
Prednisone’s original active-ingredient protection is long expired. The legacy brand does not have a commercially meaningful composition-of-matter patent position.
Formulation patents
Standard prednisone tablets are technically mature products. Potentially protectable features could include:
- Modified-release delivery
- Taste-masking systems
- Novel excipient combinations
- Specialized tablet coatings
- Pediatric liquid formulations
- New dose-delivery devices
Those features would require separate patents and regulatory approvals. They would not restore exclusivity to conventional ORASONE tablets. No widely recognized current formulation patent estate creates a meaningful barrier around the historical ORASONE product.
Method-of-use patents
Prednisone has extensive clinical use, but broad treatment methods involving the active ingredient are generally difficult to protect because of the drug’s long history and established medical applications. Any current method-of-use patent would need a narrowly defined indication, dosing regimen, patient population, or treatment combination.
No active method-of-use position is publicly associated with ORASONE as a material commercial asset.
Were there Paragraph IV challenges or patent litigation involving ORASONE?
Paragraph IV litigation is not a current commercial issue for ORASONE. Paragraph IV certifications apply when a generic applicant challenges listed patents for an approved reference product. Because prednisone’s foundational exclusivity expired long ago and the brand is no longer a major active reference product, there is no evident current Paragraph IV litigation risk affecting ORASONE.
Historical ANDA activity may have supported generic entry, but the economic outcome is already established: multiple generic prednisone products are available, and the branded product no longer controls market access.
No current high-value patent litigation, settlement agreement, or launch-at-risk dispute is publicly associated with ORASONE.
What generic entry risks exist for ORASONE?
Generic entry risk has already materialized rather than remaining a forward-looking threat. The relevant risk is continued erosion of any residual brand demand.
| Risk | Current impact |
|---|---|
| Therapeutic substitution | Very high |
| Price erosion | Very high |
| Pharmacy formulary exclusion | High |
| Wholesaler delisting | High |
| Manufacturer supply disruption | Moderate, but affects all suppliers |
| New formulation competition | Low for the legacy brand |
| Biosimilar competition | Not applicable |
Prednisone is a small molecule, so biosimilar regulation does not apply. Competition occurs through generic drug applications, not through the biologics license application pathway.
How does ORASONE compare with modern corticosteroid products?
ORASONE competes poorly against both generic prednisone and newer delivery-specific corticosteroid products.
| Product category | Differentiation | Commercial position |
|---|---|---|
| ORASONE legacy tablets | Minimal | Displaced |
| Generic prednisone tablets | Low cost and broad availability | Dominant |
| Prednisolone products | Alternative active metabolite or formulation | Indication-specific |
| Dexamethasone and methylprednisolone | Different potency and clinical profiles | Therapeutic alternatives |
| Modified-release corticosteroids | Delivery or regimen differentiation | Potential premium niche |
| Injectable corticosteroids | Route-of-administration advantage | Used in acute or specialized settings |
Prednisone remains clinically relevant because of its versatility and low cost. ORASONE, as a legacy brand, does not capture that value unless a current owner retains an active market, license, or geographic distribution right.
What manufacturing and intellectual-property barriers remain?
Manufacturing barriers are operational rather than patent-based. A supplier must maintain validated tablet manufacturing, control content uniformity, meet dissolution specifications, comply with FDA current good manufacturing practice requirements, and maintain reliable active pharmaceutical ingredient sourcing.
The main barriers include:
- FDA inspection and compliance requirements
- Stable prednisone API supply
- Scale-efficient tablet production
- Packaging and labeling compliance
- Quality-system maintenance
- Wholesaler and pharmacy-channel access
- Ability to operate profitably at generic prices
These barriers can create temporary supply constraints but do not create durable exclusivity. A manufacturer with excess capacity or a lower cost base can enter if regulatory requirements are met.
What is the outlook for ORASONE?
ORASONE has no clear path to renewed U.S. brand growth without a new commercial strategy. Possible value would depend on a reformulation, a new delivery system, a geographic relaunch, or a licensing transaction. Conventional prednisone tablets do not provide a credible basis for premium pricing.
The broader prednisone market should remain stable in volume because the drug is embedded in routine care. Revenue growth will likely remain limited, with market value concentrated among efficient generic manufacturers rather than legacy brand owners.
Key Takeaways
- ORASONE is a legacy prednisone brand, not a current high-value branded franchise.
- Prednisone’s original exclusivity has expired, and generic competition is entrenched.
- No standalone current ORASONE revenue stream is publicly disclosed.
- The FDA and Orange Book framework treats the product as a legacy or discontinued brand rather than an active commercial growth product.
- Paragraph IV litigation, biosimilar competition, and patent-settlement risk are not material current issues.
- Generic prednisone manufacturers capture most market volume and commercial value.
- Any residual ORASONE value would depend on private rights, international sales, or a differentiated reformulation.
- The broader prednisone market is clinically durable but financially low margin.
FAQs
Is ORASONE the same as prednisone?
Yes. ORASONE is a historical brand name associated with prednisone oral products.
Can pharmacies still dispense ORASONE?
Most current prescriptions are filled with generic prednisone. Availability of the ORASONE-branded product depends on country, distributor inventory, and historical regulatory status.
Is ORASONE a biologic or biosimilar product?
No. Prednisone is a conventional small-molecule drug. Its competitors are generic products, not biosimilars.
Does ORASONE have active patent protection?
No commercially meaningful active patent estate is associated with the conventional legacy ORASONE prednisone product.
Could ORASONE be relaunched?
A relaunch could occur only through an available product right, regulatory pathway, manufacturing source, and commercial strategy. A conventional tablet relaunch would face severe price competition from generic prednisone.
References
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U.S. Food and Drug Administration. (n.d.). Discontinued drugs. FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms/discontinued-drugs
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U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
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U.S. Food and Drug Administration. (n.d.). Electronic Orange Book frequently asked questions. FDA. https://www.fda.gov/drugs/development-resources/approved-drug-products-therapeutic-equivalence-evaluations-orange-book/electronic-orange-book-frequently-asked-questions
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National Library of Medicine. (n.d.). Prednisone. MedlinePlus. https://medlineplus.gov/druginfo/meds/a601102.html
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U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application ANDA process. FDA. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda/anda-process-genericsresults-in-remainder?
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