CLINICAL TRIALS PROFILE FOR CELESTONE SOLUSPAN

505(b)(2) Clinical Trials for CELESTONE SOLUSPAN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	Edward Kasaraskis	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	University of Kentucky	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.

All Clinical Trials for CELESTONE SOLUSPAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00685880 ↗	Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis	Terminated	Mayo Clinic	N/A	2008-05-01	Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.
NCT01222247 ↗	Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial	Active, not recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2010-10-01	This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT01222247 ↗	Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial	Active, not recruiting	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2010-10-01	This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT01222247 ↗	Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial	Active, not recruiting	The George Washington University Biostatistics Center	Phase 3	2010-10-01	This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT03054610 ↗	Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.	Completed	Universidad Autonoma de Nuevo Leon	Phase 1	2015-01-01	Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in people 40 years of age or older, overweight, sedentary or with intense physical activity. It is caused by the over-stretching of the plantar fascia, which is a band of connective tissue that extends to the base of the phalanges. This produces micro-tears more commonly in its origin in the medial tuberosity of the calcaneus which causes an inflammatory process and pain. This pain usually occurs when the person gets up in the morning after sleeping or after sitting for a long time. That is when the fascia is stretched after being in a contraction position. There are a great variety of treatments for this pathology, of these, one of the most common is the use of intralesional steroids, which a weighing that reduces symptomatology in many cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are extracorporeal shock waves, application of platelet-rich plasma and application of botulinum toxin A intralesional. All of them are accompanied by insoles, night splints and stretching exercises of the Achilles tendon and the plantar fascia. Recent studies have shown that the application of botulinum toxin A intralesional in patients with plantar fasciitis helps to improve the symptomatology to decrease pain in both intensity and presentation time. Decreased inflammation of the plantar fascia has also been demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is applied regularly in the muscles to block the release of acetylcholine in the neuromuscular plaque and obtain its relaxation and not directly in the pain points. We believe that the botulinum toxin can be applied intralesional currently, since there is information that the toxin has analgesic and anti-inflammatory effect and not just muscle relaxation. The aim of our work demonstrate that the use of botulinum toxin A and intralesional stretching exercises is superior to intralesional steroids and stretching trying to establish a safer and less painful therapy avoiding complications prior to the application of steroid application.
NCT03445611 ↗	Parabens Flocculation on the Anti Inflammatory Effects of Corticosteroid Injections for Total Knee Arthroplasty	Withdrawn	Loma Linda University	Early Phase 1	2019-09-15	The purpose of this study is to identify whether corticosteroid use with anesthetics containing preservatives (parabens) reduces clinical effectiveness of the anti-inflammatory agent Up to 100 patients, both male and female, between the ages of 18-89 will be enrolled and randomized into either of the following groups; Group 1: These patients will receive a corticosteroid solution with lidocaine containing parabens. Group 2: These patients will receive corticosteroid solution with paraben free lidocaine.

Clinical Trial Conditions for CELESTONE SOLUSPAN

Condition Name

Condition Name for CELESTONE SOLUSPAN
Intervention	Trials
Osteoarthritis, Knee	2
Pregnancy	1
Pregnancy Outcome	1
Pregnancy Outcomes	1

Condition MeSH

Condition MeSH for CELESTONE SOLUSPAN
Intervention	Trials
Osteoarthritis	2
Osteoarthritis, Knee	2
Fasciitis, Plantar	1
Fasciitis	1

Clinical Trial Locations for CELESTONE SOLUSPAN

Trials by Country

Trials by Country for CELESTONE SOLUSPAN
Location	Trials
United States	17
Mexico	1

Trials by US State

Trials by US State for CELESTONE SOLUSPAN
Location	Trials
California	2
Alabama	1
Minnesota	1
Nevada	1
Kentucky	1

Clinical Trial Progress for CELESTONE SOLUSPAN

Clinical Trial Phase

Clinical Trial Phase for CELESTONE SOLUSPAN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for CELESTONE SOLUSPAN
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for CELESTONE SOLUSPAN

Sponsor Name

Sponsor Name for CELESTONE SOLUSPAN
Sponsor	Trials
Mayo Clinic	1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
National Heart, Lung, and Blood Institute (NHLBI)	1

Sponsor Type

Sponsor Type for CELESTONE SOLUSPAN
Sponsor	Trials
Other	7
NIH	2

Last updated: May 26, 2026

Celestone Soluspan clinical trials update, market analysis, and exclusivity roadmap for betamethasone sodium phosphate + betamethasone acetate

Celestone Soluspan is an injectable, combination betamethasone product (betamethasone sodium phosphate and betamethasone acetate) for corticosteroid indications. The product is widely marketed as a generic-in-practice class therapy, with limited recent, product-specific clinical-trial signal publicly indexed for the combined formulation under the “Celestone Soluspan” brand. Market outcomes and near-term projection are driven more by corticosteroid volume durability, payer coverage, and competition from other betamethasone injectable brands/generics than by brand-specific late-stage pipeline events.

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What clinical trials have reported results for Celestone Soluspan and similar betamethasone injection combinations?

Featured snippet answer: Publicly indexed “Celestone Soluspan” brand-specific trials with modern endpoints are limited; most clinical evidence for betamethasone combinations is older and reflected in broad corticosteroid guidance and regimen use rather than brand-new phase 3 registrational studies for the exact injectable combination.

Where do trials for betamethasone injection combinations usually appear?

Clinical literature and trial registries for betamethasone in obstetrics and inflammatory indications tend to evaluate:

• Antenatal corticosteroids for fetal lung maturation (timing, dosing schedules, outcomes like respiratory distress syndrome)
• Use in musculoskeletal and inflammatory flares (response rates, symptom scores, steroid-sparing regimens)
• Comparisons across corticosteroid types and routes rather than brand-name injectable combination products

Are there ongoing trials explicitly using Celestone Soluspan brand product?

No product-specific, ongoing phase 3/phase 2 registrational programs for “Celestone Soluspan” were identified in the publicly available indexed trial landscape at the level needed for a clean, brand-anchored update. The absence of clearly trackable, modern, brand-coded trials usually means near-term clinical momentum for this therapy is not anchored to a new pivotal study for the brand formulation.

Typical endpoints that matter for market access

Even without brand-coded modern pivotal trials, payers and formularies respond to evidence categories already established for systemic corticosteroids:

• Short-term symptom relief and functional improvement
• Reduced inflammation markers (where applicable)
• For obstetric use, safety and effectiveness endpoints tracked in guidelines

Implication for R&D strategy: If planning a differentiation program for this exact combination injectable, competitive advantage is more likely to come from formulation delivery, concentration/volume utility, labeling expansion, or compliance advantages than from a brand-new efficacy thesis, unless a specific unmet need and endpoint package is targeted.

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What is the latest FDA regulatory status for Celestone Soluspan and where is it listed?

Featured snippet answer: Celestone Soluspan is an FDA-approved injectable corticosteroid combination product; the practical regulatory question for market entry and exclusivity hinges on Orange Book listings and whether Celestone’s relevant patents and exclusivities block or expire for the specific dosage form.

Orange Book listings determine the real exclusivity clock

For brand injectable drugs, exclusivity and patent protection are usually implemented through:

• Listed patents in the Orange Book
• Potential periods of patent exclusivity tied to approval category and supplemental approvals
• Listed use or formulation patents that can affect Paragraph IV opportunities

How to read the regulatory posture for this class

For combination betamethasone injectables, the commercial reality typically looks like:

• Many competing betamethasone injectables have multiple generic routes
• Even when a brand remains on shelves, manufacturing and pricing may shift rapidly due to generic substitution

Implication for a market projection model: Forecasts should treat Celestone Soluspan as a mature, substitution-exposed product unless Orange Book patent coverage for the exact dosage/strength can be confirmed to extend exclusivity meaningfully.

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When does Celestone Soluspan lose exclusivity and what patent expirations matter for generic entry?

Featured snippet answer: Without a confirmed Orange Book patent list and expiration schedule for the exact Celestone Soluspan dosage strengths and NDA, no defensible exclusivity loss timeline can be stated.

What expirations typically control for injectable corticosteroids

When exclusivity is still relevant for a branded injectable corticosteroid, it is usually linked to:

• Composition of matter or combination patents for the active ingredient pairing (betamethasone sodium phosphate + betamethasone acetate)
• Formulation and manufacturing method patents (particle size, suspension properties, stability)
• Listed use patents that can delay certain generic labeling carve-outs

Why a clean timeline requires an Orange Book audit

A single “Celestone” brand may correspond to multiple strengths, presentations, and supplemental product changes that carry different patent sets. A credible exclusivity schedule must map:

• Strength and dosage form
• NDA (or BLA if applicable, typically not for this class)
• Orange Book patent numbers and expiration dates
• Patent type and claim scope
• Any exclusivity (non-patent exclusivity, pediatric, etc.)

Result for business planning: A generic entry forecast that ignores Orange Book granularity is likely to mis-time the risk window.

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What patent estate protects Celestone Soluspan, and how strong is it for the combination injection?

Featured snippet answer: A strength assessment requires specific, itemized Orange Book patent data (numbers, assignees, claim types, expiration dates) tied to Celestone Soluspan’s exact approved strengths.

What to expect in patent estates for combination corticosteroid injectables

Common patent categories encountered include:

• Composition claims covering the combination and ratios
• Suspension or formulation stabilization claims
• Manufacturing process claims for consistent physical attributes (rheology, resuspendability)
• Methods of use claims for approved indications or dosing regimens

Litigation and enforcement patterns

Even when a patent estate exists, enforcement in mature corticosteroid injectables is frequently limited because:

• Multiple equivalent formulations exist in market
• Generics can sometimes design around formulation-specific claims
• Labeling and route differences can avoid use-claim overlap

Decision-grade point: The relative impact on market projections is usually smaller than for specialty biologics or oncology, because the competitive base is broad and substitutions are routine.

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Are there Paragraph IV challenges or ANDA litigation affecting Celestone Soluspan?

Featured snippet answer: A definitive answer depends on identifying filed ANDAs/Paragraph IV notices and district court filings tied to the specific Celestone Soluspan NDA and strengths.

How Paragraph IV risk typically surfaces in this segment

For mature corticosteroid injections, the common entry pattern is:

• ANDA filings after patent windows near end of life
• Carve-outs for labeling use claims
• Settlement agreements that delay “at-risk” launch for a period

What the market cares about

For projection, the key inputs are:

• Date of first potential generic approval
• Whether a “skinny label” approval triggers full substitution
• Whether settlements include market allocation, authorized generics, or launch timing constraints

Business action: A forecast should be tied to the actual notice and settlement record, not to class-level assumptions.

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How does Celestone Soluspan compare with other betamethasone injectable brands and generics?

Featured snippet answer: Celestone Soluspan is a betamethasone combination injectable; competition is typically between other betamethasone injectable products with similar therapeutic class positioning rather than head-to-head brand differentiation based on novel clinical outcomes.

Competitive comparison framework

Market comparisons should be structured around:

• Strengths and volume per vial/syringe
• Resuspension characteristics and handling (important for hospital pharmacy workflows)
• Wholesale acquisition cost positioning and payer formulary tiers
• Availability stability and lot supply
• Labeling scope overlap

Substitution and procurement behavior

Hospitals and group purchasing organizations often choose based on:

• Contract pricing
• Stock availability
• Formulary preference for betamethasone class products
• Pharmacy substitution policies

Projection impact: Even if Celestone retains brand presence, unit demand can migrate to lower-priced alternatives when multiple equivalent injectables are available.

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What market share and revenue drivers are most likely for Celestone Soluspan through the next 3–5 years?

Featured snippet answer: Demand durability for systemic corticosteroids tends to track broad clinical usage and formulary access; for Celestone Soluspan, the main revenue drivers are tender/contract positioning and generic substitution intensity rather than a late-stage pipeline catalyst.

Key commercial drivers to model

• Acute and episodic demand cycles (inflammatory flares, obstetric use schedules)
• Contracting and rebate structures
• Hospital stock practices and substitution rules
• Competitive pricing among betamethasone injectable equivalents
• Manufacturing supply reliability affecting fill-rate and switching behavior

Key risks to model

• Price compression from new generic entrants or authorized generics
• Loss of preferred formulary tier due to rebate renegotiations
• Any labeling restrictions or safety communications affecting volume use patterns
• Patent or exclusivity expiry events tied to Orange Book coverage

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How should a generic entry scenario for Celestone Soluspan be modeled?

Featured snippet answer: Model at least three scenarios: (1) delay due to patent/settlement, (2) partial substitution via labeling carve-outs, and (3) rapid shelf share loss with full-label generic competition.

Scenario structure for projection

1. Delay/settlement: brand maintains share longer; price declines gradually
2. Skinny label: generic captures portions of use where label overlap exists; brand share declines but not fully
3. Full-label competition: accelerated unit decline; brand pricing must align to contract economics

Unit economics levers

• Wholesale acquisition cost and net price movement tied to contract cycles
• Patient mix shifts where obstetric or inpatient procedural use dominates
• Pharmacy reimbursement behavior in different settings (hospital outpatient vs inpatient)

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What is the biosimilar risk for Celestone Soluspan?

Featured snippet answer: Biosimilar risk is not applicable in the typical sense because Celestone Soluspan is a small-molecule corticosteroid injectable, not a biologic.

Substitution risk still applies

The relevant competitive threat is generic ANDA entry and competitive switching among small-molecule betamethasone injectables.

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Key Takeaways

• Celestone Soluspan is a mature betamethasone combination injectable where market outcomes are driven more by substitution and contracting than by brand-specific late-stage clinical trials.
• A defensible exclusivity and generic-entry timeline requires an Orange Book patent-and-exclusivity map tied to the exact NDA, strengths, and presentations; without that mapping, a timeline cannot be stated.
• Generic entry modeling should use scenario-based share and price dynamics centered on formulary and contract behavior, not pipeline catalysts.
• Biosimilar risk is not the right framework; the correct risk framework is ANDA/generic competitive entry and settlement-driven launch sequencing.

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FAQs

1) What indications are associated with Celestone Soluspan in FDA labeling?
2) Do hospitals substitute Celestone Soluspan automatically with other betamethasone injectables?
3) How do Orange Book listed patents typically affect generic approval timing for injectable corticosteroids?
4) What factors drive net price erosion for mature branded injectables versus new generic launches?
5) How should market analysts compare betamethasone injectable strengths and vials for procurement decisions?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed 2026-05-26).
2. ClinicalTrials.gov. Search results for betamethasone and injectable combination queries. (Accessed 2026-05-26).