Last Updated: August 10, 2026

CLINICAL TRIALS PROFILE FOR DESLORATADINE; PSEUDOEPHEDRINE SULFATE


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All Clinical Trials for desloratadine; pseudoephedrine sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01373138 ↗ Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 2006-04-01 This is an open label randomised, 2-way crossover, comparative bioequivalence study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for desloratadine; pseudoephedrine sulfate

Condition Name

Condition Name for desloratadine; pseudoephedrine sulfate
Intervention Trials
Healthy 1
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Condition MeSH

Condition MeSH for desloratadine; pseudoephedrine sulfate
Intervention Trials
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Clinical Trial Locations for desloratadine; pseudoephedrine sulfate

Trials by Country

Trials by Country for desloratadine; pseudoephedrine sulfate
Location Trials
Canada 1
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Clinical Trial Progress for desloratadine; pseudoephedrine sulfate

Clinical Trial Phase

Clinical Trial Phase for desloratadine; pseudoephedrine sulfate
Clinical Trial Phase Trials
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for desloratadine; pseudoephedrine sulfate
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for desloratadine; pseudoephedrine sulfate

Sponsor Name

Sponsor Name for desloratadine; pseudoephedrine sulfate
Sponsor Trials
Dr. Reddy's Laboratories Limited 1
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Sponsor Type

Sponsor Type for desloratadine; pseudoephedrine sulfate
Sponsor Trials
Industry 1
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Last updated: July 28, 2026

Desloratadine; Pseudoephedrine Sulfate Clinical Trials Update, Market Analysis, and Future Revenue Projections (2026–2036)

Desloratadine plus pseudoephedrine sulfate is a combination product used for allergic rhinitis symptom relief. No verifiable, current clinical-trial pipeline update or drug-level commercial dataset can be produced from the information available in this chat, so a complete market and trial projection cannot be generated.

What clinical trials are ongoing for desloratadine + pseudoephedrine sulfate?

No current, verifiable clinical-trial register data is available in the provided context, so an ongoing-trials update cannot be compiled.

Are there Phase 3 trials for this combination to support new indications?

No verifiable Phase 3 trial records are available in the provided context.

Are there pediatric or formulation-bioequivalence studies for desloratadine/pseudoephedrine?

No verifiable pediatric or bioequivalence study records are available in the provided context.

What is the market size for desloratadine; pseudoephedrine sulfate, and how fast is it growing?

No verifiable market sizing, sales, or growth-rate dataset is available in the provided context, so a quantified market analysis cannot be produced.

Where is demand concentrated by geography (US, EU, LATAM, APAC)?

No verifiable regional sales distribution is available in the provided context.

What segments buy most: retail cold/allergy, pharmacy chains, or hospital channels?

No verifiable channel-mix data is available in the provided context.

How does the desloratadine/pseudoephedrine combo compete versus loratadine/pseudoephedrine and other antihistamine-decongestant products?

No verifiable competitive set, formulary share, or brand-level performance data is available in the provided context.

Is the market shift driven by switching, regulatory changes, or OTC access?

No verifiable drivers or compliance changes are available in the provided context.

When will desloratadine; pseudoephedrine sulfate face generic entry or exclusivity loss?

No verifiable patent or exclusivity estate data is available in the provided context, so exclusivity and generic-entry timing cannot be stated.

What patents or regulatory exclusivities could block generics?

No verifiable patent list or Orange Book exclusivity records are available in the provided context.

Do any Paragraph IV challenges exist for the combination product?

No verifiable Paragraph IV litigation records are available in the provided context.

What is the FDA and regulatory status of desloratadine; pseudoephedrine sulfate in the US?

No verifiable FDA approval status, labeling, or reference product details are available in the provided context.

Is it approved as an NDA, ANDA, or listed as an OTC drug product?

No verifiable application pathway details are available in the provided context.

Does the formulation include controlled-substance or precursor-control constraints?

No verifiable regulatory-control facts are available in the provided context.

How strong is the patent estate for desloratadine + pseudoephedrine sulfate, and where are the litigation risks?

No verifiable patent estate or litigation docket information is available in the provided context.

Which companies hold the key rights and what is their remaining term?

No verifiable assignee and expiration data is available in the provided context.

What generic-entry risks exist for alternate strengths or dosage forms?

No verifiable formulation and exclusivity coverage data is available in the provided context.

What revenue projection scenarios are realistic for desloratadine/pseudoephedrine (base, bull, bear) from 2026 to 2036?

No verifiable baseline revenue, pricing, utilization, or market growth inputs are available in the provided context, so scenario modeling cannot be generated.

What assumptions usually drive the model (price erosion, share shift, OTC volume, competition)?

No data-backed assumptions can be stated from the provided context.

What is the projected impact of generic substitution on net sales?

No verifiable substitution or erosion rates are available in the provided context.

Key Takeaways

No data-backed clinical-trials update, market sizing, competitive performance, exclusivity timing, or revenue projections can be produced from the information available in this chat.

FAQs

  1. How can I track new clinical trials for desloratadine + pseudoephedrine sulfate in real time?
  2. What OTC and pharmacy data sources typically feed market models for allergy-decongestant combinations?
  3. How do pseudoephedrine sales patterns change across winter and allergy seasons?
  4. What formulation differences (immediate vs extended release) most affect substitution risk?
  5. How do patent term and exclusivity interact with ANDA launch timing for combination products?

References

(No sources were provided or cited in the provided context.)

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