CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE

505(b)(2) Clinical Trials for fexofenadine hydrochloride

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	NCT01469234 ↗	A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)	Completed	Bayer	Phase 4	2011-10-01	The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.
New Dosage	NCT02435563 ↗	Dose Adaptation to Offset the Interaction Between Ticagrelor and Ritonavir by Population-based PK Modeling	Completed	University Hospital, Geneva	Phase 2	2014-08-01	Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks. Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active metabolite. Because of the remarkable progress in HIV therapies the number of older age patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is contraindicated in these patients because of the expected interaction and bleeding risk. A lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of ritonavir has been already demonstrated. Therefore, administration of a lower dose of ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as administered alone using a physiologically-based pharmacokinetic (PBPK) model. As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will be created based on available in vitro and in vivo parameters in healthy volunteers. An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the volunteers and obtained pharmacokinetic data will be fitted into the model for optimization. Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize the magnitude of this interaction will be calculated. This new dose will be co-administered with ritonavir in the same volunteers during the second session of the clinical trial. The purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both sessions of the clinical trial using two specific platelet function tests: the VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as probe substrates. The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to broaden the application field of ticagrelor, especially in HIV patients. Since PK models are often created after clinical observations, the prospective aspect of this study is of particular value as the model will be first created and then applied to an unknown clinical scenario.
OTC	NCT03425097 ↗	Fexofenadine Use in Gastroesophageal Reflux Symptoms	Terminated	Stanford University	Phase 2	2018-02-07	The investigators wish to study the effectiveness of Fexofenadine (an over the counter allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still have symptoms despite being on a proton pump inhibitor. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.

All Clinical Trials for fexofenadine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00029692 ↗	Effects of Ginseng and Ginkgo on Drug Disposition in Man	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 2	2002-03-01	This study will assess the effects of ginseng and ginkgo on 1) cognitive function, 2) enzymes that process drugs, and 3) enzymes that may help prevent cancer.
NCT00044811 ↗	Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma	Completed	Sanofi	Phase 3	2002-03-01	The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma
NCT00044824 ↗	Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma	Completed	Sanofi	Phase 3	2002-02-01	The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma
NCT00045955 ↗	Long-Term Safety Performance of Fexofenadine in Asthma	Completed	Sanofi	Phase 3	2002-02-01	The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma

Clinical Trial Conditions for fexofenadine hydrochloride

Condition Name

Condition Name for fexofenadine hydrochloride
Intervention	Trials
Healthy	16
Seasonal Allergic Rhinitis	9
Allergic Rhinitis	7
Healthy Volunteers	4

Condition MeSH

Condition MeSH for fexofenadine hydrochloride
Intervention	Trials
Rhinitis, Allergic	27
Rhinitis	26
Rhinitis, Allergic, Seasonal	15
Pruritus	6

Clinical Trial Locations for fexofenadine hydrochloride

Trials by Country

Trials by Country for fexofenadine hydrochloride
Location	Trials
United States	68
Australia	9
Canada	7
Switzerland	6
France	5

Trials by US State

Trials by US State for fexofenadine hydrochloride
Location	Trials
New Jersey	10
Kansas	4
Texas	4
California	3
Maryland	3

Clinical Trial Progress for fexofenadine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for fexofenadine hydrochloride
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	4

Clinical Trial Status

Clinical Trial Status for fexofenadine hydrochloride
Clinical Trial Phase	Trials
Completed	61
Recruiting	9
Not yet recruiting	6

Clinical Trial Sponsors for fexofenadine hydrochloride

Sponsor Name

Sponsor Name for fexofenadine hydrochloride
Sponsor	Trials
Sanofi	16
Dr. Reddy's Laboratories Limited	5
Merck Sharp & Dohme Corp.	5

Sponsor Type

Sponsor Type for fexofenadine hydrochloride
Sponsor	Trials
Industry	61
Other	51
NIH	4

Last updated: July 27, 2026

Fexofenadine Hydrochloride Clinical Trials Update, Market Analysis, and Generic/Biosimilar Outlook (2026)

Fexofenadine hydrochloride is a widely used, second-generation antihistamine for allergic rhinitis and chronic idiopathic urticaria. The commercial market is mature and primarily protected by formulation-specific and brand-level patent estates rather than active-ingredient exclusivity. Current clinical-trials activity is focused on incremental product improvements, combination products, pediatric dosing, and formulation or delivery modifications rather than new molecular entities.

What clinical trials are running for fexofenadine hydrochloride right now?

Active clinical trial themes

Clinical development for fexofenadine hydrochloride generally concentrates on:

• Improved oral formulations (faster onset, altered release profiles, taste-masked pediatric formulations)
• Bioequivalence and bridging studies supporting reformulations or generic entries
• Pediatric studies and dosing optimization
• Combination products (e.g., pairing with other OTC or allergy agents)
• Real-world symptom control endpoints used to support labeling or product differentiation

Where to expect trial activity by region

• US/EU: typically Bioequivalence/bridging and pediatric studies tied to product dossiers
• Asia-Pacific: tends to include reformulation and local bridging to support marketing authorization and reimbursement listings
• Global: multi-site studies for combination products and pediatric tolerability

Trial endpoints commonly used

• Total nasal symptom score (TNSS) and individual component symptom scores
• Itch severity and hives count for chronic urticaria
• Pharmacokinetic endpoints for reformulation and BE studies (Cmax, Tmax, AUC)
• Tolerability and adverse event rates

How big is the fexofenadine hydrochloride market, and what segments drive revenue?

Market structure

Fexofenadine hydrochloride is sold under multiple brand and generic names in:

• Over-the-counter (OTC) channels in multiple jurisdictions
• Prescription channels where local reimbursement and clinician preference apply
• Combination SKUs where marketed

Primary revenue drivers:

• Allergic rhinitis seasonality (spring/fall peaks, geographic latitude effects)
• Chronic idiopathic urticaria recurrence and maintenance demand
• Form factor preferences (tablets vs orally disintegrating tablets vs liquid formulations for pediatric use)

Key demand segment buckets

• Allergic rhinitis (AR): dominant volume driver in most markets
• Chronic idiopathic urticaria (CIU): smaller but more stable use pattern
• Pediatric formulations: a smaller revenue share with consistent pipeline activity for dosing convenience

What market projections exist for fexofenadine hydrochloride through 2030?

Base-case projection (mature, competitive generics)

• Growth is expected to track population-level allergic disease prevalence and continued OTC penetration.
• Revenue growth is likely constrained by:
  • Extensive generic availability
  • Price competition and substitution
  • Patent cliffs at the brand formulation level (not active ingredient)

Upside and downside levers

Upside:

• Differentiated OTC positioning (fewer dosing changes, faster onset claims where supported)
• Expansion of pediatric-friendly formulations
• Combination products gaining shelf space

Downside:

• Continued generic erosion in large markets
• Regulatory or labeling changes that shift prescriber or OTC preference to competing antihistamines
• Strong competition from other second-generation antihistamines (e.g., cetirizine, levocetirizine, loratadine, rupatadine where approved)

How do clinical-trial and market dynamics differ for OTC fexofenadine vs prescription products?

OTC products

• Trial activity is usually focused on bridging, palatability, and consumer-relevant endpoints.
• Label expansions are typically incremental.
• Market is more price sensitive and distribution-led.

Prescription products

• Trial activity is more likely to include chronic urticaria-focused endpoints and longer safety follow-up.
• Clinical differentiation often depends on tolerance and symptom control over time, not PK alone.
• Reimbursement and guideline inclusion influence demand.

What patents protect fexofenadine hydrochloride, and when do they expire?

Patent estate reality

For fexofenadine hydrochloride, most “big” exclusivity tied to the active ingredient is long expired in major markets. Practical IP protection is commonly concentrated in:

• Brand-specific formulations (e.g., specific tablet types, release characteristics, or pediatric dosage forms)
• Method-of-use claims (less common at scale, and often limited to specific labeling constructs)
• Manufacturing-process patents (site or process-specific and narrower in scope)

Implication for market

• Generic entry has generally occurred in many markets.
• Remaining exclusivity is usually SKU-specific, not molecule-wide.

Which companies compete in fexofenadine hydrochloride, and how does generic penetration affect pricing?

Competitive landscape

Competition includes:

• Large generic firms with broad OTC portfolios
• Specialty manufacturers with reformulation or pediatric lines
• Brand holders in some geographies where label and distribution support persist

Pricing dynamics

• Fexofenadine is a commodity-like antihistamine in many markets.
• Market share is driven by:
  • Packaging and OTC presence
  • Formulation convenience
  • Pharmacy and wholesaler contracts
  • Local brand loyalty programs

When does fexofenadine hydrochloride lose exclusivity by dosage form?

Dosage-form exclusivity is the main differentiator

For a molecule with broad generic availability, exclusivity timelines are typically tied to:

• Orally disintegrating formulations
• Liquid formulations
• Pediatric-specific strengths and dosing regimens
• Any extended-release or delayed-release variants (where they exist in specific regions)

Practical timeline impact

• Once a formulation-specific patent expires or is no longer enforceable, generics can enter at the SKU level quickly.
• Residual brand share can persist where consumer perception and distribution are strong.

What generic entry risks exist for fexofenadine hydrochloride?

Low-to-moderate legal entry risk (typical)

Given broad historical generic availability, the main entry risks for new generics typically include:

• If targeting a specific differentiated formulation still covered by formulation/process patents
• If pursuing a narrow labeling indication requiring method-of-use protection
• If manufacturing involves a process that is still claimed in enforceable patents

Regulatory entry risks

• Product quality consistency and BE requirements
• Manufacturing controls and inspection outcomes
• Labeling differences that require localized evidence

How does fexofenadine hydrochloride compare with other second-generation antihistamines on efficacy and safety?

Comparative positioning

Across second-generation antihistamines, differentiators often include:

• Onset and symptom control at early timepoints
• Sedation potential (class expectations and labeling)
• Interaction and renal dosing considerations (varies by molecule and labeling)

Market implications

• If competitors deliver similar symptom control at similar or lower prices, switching is common.
• Form factor and convenience often matter as much as pharmacologic differences in OTC settings.

What is the FDA and Orange Book status of fexofenadine hydrochloride?

Orange Book listings

Fexofenadine hydrochloride is widely listed with many generic and ANDA products. For market planning, the relevant question is typically:

• Which specific listed patents still protect a given NDA/label or specific formulation

Why Orange Book search matters for SKU planning

Even when the active ingredient is not protected, product-level patents can cover:

• Composition of matter for specific formulation technologies
• Methods for manufacturing or using a formulation
• Specific strength/route/dosage form constructs

What patent litigation affects fexofenadine hydrochloride?

Typical litigation pattern

For mature antihistamines, litigation usually centers on:

• Paragraph IV disputes tied to remaining formulation or method-of-use patents
• Settlement agreements that delay generic launch for specific SKUs

Market impact

When litigation involves only narrow claims:

• Settlements can preserve brand share only modestly in the near term.
• Generic substitution tends to resume once carve-outs expire.

How do combination products and new formulations change IP and clinical development?

Combination product pathway

Combination products introduce new questions:

• Combination-specific formulation patents
• Stability and dose uniformity patents
• Label-specific evidence for additive benefit claims

Formulation pathway

Formulation changes can create new:

• Patentable compositions or process steps
• New clinical evidence requirements (BE and sometimes bridging)
• New commercial differentiation opportunities

Key Takeaways

• Fexofenadine hydrochloride is a mature antihistamine market with continued clinical activity dominated by formulation, pediatric, and bridging work rather than new molecular entities.
• Market growth through 2030 is likely modest and driven by OTC penetration, convenience formulations, and localized label or distribution advantages rather than breakthrough efficacy.
• Patent protection is largely formulation- and SKU-specific, so exclusivity timelines are best evaluated at the dosage-form level rather than as active-ingredient coverage.
• Generic penetration is extensive; the practical legal risk for new entrants is tied to whether the targeted SKU remains covered by enforceable formulation/process or method-of-use patents.

FAQs

1. Is fexofenadine hydrochloride still protected by patents for any specific dosage forms?
   Patent protection, where present, is generally formulation or SKU-specific rather than molecule-wide.

2. Do clinical trials for fexofenadine hydrochloride usually involve new efficacy claims or mainly bioequivalence?
   Most activity is bioequivalence/bridging and pediatric or formulation-focused, with limited novel efficacy expansion.

3. How does pediatric formulation demand affect the fexofenadine hydrochloride pipeline?
   Pediatric dosing convenience (liquids/ODTs) drives formulation and tolerability studies used for labeling and market access.

4. What is the biggest commercial risk for fexofenadine brands?
   Continued generic pricing pressure and shelf substitution by other antihistamines.

5. How should market forecasts handle seasonality for allergic rhinitis sales?
   Forecasts should incorporate latitude-specific season peaks and OTC promotional calendars, as they drive volume and cadence more than new clinical outcomes.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. U.S. National Library of Medicine.
3. EMA European Medicines Agency. EPAR product information for antihistamines (as applicable by jurisdiction).