CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE HIVES

505(b)(2) Clinical Trials for FEXOFENADINE HYDROCHLORIDE HIVES

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 HIVES

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
NCT00103012 ↗	Drug Interactions of Echinacea, Ginseng, and Ginkgo Biloba Taken With Lopinavir/Ritonavir in Healthy Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 4	2005-01-01	This study will examine the interaction of the HIV combination medication lopinavir/ritonavir with the herbal products echinacea, ginseng, and ginkgo biloba. Patients with HIV infection often take herbal products and dietary supplements in addition to their doctor-prescribed medicines to treat the disease, lessen the side effects of anti-viral drugs, and improve their overall well being. Alternative medicines such as these may, however, interfere with the elimination of lopinavir/ritonavir from the body, causing either higher or lower blood levels of these drugs than would be expected. This study will assess in healthy subjects any potential harms of taking echinacea, ginseng, or ginkgo biloba together with lopinavir/ritonavir. Healthy normal volunteers between 18 and 50 years of age may be eligible for this study. Candidates are screened with a history, physical examination, and blood tests, including an HIV test and a pregnancy test for women. Pregnant women are excluded from the study. Participants come to the NIH Clinical Center after fasting overnight for the following procedures: Visits 1 and 2: A catheter (plastic tube) is placed in an arm vein to collect blood samples. After the first sample is drawn, the subject takes 8 mg of midazolam syrup and two fexofenadine tablets. Midazolam is a sedative, and fexofenadine (Allegra) is a medicine used to treat allergies. Subjects are given breakfast an hour after taking the drugs. Blood samples are collected at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 24 hours after taking the drugs to measure blood levels of fexofenadine. An extra sample is collected at the 4-hour mark to measure the midazolam level. The catheter is removed after the 8-hour blood draw and subjects are dismissed home. They return the following morning (visit 2) for the 24-hour blood draw. Visit 3: From 7 to 28 days after visit 1, subjects begin taking lopinavir/ritonavir capsules twice a day by mouth for a total of 29.5 days. On day 15 they return to the clinic for lopinavir/ritonavir blood levels as were done for fexofenadine, except that samples are collected once before breakfast and then at 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after the lopinavir/ritonavir dose. An extra sample is collected for routine tests. The catheter is removed after the 12-hour draw and the subject is dismissed home. The next morning, subjects begin taking one of the following: echinacea 500 mg 3 times a day; ginkgo biloba 120 mg twice a day; or ginseng 500 mg 3 times a day for 28 days. Visit 4: On the last day of taking lopinavir/ritonavir, subjects return to the clinic again for blood level measurements of these drugs as on visit 3, except that the catheter is removed and the subject dismissed home after the 8-hour blood draw. Visits 5 and 6: On the last day of taking the herbal supplement, subjects return to the clinic for repeat measurement of fexofenadine and midazolam levels, as described in visits 1 and 2. At the final visit (visit 6) an additional blood sample is collected for repeat laboratory testing. ...
NCT00261079 ↗	Fexofenadine in Pruritic Skin Disease	Completed	Handok Inc.	Phase 4	2005-04-01	Primary objective: - To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: - To evaluate patient's satisfaction of Allegra treatment
NCT00261079 ↗	Fexofenadine in Pruritic Skin Disease	Completed	Handok Pharmaceuticals Co., Ltd.	Phase 4	2005-04-01	Primary objective: - To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: - To evaluate patient's satisfaction of Allegra treatment

Clinical Trial Conditions for FEXOFENADINE HYDROCHLORIDE HIVES

Condition Name

Condition Name for FEXOFENADINE HYDROCHLORIDE HIVES
Intervention	Trials
Healthy	16
Seasonal Allergic Rhinitis	9
Allergic Rhinitis	7
Healthy Volunteers	4

Condition MeSH

Condition MeSH for FEXOFENADINE HYDROCHLORIDE HIVES
Intervention	Trials
Rhinitis, Allergic	27
Rhinitis	26
Rhinitis, Allergic, Seasonal	15
Pruritus	6

Clinical Trial Locations for FEXOFENADINE HYDROCHLORIDE HIVES

Trials by Country

Trials by Country for FEXOFENADINE HYDROCHLORIDE HIVES
Location	Trials
United States	68
Australia	9
Canada	7
Switzerland	6
France	5

Trials by US State

Trials by US State for FEXOFENADINE HYDROCHLORIDE HIVES
Location	Trials
New Jersey	10
Texas	4
Kansas	4
Maryland	3
California	3

Clinical Trial Progress for FEXOFENADINE HYDROCHLORIDE HIVES

Clinical Trial Phase

Clinical Trial Phase for FEXOFENADINE HYDROCHLORIDE HIVES
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	4

Clinical Trial Status

Clinical Trial Status for FEXOFENADINE HYDROCHLORIDE HIVES
Clinical Trial Phase	Trials
Completed	61
Recruiting	9
Not yet recruiting	6

Clinical Trial Sponsors for FEXOFENADINE HYDROCHLORIDE HIVES

Sponsor Name

Sponsor Name for FEXOFENADINE HYDROCHLORIDE HIVES
Sponsor	Trials
Sanofi	16
Merck Sharp & Dohme Corp.	5
Dr. Reddy's Laboratories Limited	5

Sponsor Type

Sponsor Type for FEXOFENADINE HYDROCHLORIDE HIVES
Sponsor	Trials
Industry	61
Other	51
NIH	4

Fexofenadine Hydrochloride for Hives (Chronic Spontaneous Urticaria): Clinical Trials Update, Market Analysis, and Generic/Biosimilar Exclusivity Projection

Last updated: May 22, 2026

Fexofenadine hydrochloride is an antihistamine used for urticaria and other allergy indications. Clinical-trial activity for “hives” is dominated by formulation, bioequivalence, and comparative efficacy studies, with limited late-stage novelty versus broader antihistamine classes. From an IP and market-access perspective, commercial risk is driven by generic entry and formulary adoption rather than biologics-style exclusivity.

What clinical trials exist for fexofenadine hydrochloride hives, and what do the results show?

Featured-snippet answer: Published evidence supports that fexofenadine improves itch and wheal measures in urticaria, with performance generally competitive versus other second-generation H1 antihistamines in symptomatic endpoints.

Which trial designs have been used in chronic urticaria and “hives” studies?

Across urticaria programs, the most common trial shapes are:

• Randomized, double-blind, placebo-controlled studies measuring itch severity and wheal counts.
• Active-comparator trials versus other second-generation H1 antihistamines.
• Short-cycle efficacy studies (often weeks) with symptom diaries as the primary readout.
• Formulation/bioequivalence studies for tablet, orally disintegrating, or dose-strength variations where clinical endpoints are not the focus.

What endpoints are typically used for hives outcomes?

• Itch (pruritus) score change from baseline
• Wheal count or wheal severity scoring
• Composite symptom scores or patient-reported itch diaries
• Responder definitions (for example, proportion achieving predefined itch reduction)

What is the most relevant clinical narrative for market positioning?

Fexofenadine’s clinical role in hives is best characterized as:

• Symptom control rather than disease modification.
• Competitive efficacy among non-sedating, second-generation antihistamines.
• A relatively stable safety profile aligned with class expectations (sedation and anticholinergic burden are generally lower than first-generation agents).

What is the current state of clinical trial activity for fexofenadine hydrochloride in urticaria?

Featured-snippet answer: Trial activity for fexofenadine in “hives” is largely incremental, with a mix of comparative efficacy and formulation-focused studies rather than a clear late-stage pivot tied to a new mechanism.

How do trial phases map to commercial relevance?

• Phase 2/3: If present, typically supports label expansions or dosing confirmation.
• Phase 1: Usually bioequivalence and PK characterization for new formulations or strengths.
• “Not applicable” trials: Common for OTC-related formulation improvements (PK/BE).

What does this imply for near-term product differentiation?

If ongoing studies are primarily PK/BE or comparative within the class, differentiation will rely on:

• Dosing convenience (strength, regimen)
• Delivery system (standard tablet vs disintegrating or coated formats)
• Brand or channel strategies (OTC availability, pharmacy adoption)

How big is the market for fexofenadine and how does it map to hives specifically?

Featured-snippet answer: The fexofenadine market is sizable as an allergy antihistamine franchise, with urticaria representing a meaningful but not dominant share versus broader allergic rhinitis use. Urticaria demand tends to be driven by chronicity and payer formularies.

Market drivers for hives/urticaria treatment

• Chronic spontaneous urticaria (CSU) prevalence and long-term symptom treatment behavior
• Stepwise treatment patterns in guidelines that start with second-generation H1 antihistamines
• OTC accessibility and brand loyalty dynamics for the class
• Payer preference for lower-cost generics once exclusivity expires

Key revenue levers for fexofenadine brands

• Price premium vs generics (typically narrows quickly after first generic entries)
• Formulary placement and step edits for CSU
• Contracting and channel mix (retail vs mail order)
• Portfolio effects in allergy: cross-indication prescribing

Where hives revenue sits relative to allergic rhinitis

Most fexofenadine commercial volume is linked to allergic rhinitis. Urticaria sales are:

• More dependent on guideline adherence and physician prescribing for CSU
• More sensitive to payer restrictions once generic pressure increases

What is the exclusivity timeline for fexofenadine hydrochloride used for hives, and when does it lose exclusivity?

Featured-snippet answer: For an established active ingredient like fexofenadine hydrochloride, drug-substance exclusivity has already largely expired in most jurisdictions; current exclusivity is typically limited to specific formulation, method, or brand-label protections, which expire on a product-by-product basis.

What kinds of exclusivity can still matter for “hives” claims?

• Composition/formulation patents (specific excipient blends, coatings, or solid-state forms)
• Method-of-use patents (dosing regimens for urticaria or defined patient populations)
• Regulatory data exclusivity tied to specific approvals (jurisdiction and product specific)
• Brand-label patents in select markets

How to project loss of exclusivity for this class

A practical projection framework:

• Identify the newest, still-pending patents covering the exact dosage form and the “hives” indication in major jurisdictions.
• Map patent expiration to likely generic launch windows (considering 180-day exclusivity tied to first Paragraph IV filer in the US).
• Adjust for market behavior: even after patent expiry, price competition depends on generic manufacturing readiness and wholesaler contracting.

What patents protect fexofenadine hydrochloride for hives, and how strong is the patent estate?

Featured-snippet answer: Patent protection for fexofenadine generally concentrates on older drug-substance claims (largely expired) and smaller sets of formulation/method-of-use claims tied to specific brand products and dosage forms.

Patent estate scope: what to expect in practice

For established antihistamines:

• Many foundational chemical patents are expired.
• Remaining enforceable patents tend to cover:
  • Controlled release or specific tablet architectures
  • Novel formulations intended to improve tolerability or onset
  • Specific urticaria dosing regimens or treatment combinations

How to evaluate “strength” for licensing or litigation

• Claim scope tied to dosage form and excipients.
• Remaining life in US, EU member states, and key markets.
• Enforcement history and observed litigation posture for similar antihistamine estates.
• Ability of a generic to “design around” via alternative excipients or dosing without infringing.

Which generic entry risks exist for fexofenadine hydrochloride hives under US Orange Book and Paragraph IV?

Featured-snippet answer: If US Orange Book listing patents for a branded fexofenadine product have expired, generic entry is typically driven by formulation BE and regulatory pathway rather than Paragraph IV. Paragraph IV risk becomes relevant only where unexpired listed patents remain.

Orange Book status: what typically happens to listed patents

For mature actives:

• Listed patents related to the original brand formulation often expire.
• Remaining patents can be fewer and narrower.
• New patents may be “late-life” but still tend to face design-around.

Paragraph IV litigation dynamics (if unexpired patents exist)

• Generic filers may seek entry via Paragraph IV against listed patents.
• Litigation or settlements can shift launch timing by introducing agreed design or delayed effective dates.

What to watch for in launch scenarios

• 180-day exclusivity eligibility for the first Paragraph IV filer
• Settlement terms specifying dates and/or product design constraints
• Generic manufacturing and packaging availability
• Payer adoption speed after launch

What FDA regulatory pathway supports fexofenadine hydrochloride hives products, and what are the likely approval routes?

Featured-snippet answer: Generics and OTC switches typically use ANDA routes with bioequivalence. New formulations or strengths may use an ANDA with BE or specific supplemental NDA depending on jurisdictional strategy.

Typical regulatory pathways

• Generic approval: ANDA with demonstrated bioequivalence to a reference listed drug
• Formulation updates: ANDA supplements depending on change type
• OTC products: often governed by existing approvals and labeling rather than new mechanistic claims

Labeling considerations for urticaria

• “Urticaria” or “chronic idiopathic urticaria/CSU” language in the approved labeling drives clinical uptake.
• The key risk for generics is whether the labeling claim is tied to a patented method-of-use or a specific indication-specific regulatory listing.

How does fexofenadine hydrochloride for hives compare with other second-generation antihistamines?

Featured-snippet answer: Fexofenadine competes within the non-sedating antihistamine class, where comparative effectiveness and tolerability typically yield similar symptom control, and differentiation is driven by access, price, and patient preference.

Competitive set used in practice

• Cetirizine
• Levocetirizine
• Loratadine and desloratadine
• Rupatadine (where approved)
• Bilastine (where approved)

Decision factors that influence prescribing and switching

• Sedation profile and patient intolerance to “sleepy” agents
• Dosing frequency (once daily vs multiple daily)
• Formulary tiering and copays
• Brand vs generic contracting

What commercial projections should be used for fexofenadine hydrochloride hives through patent/market access cycles?

Featured-snippet answer: Near-term growth is constrained by genericization and class competition; the most credible upside comes from market share retention, channel expansion, and formulation-specific advantages rather than a new mechanism-driven expansion.

Projection logic for a mature active ingredient

Use a three-layer model:

1. Base demand: CSU and urticaria symptom control spend, typically stable or modestly growing with prevalence and prescribing patterns.
2. Share shifts: fexofenadine gains or loses share within second-generation antihistamines based on payer and pharmacy behavior.
3. Price erosion: generic penetration reduces revenue per unit; brand premium persists only where formulary differentiation is strong.

What drives upside in practice

• Continued OTC accessibility with strong retail distribution
• Hospital and clinic guideline usage where second-generation H1s remain first-line
• Product line extensions (new strengths or delivery formats) that preserve shelf share

What drives downside

• Faster than expected generic adoption
• Aggressive pricing by low-cost entrants
• Formulary switches toward alternative antihistamines with better reimbursement terms

What patent litigation affects fexofenadine hydrochloride hives products?

Featured-snippet answer: For mature active ingredients, the most common litigation risk is generic ANDA Paragraph IV disputes over remaining formulation or method-of-use patents tied to specific branded products. If no unexpired Orange Book patents remain for a given marketed product, litigation risk falls sharply.

Litigation watchlist

For any specific branded fexofenadine product marketed for urticaria:

• Check whether Orange Book lists any unexpired patents tied to the product’s dosage form
• Track any notice of Paragraph IV certification and resulting district court actions
• Monitor settlements for launch date carveouts and design-around parameters

Which companies compete in fexofenadine hydrochloride hives, and what matters for market share?

Featured-snippet answer: Competition is driven by generic manufacturers plus brand custodians, with market share determined by distribution, pricing, and formulary placement rather than differentiated IP.

Commercial participants

• Branded originator and brand owners (where still active)
• Multi-source generic manufacturers for tablet SKUs and strength variations
• OTC brand channel competitors for retail shelf dominance

Why the competitive landscape is structurally stable

Second-generation antihistamines have established therapeutic roles with predictable prescribing behavior. Once generics enter at scale, differentiation compresses into access economics.

Key Takeaways

• Fexofenadine hydrochloride supports urticaria symptom control based on the established clinical profile of second-generation H1 antihistamines.
• Clinical-trial activity for “hives” is typically incremental (comparative efficacy, formulation changes, bioequivalence), limiting new-mechanism differentiation.
• Market growth is constrained by generic competition; revenue outlook hinges on share retention, channel mix, and any remaining formulation or method-of-use protections tied to specific SKUs.
• US generic entry risk under Paragraph IV depends on whether unexpired Orange Book-listed patents exist for the specific branded product and dosage form covering “hives” labeling.

FAQs

1. Is fexofenadine hydrochloride effective for chronic spontaneous urticaria compared with cetirizine?
2. Do generic fexofenadine tablets preserve the same urticaria labeling and clinical endpoints as the reference product?
3. What are the most common reasons for delays in ANDA approvals for fexofenadine formulations?
4. How does OTC availability of fexofenadine affect payer-driven demand for hives indications?
5. What formulation design changes most often avoid patent claims in antihistamine formulation estates?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed 2026-05-22).
2. FDA. Drug Approval Reports / ANDA and NDA Drug Product Information. U.S. Food and Drug Administration. (Accessed 2026-05-22).
3. ClinicalTrials.gov. Search results for fexofenadine hydrochloride and urticaria/hives. U.S. National Library of Medicine. (Accessed 2026-05-22).