CLINICAL TRIALS PROFILE FOR FAMOTIDINE

505(b)(2) Clinical Trials for FAMOTIDINE

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	NCT03145012 ↗	Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity	Unknown status	Dalhousie University	Phase 4	2018-05-01	The immune response against tumors can be highly effective in preventing tumor development, growth and metastasis under certain circumstances. However, tumor associated immune suppression can profoundly limit the impact of natural tumor immunity and also reduce the effectiveness of tumor immunotherapy strategies. A major component of tumor associated immune suppression is mediated by myeloid cells, especially the monocytic subset of myeloid derived suppressor cells (MDSC). In recent studies that were conducted through a CCSRI Innovation grant, the investigators discovered that oral treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or famotidine inhibits both primary breast tumor development and metastasis, in three distinct mouse tumor models and reduces the numbers of monocytic MDSC. These findings have enormous potential to aid in effective cancer immunotherapy and may have immediate implications for cancer patients. The objective of this investigation is to determine whether treatment with the H2 receptor antagonist ranitidine alters immune suppression, through modulation of immune cell populations. The investigators will examine peripheral blood monocyte, neutrophil and NK cell numbers, subsets and activation status from healthy volunteers treated for 6 weeks with daily oral ranitidine. Ranitidine is widely available and used over the counter in Canada. These drugs are widely recognized as safe, well tolerated and have very few side effects. It has been suggested that among the general population, over 10% of those over the age of 65 take such medications on a regular basis for relief against gastrointestinal discomfort. The outcome of pre-clinical studies in mice warrant further investigation into transferability to humans. If the outcome of the current proposal proves to be viable, then these drugs could provide a safe method to reduce tumor associated immunosuppression with broad implications, both for current cancer patients and for those at high risk of developing cancer. Further to this, the outcome of our proposal may provide a new strategy for improving the effectiveness of T-cell mediated immunotherapy.
OTC	NCT03145012 ↗	Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity	Unknown status	Nova Scotia Health Authority	Phase 4	2018-05-01	The immune response against tumors can be highly effective in preventing tumor development, growth and metastasis under certain circumstances. However, tumor associated immune suppression can profoundly limit the impact of natural tumor immunity and also reduce the effectiveness of tumor immunotherapy strategies. A major component of tumor associated immune suppression is mediated by myeloid cells, especially the monocytic subset of myeloid derived suppressor cells (MDSC). In recent studies that were conducted through a CCSRI Innovation grant, the investigators discovered that oral treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or famotidine inhibits both primary breast tumor development and metastasis, in three distinct mouse tumor models and reduces the numbers of monocytic MDSC. These findings have enormous potential to aid in effective cancer immunotherapy and may have immediate implications for cancer patients. The objective of this investigation is to determine whether treatment with the H2 receptor antagonist ranitidine alters immune suppression, through modulation of immune cell populations. The investigators will examine peripheral blood monocyte, neutrophil and NK cell numbers, subsets and activation status from healthy volunteers treated for 6 weeks with daily oral ranitidine. Ranitidine is widely available and used over the counter in Canada. These drugs are widely recognized as safe, well tolerated and have very few side effects. It has been suggested that among the general population, over 10% of those over the age of 65 take such medications on a regular basis for relief against gastrointestinal discomfort. The outcome of pre-clinical studies in mice warrant further investigation into transferability to humans. If the outcome of the current proposal proves to be viable, then these drugs could provide a safe method to reduce tumor associated immunosuppression with broad implications, both for current cancer patients and for those at high risk of developing cancer. Further to this, the outcome of our proposal may provide a new strategy for improving the effectiveness of T-cell mediated immunotherapy.
OTC	NCT03145012 ↗	Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity	Unknown status	Lisa Barrett	Phase 4	2018-05-01	The immune response against tumors can be highly effective in preventing tumor development, growth and metastasis under certain circumstances. However, tumor associated immune suppression can profoundly limit the impact of natural tumor immunity and also reduce the effectiveness of tumor immunotherapy strategies. A major component of tumor associated immune suppression is mediated by myeloid cells, especially the monocytic subset of myeloid derived suppressor cells (MDSC). In recent studies that were conducted through a CCSRI Innovation grant, the investigators discovered that oral treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or famotidine inhibits both primary breast tumor development and metastasis, in three distinct mouse tumor models and reduces the numbers of monocytic MDSC. These findings have enormous potential to aid in effective cancer immunotherapy and may have immediate implications for cancer patients. The objective of this investigation is to determine whether treatment with the H2 receptor antagonist ranitidine alters immune suppression, through modulation of immune cell populations. The investigators will examine peripheral blood monocyte, neutrophil and NK cell numbers, subsets and activation status from healthy volunteers treated for 6 weeks with daily oral ranitidine. Ranitidine is widely available and used over the counter in Canada. These drugs are widely recognized as safe, well tolerated and have very few side effects. It has been suggested that among the general population, over 10% of those over the age of 65 take such medications on a regular basis for relief against gastrointestinal discomfort. The outcome of pre-clinical studies in mice warrant further investigation into transferability to humans. If the outcome of the current proposal proves to be viable, then these drugs could provide a safe method to reduce tumor associated immunosuppression with broad implications, both for current cancer patients and for those at high risk of developing cancer. Further to this, the outcome of our proposal may provide a new strategy for improving the effectiveness of T-cell mediated immunotherapy.

All Clinical Trials for FAMOTIDINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00141960 ↗	Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease	Completed	Astellas Pharma Inc	Phase 2/Phase 3	2005-09-01	Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.
NCT00153673 ↗	Effect of Selective COX-2 Inhibition on Ulcer Healing	Completed	Chinese University of Hong Kong	Phase 3	2001-02-01	The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.
NCT00229424 ↗	Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -	Completed	UCB Pharma	Phase 3	2005-04-01	The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.
NCT00229424 ↗	Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -	Completed	Taiho Pharmaceutical Co., Ltd.	Phase 3	2005-04-01	The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.
NCT00365339 ↗	Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir	Completed	Bristol-Myers Squibb	Phase 1	2006-04-01	The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.
NCT00384904 ↗	Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 4	2006-12-01	The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.

Clinical Trial Conditions for FAMOTIDINE

Condition Name

Condition Name for FAMOTIDINE
Intervention	Trials
Healthy Participants	12
Healthy	10
Covid19	8
Covid-19	7

Condition MeSH

Condition MeSH for FAMOTIDINE
Intervention	Trials
COVID-19	12
Ulcer	10
Gastroesophageal Reflux	7
Peptic Ulcer	7

Clinical Trial Locations for FAMOTIDINE

Trials by Country

Trials by Country for FAMOTIDINE
Location	Trials
United States	108
China	18
Taiwan	9
Canada	8
Korea, Republic of	8

Trials by US State

Trials by US State for FAMOTIDINE
Location	Trials
Texas	25
California	9
New York	7
Florida	7
Pennsylvania	7

Clinical Trial Progress for FAMOTIDINE

Clinical Trial Phase

Clinical Trial Phase for FAMOTIDINE
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	5

Clinical Trial Status

Clinical Trial Status for FAMOTIDINE
Clinical Trial Phase	Trials
Completed	73
RECRUITING	23
Not yet recruiting	12

Clinical Trial Sponsors for FAMOTIDINE

Sponsor Name

Sponsor Name for FAMOTIDINE
Sponsor	Trials
Bristol-Myers Squibb	18
M.D. Anderson Cancer Center	8
Horizon Pharma Ireland, Ltd., Dublin Ireland	5

Sponsor Type

Sponsor Type for FAMOTIDINE
Sponsor	Trials
Other	104
Industry	75
NIH	5

Last updated: June 6, 2026

Famotidine clinical trials update, market analysis, and projection: exclusivity, competition, and FDA pathway outlook

Famotidine is a widely genericized, off-patent histamine H2-receptor antagonist used for gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD), and dyspepsia. Clinical development is not patent-timed in the way it is for newer branded products; most new activity targets formulation, route changes, pediatric labeling, and incremental safety or dosing. Commercial upside is driven by (1) uptake of specific formulations, (2) competitive intensity from generics, and (3) supply-side stability for key manufacturing and API inputs.

What is the current status of famotidine clinical trials?

No complete, verifiable, up-to-date registry snapshot is available in the provided context. Without a specific trial list (NCT identifiers, phase, sites, endpoints, enrollment status, and dates), an accurate clinical-trials update cannot be produced.

Which famotidine indications are typically being studied

Famotidine’s most common modern development themes include:

• GERD and non-erosive reflux disease efficacy with alternative dosing regimens
• Peptic ulcer prophylaxis and treatment, including ulcer-related hospitalization endpoints
• Pediatric symptom control and label expansions
• Formulation work for faster onset, reduced pill burden, or altered release kinetics
• Alternative delivery routes aimed at hospital workflow (oral vs parenteral differentiation)

What phase distribution usually looks like in famotidine

For off-patent actives, development activity commonly shifts to:

• Phase 1/2 bridging studies for pharmacokinetics (bioequivalence or comparative PK/PD)
• Small Phase 3 comparative symptom trials when seeking label changes for specific populations
• Human factors and stability work for new dosage forms

How big is the famotidine market today and what are the revenue drivers?

A complete market analysis with quantified revenue levels, segment shares, and channel breakdown requires a specific data source set (e.g., IQVIA, GlobalData, company reports). No market figures are provided in the prompt context, so a numeric market assessment cannot be generated.

Key revenue drivers that matter commercially

Even without a quantified market number, the drivers are stable:

• Generic volume share: famotidine is a low-price, high-volume commodity drug
• Formulation differentiation: oral tablets/suspensions dominate retail; injectable demand is more captive to hospital formularies
• Competitive pricing: frequent generic entrants compress margins
• Supply continuity: API and manufacturing outages can swing local availability and pricing
• Policy and labeling: changes that expand pediatric or ulcer indications can create marginal uptake

Pricing pressure and margin reality

For widely genericized H2 blockers, revenue growth typically comes from units, not price. ASP and gross margin are usually determined by:

• number of approved ANDA products
• competitive intensity at key pharmacy chains and GPOs
• formulary wins in institutional settings

When does famotidine lose exclusivity and how does that affect new entrants?

Famotidine is not tied to a single, near-term branded exclusivity event in the way newer drugs are. In practice, market access is constrained by:

• FDA-accepted ANDA/505(b)(2) pathways for specific dosage forms
• patent tail risk for any remaining formulation, method-of-use, or process patents held by specific applicants for specific products
• pediatric exclusivity only if a specific sponsor obtained it for a specific labeled change

Because no specific branded reference product, dosage form, or Orange Book entry list is provided, a precise “loss of exclusivity date” timeline cannot be stated.

What patents protect famotidine and how many patent estates exist?

A complete patent landscape requires an Orange Book and patent-registry pull for:

• the specific listed reference products in the FDA Orange Book
• related US patents (composition, method of use, formulation, and manufacturing processes)
• continuation family scope and expiration dates by claim set

No such dataset is available in the prompt context. A precise “how many patents” and “which estates” count cannot be generated without producing incomplete or potentially incorrect legal mappings.

What typically appears in H2 blocker patent estates

Where remaining patents exist in this category, they tend to be:

• controlled-release or fixed-dose combination formulations
• pediatric dosing regimens
• manufacturing processes that improve stability, dissolution, or bioavailability

What is the Orange Book status of famotidine tablets, suspension, and injection?

Orange Book status must be built from the FDA database listings for:

• each strength and dosage form
• each reference listed drug (RLD) name
• listed patents and their expiration dates
• exclusivity codes

No RLD/Orange Book entry information is provided, so the Orange Book status cannot be accurately reported.

What generic entry risks exist for famotidine?

For an off-patent active, “entry risk” usually reduces to:

• whether any product-specific patents still block certain strengths or dosage forms
• whether Paragraph IV certification is required to address listed patents
• whether the relevant listed patents are “carve-out” safe or trigger litigation

Without Orange Book-listed patents and a catalog of ANDA filings, the entry-risk profile cannot be stated with actionable specificity.

Which companies are challenging famotidine and what litigation patterns exist?

A litigation update requires:

• case captions and docketed filings (e.g., Paragraph IV suits)
• brands/RLD and asserted patents
• settlement terms and trigger dates

No litigation dataset is provided, so a credible “which companies are challenging” section cannot be written without inventing facts.

How do famotidine clinical and regulatory updates compare with cimetidine and other H2 blockers?

A comparative analysis requires market and regulatory context:

• indication approvals
• label differences (adult vs pediatric, reflux vs ulcer)
• formulation differentiation and tolerability endpoints
• competitive availability and pricing

No comparative source details are included in the prompt context, so a data-driven comparison cannot be produced.

What FDA pathways are relevant for famotidine new formulations?

For an off-patent active, common pathways include:

• ANDA for generic tablets/suspensions
• 505(b)(2) for reformulations that require bridging to published data or for certain delivery changes
• sNDA for specific label expansions if sponsor-funded studies support clinical endpoints

A pathway-by-pathway mapping for “famotidine clinical trial update and market projection” requires current FDA approvals and application histories, which are not provided here.

How strong is the patent estate for famotidine in US and key international markets?

Patent strength is determined by:

• remaining patent term (by claim and jurisdiction)
• enforceability (litigation history, claim scope, obviousness risk)
• product coverage (which dosage forms and strengths are within claim scope)

No jurisdictional patent list is supplied, so a strength assessment cannot be delivered.

Market projection for famotidine through the next 3 to 5 years

A projection must quantify:

• unit growth assumptions
• price erosion assumptions
• entry timing by generic suppliers
• substitution between H2 blockers and competing GERD classes (PPI, PCAB)
• government and payer formulary impacts

The prompt includes no market forecast figures or assumptions set, and no input sources are present. A numerical projection would be speculative.

Qualitative projection drivers that typically govern famotidine

• Ongoing generic competition keeps price growth near zero and tracks inflation only
• Unit growth depends on disease prevalence trends and competitive switching patterns
• Hospital use of injectable formulations can fluctuate with supply and formulary preference
• Any reformulation that improves adherence or administration can protect unit share in narrow segments

Key takeaways

• Famotidine is largely off-patent and competitively generic; clinical development is more likely formulation- and label-adjacent than truly novel.
• A credible, quantified clinical-trials update, Orange Book/patent mapping, and market forecast require specific registry and database inputs that are not included in the prompt context.
• Commercial outcomes are primarily driven by generic supply, pricing, formulary uptake by dosage form, and incremental product differentiation rather than exclusivity.

FAQs

1) Are there any ongoing Phase 3 famotidine trials in GERD?
No verified Phase 3 trial list is available in the provided context.

2) Does famotidine have pediatric exclusivity for any dosage form?
No exclusivity details are provided here.

3) What dosage forms of famotidine tend to see the most reformulation activity?
Oral tablets and suspensions most commonly receive bioequivalence and dissolution/stability work; injectables also see change-driven submissions.

4) How do proton pump inhibitors affect famotidine demand?
Higher PPI penetration typically pressures H2 blocker share in GERD, shifting famotidine toward niches and step-down regimens.

5) What is the typical timeline for generic approvals after ANDA submission for low-cost actives like famotidine?
Approval timing depends on review capacity and chemistry controls and cannot be stated accurately without a specific ANDA dataset.

References

No sources were provided or cited in the prompt context.