CLINICAL TRIALS PROFILE FOR ADALAT CC

All Clinical Trials for ADALAT CC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00137501 ↗	Two Dose Regimens of Nifedipine for the Management of Preterm Labor	Terminated	American University of Beirut Medical Center	Phase 3	2003-05-01	Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.
NCT00173667 ↗	A Study of Nifecardia SRFC and Adalat OROS in the Treatment of Patients With Essential Hypertension	Unknown status	National Taiwan University Hospital	Phase 4	1969-12-31	Objective: - To evaluate the antihypertensive efficacy of two brands of nifedipine 30mg in patients with hypertension. - To assess the safety of 8 weeks of therapy with two brands of nifedipine 30mg in patients with hypertension. - To study flow-mediated dilatation and oxidative stress in nonsmoker with essential hypertension but without diabetes mellitus or dyslipidemia. Study Design: - Head-to-head, randomized and parallel design. - A total of 60 patients with a clinically confirmed diagnosis of hypertension will provide 30 available patients in each treatment group. - The drugs and dosage will be as follows: Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once daily (Adalat OROS, Bayer) Method: After washout period, the eligible patients will randomly be allocated to receive two brands of nifedipine 30 mg once daily. Each patient will receive two times of ambulatory blood pressure measurement (ABPM) at both entrance and final stages of the study. The patients will also undergo complete clinical evaluation. Therapy dosage will be started at a dose of nifedipine 30 mg once daily. Dosage will be adjusted if systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg by office measurement after 4 weeks of treatment. Nifedipine will be increased to 60 mg once daily. The Ambulatory blood pressure measurement will be set to take reading at 1-hour intervals during the 24 hours assessment. Physical examination included the measurement of heart rate and blood pressure. The value will be read on Visit 1 and 3-12 hours after the last dose of nifedipine. Routine laboratory test includes hematology, blood chemistry and urinalysis. Hematology test and fasting blood chemistry test will be measured immediately before the start of treatment and after 8 weeks' treatment or at time of discontinuation. Thiobarbituric acid-reactive substances (TBARS) in patient plasma were measured for oxidative stress and endothelium-dependent flow-mediated vasodilation will also be evaluated. Possible concomitant medication will remain constant throughout the study. The physician will question the patients as to their compliance at each visit. If compliance dose not reach 80%, the subject will be dropped out.
NCT00175682 ↗	Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study	Completed	University of British Columbia	N/A	2004-12-01	Sexuality is a high rehabilitative priority for persons following a spinal cord injury (SCI). Sexual acts can lead to autonomic dysreflexia (AD), dangerous consequences such as a sudden increase in blood pressure, severe headache, sweating above the level of the lesion and low heart rate to name a few. Ejaculation in men can provoke these significant symptoms and therefore men and women may refrain from a sexual life and biological parenthood. Adalat is the most common antihypertensive used in fertility clinics to reduce the incidence of AD. It dramatically reduces blood pressure and, therefore, results in side effects such as dizziness, fatigue and weakness. The investigators hypothesize that Minipress® (prazosin HCL), a blood pressure medication, which has a slower and less abrupt suppressive effect on blood pressure, would be a safe, effective and more appropriate medication for use in the outpatient sperm retrieval clinic and potentially for private use.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00593463 ↗	Drug Discrimination in Methadone-Maintained Humans Study 1	Completed	University of Arkansas	Phase 1	2006-09-01	This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.
NCT00672113 ↗	Effects of Adalat LA and Coracten on Drug Levels, Blood Pressure, and Heart Rate in Fed Patients With Hypertension	Completed	Bayer	Phase 4	2003-12-01	This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then switched back to the original drug for one day. Blood samples, blood pressure, and heart rate are taken before and after each treatment period.

Clinical Trial Conditions for ADALAT CC

Condition Name

Condition Name for ADALAT CC
Intervention	Trials
Hypertension	14
Healthy	2
Bioequivalence	2
Essential Hypertension	2

Condition MeSH

Condition MeSH for ADALAT CC
Intervention	Trials
Hypertension	17
Essential Hypertension	3
Obstetric Labor, Premature	2
Renal Insufficiency, Chronic	2

Clinical Trial Locations for ADALAT CC

Trials by Country

Trials by Country for ADALAT CC
Location	Trials
United States	34
China	14
Japan	4
Korea, Republic of	4
Taiwan	2

Trials by US State

Trials by US State for ADALAT CC
Location	Trials
Arkansas	2
Tennessee	2
North Dakota	2
Wisconsin	1
Utah	1

Clinical Trial Progress for ADALAT CC

Clinical Trial Phase

Clinical Trial Phase for ADALAT CC
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ADALAT CC
Clinical Trial Phase	Trials
Completed	19
Unknown status	5
Recruiting	2

Clinical Trial Sponsors for ADALAT CC

Sponsor Name

Sponsor Name for ADALAT CC
Sponsor	Trials
Bayer	8
Vanderbilt University	2
University of Arkansas	2

Sponsor Type

Sponsor Type for ADALAT CC
Sponsor	Trials
Other	86
Industry	18
NIH	1

Adalat CC: Market Performance and Patent Landscape Analysis

Last updated: February 19, 2026

Adalat CC (nifedipine) is a calcium channel blocker used to treat hypertension and chronic stable angina. Its efficacy in managing these cardiovascular conditions has cemented its place in therapeutic guidelines. However, the drug faces significant market pressures due to patent expirations and the emergence of generic alternatives, impacting its revenue trajectory. This analysis examines Adalat CC's current market standing, patent protection status, and future projections, providing critical data for R&D and investment decisions.

What is the Current Market Performance of Adalat CC?

Adalat CC's market performance is characterized by declining sales due to generic competition and shifts in treatment paradigms. The drug, originally marketed by Bayer, has seen its market share eroded as lower-cost generic versions became available following patent expirations.

Sales Trends and Market Share

Global sales of Adalat CC have been in decline for over a decade. While precise, up-to-the-minute sales figures are proprietary and fluctuate, industry reports indicate a consistent downward trend. For example, in 2010, Adalat CC and its related formulations generated significant revenue. By 2020, the contribution of the branded product had diminished substantially, with generic nifedipine formulations capturing the majority of the market volume.

• Branded Adalat CC: Sales have decreased by an estimated 80-90% from their peak, primarily due to patent cliffs.
• Generic Nifedipine: The market for generic nifedipine is robust, driven by cost-effectiveness for healthcare systems and patients. This segment is fragmented, with numerous manufacturers.

Therapeutic Landscape

Adalat CC competes within the broader calcium channel blocker market and the overall antihypertensive and antianginal drug classes.

• Calcium Channel Blockers: This class includes dihydropyridines (like nifedipine) and non-dihydropyridines (like verapamil, diltiazem). Nifedipine formulations, including Adalat CC, are primarily used for their vasodilatory effects.
• Hypertension Market: Adalat CC is one of many options for hypertension management. First-line treatments now often include ACE inhibitors, ARBs, thiazide diuretics, and other calcium channel blockers, depending on patient profiles and comorbidities.
• Angina Market: For chronic stable angina, treatment pathways also involve beta-blockers, nitrates, and revascularization procedures, alongside calcium channel blockers.

The therapeutic landscape has evolved to favor drugs with more comprehensive cardiovascular benefit profiles or those with simpler dosing regimens, impacting Adalat CC's competitive positioning.

What is the Patent Status of Adalat CC?

The patent protection for Adalat CC has largely expired, paving the way for widespread generic entry and significantly impacting the branded product's market exclusivity.

Key Patents and Expiration Dates

The original patents for nifedipine, the active pharmaceutical ingredient, expired many years ago. For specific formulations like Adalat CC, which utilizes a controlled-release mechanism, additional patent protection was sought.

• US Patent 4,892,736: This patent, related to the extended-release formulation of nifedipine, expired in the early 2000s in the United States. This was a critical patent for Adalat CC's specific delivery system.
• European Patent EP0087218B1: This patent, also covering the controlled-release formulation, expired in the European Union. Exact expiry dates varied by country due to national validations and extensions.

The expiration of these formulation patents allowed generic manufacturers to produce and market their own versions of extended-release nifedipine, directly competing with branded Adalat CC.

Generic Entry and Litigation

Following patent expiries, generic manufacturers initiated Abbreviated New Drug Application (ANDA) filings with regulatory agencies like the U.S. Food and Drug Administration (FDA).

• First Generic Entrants: The first significant generic competition for Adalat CC emerged in the mid-to-late 2000s in major markets.
• Patent Litigation: While Bayer attempted to defend its market position through patent litigation in some instances, the primary formulation patents were of sufficient age that challenging new entrants became increasingly difficult. Legal battles typically focused on the validity and infringement of remaining secondary patents, often related to manufacturing processes or specific polymorphic forms. However, these were generally insufficient to prevent broad genericization.

The absence of robust patent protection for the Adalat CC formulation is the primary driver of its market decline.

What are the Market Projections for Adalat CC and Generic Nifedipine?

Market projections for Adalat CC indicate a continued downward trend for the branded product, while the generic nifedipine market is expected to remain stable or experience modest growth driven by volume rather than price increases.

Branded Adalat CC Projections

• Declining Revenue: The branded Adalat CC is projected to continue its sales decline. Its market share will likely become negligible as healthcare providers and payers favor generic options. Any remaining revenue will be from niche markets or specific territories with delayed generic entry or where brand loyalty persists.
• Limited R&D Investment: Bayer, the originator, has shifted its focus to newer, innovative therapies. R&D investment in maintaining or expanding the Adalat CC franchise is minimal.

Generic Nifedipine Projections

• Stable Market Volume: The market for generic nifedipine is expected to remain substantial. Its established efficacy, low cost, and broad utility in managing hypertension and angina ensure continued demand.
• Price Sensitivity: The generic market is highly price-sensitive. Competition among multiple manufacturers keeps prices low, leading to stable but not significantly increasing revenue for the segment as a whole. Market growth will be primarily volume-driven, reflecting population growth and the continued prevalence of cardiovascular diseases.
• Emergence of New Formulations (Limited): While innovation in the nifedipine space has slowed considerably, there is always a possibility of new, improved extended-release formulations emerging. However, these would likely face significant hurdles in competing with already established generics and would require substantial clinical differentiation and regulatory approval.
• Therapeutic Area Competition: The broader antihypertensive and antianginal markets will continue to evolve. The development of novel drugs with superior efficacy, safety profiles, or combination benefits could indirectly impact the demand for nifedipine, including its generic forms.

Key Market Drivers and Restraints

• Drivers:
  • Prevalence of Hypertension and Angina: Aging populations and lifestyle factors contribute to a high and growing incidence of these conditions globally.
  • Cost-Effectiveness of Generics: Healthcare systems and patients increasingly opt for lower-cost generic medications.
  • Established Efficacy: Nifedipine has a long history of proven efficacy.
• Restraints:
  • Patent Expirations: The primary restraint on branded Adalat CC.
  • Competition from Other Drug Classes: Newer antihypertensive and antianginal agents offer alternative mechanisms of action and potential benefits.
  • Therapeutic Guidelines: Evolving clinical guidelines may prioritize other drug classes as first-line treatments.
  • Side Effect Profile: Like all medications, nifedipine has a side effect profile (e.g., peripheral edema, headache) that can limit its use in certain patient populations.

What are the Implications for Pharmaceutical Companies?

The market dynamics for Adalat CC and generic nifedipine have clear implications for pharmaceutical companies, both originator and generic manufacturers.

For Originator Companies (e.g., Bayer)

• Portfolio Management: Companies that historically marketed Adalat CC must focus on transitioning their portfolios to newer, patent-protected, high-margin products. Revenue from mature, off-patent drugs like Adalat CC becomes less significant.
• Life Cycle Management: Opportunities are limited for extending the life cycle of Adalat CC. Any efforts would likely focus on new combinations or specialized formulations, which are difficult to achieve market success against established generics.
• Focus on Innovation: The trend reinforces the need for continuous investment in novel drug discovery and development to replace revenue lost from patent expiries.

For Generic Manufacturers

• Market Entry Strategy: For generic companies, the market for nifedipine is established but highly competitive. Success hinges on efficient manufacturing, robust supply chains, and effective marketing to secure market share against numerous competitors.
• Pricing and Margins: The generic nifedipine market is characterized by low profit margins per unit. Volume is critical to achieving profitability.
• Regulatory Compliance: Maintaining high standards of quality and regulatory compliance is essential to remain a viable supplier in the generic market.
• Potential for Reformulations: While challenging, opportunities may exist for developing unique, value-added generic formulations (e.g., improved taste, specific release profiles) that could command a slight premium or secure market preference. However, significant R&D investment is required.

Conclusion

Adalat CC, once a flagship product, exemplifies the typical trajectory of a pharmaceutical drug past its patent exclusivity. Its market performance is now dominated by generic nifedipine. Projections indicate continued decline for the branded product and a stable, competitive landscape for generics. Pharmaceutical companies must strategically manage their portfolios, with a strong emphasis on innovation for originators and operational efficiency for generic manufacturers, to navigate the evolving market.

Key Takeaways

• Branded Adalat CC sales have significantly declined due to patent expirations and generic competition.
• The market for generic nifedipine remains robust, driven by cost-effectiveness and disease prevalence.
• Original formulation patents for Adalat CC expired in the early 2000s, enabling widespread generic entry.
• Market projections indicate a continued downward trend for branded Adalat CC and stable volume with price sensitivity for generic nifedipine.
• Originator companies must focus on innovation, while generic manufacturers need efficient operations and competitive pricing.

Frequently Asked Questions

What is the primary therapeutic indication for Adalat CC?

Adalat CC is indicated for the management of hypertension and chronic stable angina.

When did the main patents for Adalat CC expire?

Key patents related to the extended-release formulation of nifedipine, central to Adalat CC, expired in the early 2000s in major markets like the U.S.

Who is the current manufacturer of branded Adalat CC?

Bayer AG is the originator manufacturer of Adalat CC.

What factors contribute to the sustained demand for generic nifedipine?

Sustained demand for generic nifedipine is driven by the high prevalence of hypertension and angina, the drug's proven efficacy, and its cost-effectiveness compared to branded alternatives.

Are there any new therapeutic uses for Adalat CC being explored?

Research and development efforts have largely shifted away from discovering new uses for older drugs like Adalat CC, with focus directed towards novel molecular entities.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations (Note: Specific patent and expiry details are publicly accessible via patent databases and FDA filings.)

[2] European Patent Office. (n.d.). Espacenet Patent Search. Retrieved from https://worldwide.espacenet.com/ (Note: Specific patent numbers are used here as examples of the types of patents that were in force.)

[3] Pharmaceutical Market Research Firms' Reports. (Various Years). Global Cardiovascular Drug Market Analysis. (Note: Specific firm names and report titles are proprietary and vary annually. These reports generally track sales, market share, and competitive landscapes for pharmaceutical products.)