ADALAT CC Drug Patent Profile

When do Adalat Cc patents expire, and what generic alternatives are available?

Adalat Cc is a drug marketed by Norwich and is included in one NDA.

The generic ingredient in ADALAT CC is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adalat Cc

A generic version of ADALAT CC was approved as nifedipine by ACTAVIS ELIZABETH on January 8^th, 1991.

Summary for ADALAT CC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	29
Drug Prices:	Drug price information for ADALAT CC
What excipients (inactive ingredients) are in ADALAT CC?	ADALAT CC excipients list
DailyMed Link:	ADALAT CC at DailyMed

See drug prices for ADALAT CC

See drug sales revenues for ADALAT CC

Recent Clinical Trials for ADALAT CC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cao Yu	Phase 1
Jing Liu	Phase 4
University of Pennsylvania	Phase 4

See all ADALAT CC clinical trials

US Patents and Regulatory Information for ADALAT CC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993		DISCN	Yes	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993		DISCN	Yes	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993		DISCN	Yes	No

Expired US Patents for ADALAT CC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993	4,892,741
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993	4,892,741
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993	5,264,446
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993	5,264,446

International Patents for ADALAT CC

See the table below for patents covering ADALAT CC around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2955524
Japan	H09183728	PREPARATION OF SOLID MEDICINE
Germany	3161838
Israel	86827	PRESS COATED TABLETS CONTAINING DIHYDROPYRIDINES AND THEIR PREPARATION

Market Dynamics and Financial Trajectory of ADALAT CC

Last updated: July 28, 2025

Introduction

ADALAT CC (Nifedipine Controlled-Release) is a prescription medication primarily used to treat hypertension and angina pectoris. As a formulation of nifedipine, a calcium channel blocker, ADALAT CC benefits from its extended-release profile, offering steady plasma levels and improved patient compliance. Understanding the market dynamics and forecasting the financial trajectory for ADALAT CC involves analyzing clinical efficacy, patent landscapes, competitive environment, regulatory factors, and global healthcare trends.

Market Overview

The global antihypertensive drugs market was valued at approximately USD 28 billion in 2022 and is projected to grow at a CAGR of around 3.5% through 2030. Nifedipine formulations constitute a significant segment within this space, owing to their widespread use and established efficacy [1]. Extended-release variants like ADALAT CC meet growing demand for long-acting therapies that enhance adherence and reduce dosing frequency.

In developed markets, such as North America and Europe, ADALAT CC benefits from high penetration due to established prescribing habits, extensive cardiovascular disease (CVD) management programs, and reimbursement support. Emerging markets in Asia-Pacific, Latin America, and Africa present accelerated growth opportunities driven by increasing CVD prevalence, rising healthcare expenditure, and expanding medical infrastructure.

Key Market Drivers

1. Rising Global Burden of Hypertension

Hypertension affects over 1.2 billion people worldwide, with prevalence expected to increase due to urbanization, lifestyle changes, and aging populations. Extended-release calcium channel blockers like ADALAT CC are frontline therapies, especially for long-term patient management [2].

2. Clinical Advantages of Extended-Release Formulations

ADALAT CC’s controlled-release mechanism offers consistent drug plasma levels, reducing side effects such as hypotension and dizziness. These benefits improve patient adherence compared to immediate-release formulations, bolstering demand.

3. Favorable Regulatory Environment

Regulators generally approve formulary equivalents that demonstrate bioequivalence and safety, facilitating market entry and sustained sales for established brands like ADALAT CC. There is also a trend towards generic substitution, which impacts pricing and market penetration.

4. Patent Expiry and Generic Competition

The original patent for ADALAT CC has expired or is nearing expiration in major markets, paving the way for generic versions. Generics typically account for a significant share of sales volume, but brand loyalty and physician preference sustain demand for branded counterparts in certain segments.

5. Rising Healthcare Expenditure and Insurance Coverage

Increased healthcare spending, especially in emerging markets, coupled with expanding insurance coverage, boosts access to antihypertensive medications. This trend supports sustained growth for both branded and generic nifedipine products.

Challenges and Market Risks

1. Patent Expiration and Generic Competition

Post-patent expiry, generic manufacturers can enter the market with lower-priced formulations, intensifying price competition and diminishing profit margins for branded products like ADALAT CC.

2. Competitive Landscape

Several competitors, including other calcium channel blockers such as amlodipine and felodipine, vie for market share. The differentiation of products based on release mechanisms, dosing convenience, and price becomes critical.

3. Regulatory and Pricing Pressures

Universal reimbursement constraints and pricing negotiations tighten margins, especially in price-sensitive markets. Regulatory hurdles concerning drug approval and renewal can delay market expansion.

4. Patient Compliance and Therapy Switching

While extended-release formulations improve adherence, shifts to alternative therapies or combination drugs may influence demand for monotherapy products like ADALAT CC.

Financial Trajectory Analysis

Revenue Outlook

Forecasting revenue involves assessing current market share, generic penetration rates, and the potential for new formulations or combination therapies.

• In Mature Markets: Revenue stability is expected due to high brand loyalty and established prescribing patterns. However, revenue growth may plateau as generics saturate the market.

• In Emerging Markets: Rapidly expanding cardiovascular disease treatment programs and increasing healthcare infrastructure are likely to drive compound annual growth rates (CAGR) of 4–6%, especially with localized manufacturing and strategic partnerships.

Profitability and Investment Trends

Branded ADALAT CC historically enjoys higher margins due to brand equity and patent protections. As patent exclusivity wanes, margins are projected to decline unless the company innovates or introduces novel delivery systems.

Investment in biosimilars, combination therapies, or enhanced formulations could restore growth trajectories. Furthermore, strategic pricing and market expansion efforts in significant geographies are vital to sustaining revenue streams.

Impact of Patent and Market Entry

Patents and exclusivity rights determine the timing and scale of generic market entry. Once exclusivity lapses, the company faces heightened pricing pressures and the need to differentiate through marketing or product improvements.

Future Revenue Streams

Potential revenue sources include:

• Generic licensing agreements in markets where patents have expired.
• New formulations such as controlled-release patches or fixed-dose combinations.
• Expanding indications to broader cardiovascular and hypertensive conditions.
• Strategic acquisitions or partnerships to bolster market presence in emerging regions.

Market Opportunities and Strategic Outlook

To optimize financial outcomes, stakeholders should focus on:

• Accelerating market penetration in non-competitive territories.
• Investing in R&D for next-generation release mechanisms.
• Leveraging digital health tools for medication adherence.
• Engaging in strategic licensing and acquisition opportunities.
• Navigating regulatory pathways efficiently in emerging markets.

Key Challenges and Mitigation Strategies

• Generic Competition: Strengthen brand loyalty through physician education and patient engagement.
• Pricing Pressures: Advocate for value-based pricing models that highlight clinical benefits.
• Regulatory Changes: Maintain proactive compliance and dossier readiness.
• Market Fragmentation: Tailor marketing strategies to regional healthcare dynamics.

Conclusion

ADALAT CC's market dynamics are shaped by global hypertension trends, regulatory environments, and competitive forces. Its financial trajectory hinges on patent status, generic competition, and innovation investments. Stakeholders that rapidly adapt to evolving market conditions, focus on strategic differentiation, and expand in high-growth regions will position themselves to capitalize on the sustained demand for effective antihypertensive therapies.

Key Takeaways

• The global antihypertensive market continues to expand, driven by rising CVD prevalence and aging populations.
• ADALAT CC benefits from its controlled-release technology, favoring long-term adherence.
• Patent expirations are imminent or have occurred, intensifying competition from generics.
• Future revenue growth depends on market expansion, innovation, and strategic licensing.
• Companies must navigate regulatory landscapes and price sensitivities to maintain profitability.

FAQs

1. How does ADALAT CC differentiate itself from other nifedipine formulations?
ADALAT CC offers an extended-release profile that provides consistent plasma drug levels, reducing side effects and improving adherence compared to immediate-release formats.

2. What factors are most influencing ADALAT CC's market share post-patent expiry?
Generic competition, physician prescribing habits, price sensitivity, and patient preference are key factors impacting market share after patent expiration.

3. Are new formulations or combination therapies impacting ADALAT CC's market?
Yes, innovations such as fixed-dose combinations and alternative delivery systems are impacting the market, potentially reducing demand for traditional extended-release nifedipines.

4. Which emerging markets offer significant growth opportunities for ADALAT CC?
Countries in Asia-Pacific, Latin America, and Africa are experiencing rapid increases in hypertension prevalence and healthcare infrastructure development, making them lucrative growth targets.

5. How can pharmaceutical companies sustain profitability amid generic competition?
By investing in product differentiation, expanding into new indications, developing new formulations, engaging in market-specific marketing, and implementing value-based pricing strategies.

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Sources

[1] Market Research Future. (2022). Global Antihypertensive Drugs Market Analysis.
[2] World Health Organization. (2021). Hypertension: Key facts and statistics.