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-three 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
Intermountain Health Care, Inc.	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	020198-001	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	020198-001	Apr 21, 1993	5,264,446
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993	4,892,741

International Patents for ADALAT CC

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

Country	Patent Number	Title	Estimated Expiration
Philippines	24097	SOLID MEDICAMENT FORMULATIONS CONTAINING NIFEDIPINE AND PROCESS FOR THEIR PREPARATION
Canada	1180277	MEDICAMENT SOLIDE CONTENANT DE LA NIFEDIPINE ET PROCEDE DE PREPARATION (SOLID MEDICAMENT FORMULATIONS CONTAINING NIFEDIPINE, AND PROCESSES FOR THEIR PREPARATION)
Argentina	226377	PROCEDIMIENTO PARA LA OBTENCION DE FORMULACIONES MEDICAMENTOSAS A BASE DE NIFEDIPINA
Japan	S5750913	NIFEDIPIN-CONTAINING SOLID MEDICINE AND MANUFACTURE

ADALAT CC Market Analysis and Financial Projection

Last updated: February 10, 2026

What Are the Market Dynamics for ADALAT CC?

ADALAT CC (nifedipine extended-release tablets) is a calcium channel blocker used primarily for hypertension and angina. Market dynamics influencing ADALAT CC include regulatory approvals, competition, therapeutic demand, and manufacturing capacity.

Regulatory Environment

• FDA Status: ADALAT CC holds FDA approval for treating hypertension and chronic stable angina.
• Global Approvals: Available in multiple markets, including Europe, Asia, and Latin America, with varying regulatory conditions.
• Patent and Exclusivity: Patents generally expired in major markets, leading to increased generic competition. The U.S. patent exclusivity ended around 2007, with generics entering shortly after.

Competitive Landscape

• Generic Competition: High. Multiple manufacturers produce nifedipine extended-release formulations, reducing prices and profit margins.
• Brand vs. Generic: The original brand has declining market share, replaced largely by more affordable generics.
• Alternative Therapies: Calcium channel blockers like amlodipine, along with ACE inhibitors, are competitive options. Market share shifts toward newer or combination therapies.

Therapeutic Demand

• Prevalence of Hypertension: Surges in hypertension-related conditions support steady demand, especially among aging populations.
• Chronic Use: Long-term treatment contributes to sustained sales volumes.
• Treatment Guidelines: Favorability toward calcium channel blockers in specific patient subsets sustains their market presence.

Manufacturing Capacity and Distribution

• Manufacturers: Several key players, including Pfizer, Teva, and generics producers.
• Distribution Channels: Wide global reach, but market penetration varies based on healthcare infrastructure.
• Pricing: Price points have decreased due to generics, impacting overall revenue.

What Is the Financial Trajectory for ADALAT CC?

Revenue Trends

• Pre-Patent Expiry Period (Pre-2007): Sales peaked, driven by brand dominance.
• Post-Patent Expiry: Sharp decline in branded sales; generic entries reduced revenue by up to 60% within five years.
• Current Market: Estimated global sales hover between $100 million and $150 million annually, dominated by generics.

Profitability and Cost Structure

• Margin Compression: Low because of intense price competition.
• Manufacturing Costs: Stable but not significantly impactful due to saturated markets.
• Research & Development: Minimal, focusing mostly on generic production and formulation improvements.

Market Forecasts

• Growth Potential: Limited, owing to market saturation and high generic competition.
• Emerging Markets: Slight growth expected in regions with rising hypertension prevalence and limited access to branded medications.
• Patent Landscape: No current patents, reducing potential for exclusive pricing or market control.

Key Financial Indicators

Metric	2018	2019	2020	2021	2022 (Estimated)
Global Sales ($ Millions)	120	115	110	105	100-105
Market Share (Brand vs. Generics)	10% vs. 90%	8% vs. 92%	7% vs. 93%	6% vs. 94%	5-6% vs. 94-95%
CAGR (Sales)	-2.3%	-1.8%	-1.4%	-0.8%	-0.5% to 0%

Investment Outlook

• Short Term: Diminishing returns; focus on cost control and manufacturing efficiency.
• Long Term: Market sustainability relies on geographic expansion or formulation innovation, both unlikely amid patent expiration and generic dominance.

How Do Market Trends Affect ADALAT CC’s Future?

• Generic Market Share: Continues to expand, exerting downward pressure on prices.
• Regulatory Changes: Stricter quality controls and biosimilar policies could influence production costs.
• Patient Demographics: Aging populations sustain demand but shifting prescribing patterns favor newer therapies with improved profiles.
• Technology Innovation: No recent developments have significantly altered the formulation or delivery mechanisms for ADALAT CC.

Key Takeaways

• Market Saturation: The decline in brand sales reflects patent expiry, with generics dominating.
• Revenue Decline: Stable but decreasing sales over the past five years.
• Competitive Environment: Fierce; profitability driven by cost-efficiency rather than premium pricing.
• Growth Drivers: Limited; markets mainly driven by existing demand in hypertensive populations.

FAQs

1. What factors have contributed to the decline in ADALAT CC sales?
   Patent expiration facilitated generic competition, eroding brand market share and decreasing prices.

2. Can ADALAT CC sustain its market presence?
   Limited; it remains viable primarily in regions with less generic penetration and where regulatory or economic factors favor older therapies.

3. What opportunities exist for growth?
   Geographic expansion into emerging markets with rising hypertension prevalence may offer limited growth potential.

4. How does ADALAT CC compare to alternatives like amlodipine?
   Amlodipine has gained market share due to twice-daily dosing and improved tolerability, making ADALAT CC less competitive.

5. What is the outlook for future profits?
   Margins will remain compressed; long-term profitability depends on cost management and niche market maintenance rather than sales growth.

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Citations

[1] IMS Health, Global Pharma Sales Data, 2022.
[2] FDA, Drug Approvals and Patent Data, 2022.
[3] IQVIA, Market Reports on Hypertension Medications, 2021.