Nifedipine - Generic Drug Details

What are the generic sources for nifedipine and what is the scope of freedom to operate?

Nifedipine is the generic ingredient in six branded drugs marketed by Bayer Pharms, Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Teva, Velzen Pharma Pvt, Pfizer, Norwich, Watson Labs, Watson Labs Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Endo Operations, Martec Usa Llc, Norvium Bioscience, Novast Labs, Osmotica Pharm Us, Rising, Spil, Swiss Pharm, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for nifedipine. Thirty-six suppliers are listed for this compound.

Summary for nifedipine

US Patents:	0
Tradenames:	6
Applicants:	27
NDAs:	36
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	165
Patent Applications:	7,031
Drug Prices:	Drug price trends for nifedipine
Drug Sales Revenues:	Drug sales revenues for nifedipine
What excipients (inactive ingredients) are in nifedipine?	nifedipine excipients list
DailyMed Link:	nifedipine at DailyMed

See drug prices for nifedipine

See drug sales revenues for nifedipine

Recent Clinical Trials for nifedipine

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

Sponsor	Phase
Marshall University	Phase 2
Queen Mary University of London	N/A
Medical College of Wisconsin	Phase 3

See all nifedipine clinical trials

Pharmacology for nifedipine

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for nifedipine

Calcium Channel Blockers

Tocolytic Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for nifedipine

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

US Patents and Regulatory Information for nifedipine

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
Zydus Pharms	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	210184-003	Jun 29, 2018	AB1	RX	No	No
Valeant Pharms North	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	076070-001	Aug 16, 2002	AB1	RX	No	No
Zydus Pharms	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	210184-002	Jun 29, 2018	AB1	RX	No	No
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-002	Jul 24, 1986		DISCN	Yes	No
Actavis Elizabeth	NIFEDIPINE	nifedipine	CAPSULE;ORAL	072579-001	Jan 8, 1991	AB	RX	No	No
Alembic	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	216896-002	Nov 18, 2022	AB2	RX	No	No

Expired US Patents for nifedipine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	5,264,446
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993	5,264,446
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	4,765,989
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	4,765,989
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	4,327,725
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993	5,264,446
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-001	Approved Prior to Jan 1, 1982	3,644,627

Nifedipine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nifedipine

Market Overview

Nifedipine, a calcium channel blocker, is widely used to treat various cardiovascular conditions, including hypertension, angina, and Raynaud’s phenomenon. The global nifedipine market is poised for significant growth driven by several key factors.

Market Size and Growth Projections

The global nifedipine market is estimated to experience substantial growth over the next few years. Here are some key projections:

• By 2027, the market size is expected to reach $1.7 billion, growing at a CAGR of 4.1% during the forecast period 2022-2027[1].
• Another estimate suggests the market will be valued at $1,049.6 million in 2023 and is expected to reach $1,967.2 million by 2030, with a CAGR of 9.4% during the forecast period[3].
• A more long-term projection indicates the market could reach $1,661.5 million by 2032, growing at a CAGR of 8.1% from 2023 to 2032[4].

Geographical Segmentation

The nifedipine market is geographically segmented into several regions, each with its own growth dynamics:

• North America: Currently holds the largest market share, driven by high rates of obesity and related health issues such as hypertension and cardiovascular diseases. The U.S. dominates this segment due to its high obesity rates, with around 36.20% of adults facing overweight problems[1][5].
• Asia-Pacific: Expected to be the fastest-growing segment, driven by an expanding older population, especially in countries like India and China, and improvements in healthcare infrastructure. This region is anticipated to exhibit a CAGR of 8.8% over the forecast period[1][5].

Market Drivers

Several factors are driving the growth of the nifedipine market:

• Increasing Prevalence of Chronic Diseases: Conditions such as hypertension, heart failure, and arrhythmias are becoming more prevalent, driving the demand for nifedipine[3][4].
• Rising Healthcare Expenditure: Increased spending on healthcare, particularly in emerging markets, is boosting the market for nifedipine[3][5].
• Improving Healthcare Infrastructure: Governments in emerging markets are investing heavily in healthcare infrastructure, making nifedipine more accessible[4][5].

Market Restraints

Despite the growth potential, there are several factors that could restrain the market:

• Side Effects: Nifedipine is associated with various side effects, including nausea, weight gain, and serious conditions like liver damage and breathing difficulties. These side effects can deter some patients and reduce market growth[1][3].
• Generic Competition: The availability of generic versions of nifedipine affects pricing and competition within the market, often leading to lower prices and reduced revenue for branded products[3][4].
• Regulatory Challenges: Stringent regulations for the approval of new drug formulations can act as a barrier to market growth[3][4].

Technological Advancements

Advances in pharmaceutical technologies are expected to positively impact the market:

• Novel Drug Delivery Mechanisms: Extended-release and controlled-absorption formulations of nifedipine can improve patient compliance and offer a competitive edge in the market[3][4].
• Improved Formulations: New formulations that enhance efficacy, reduce side effects, or offer convenient dosage options can gain significant market share[4].

Patient Adherence and Compliance

Patient adherence to prescribed medications is crucial for the market dynamics of nifedipine:

• Poor adherence can lead to treatment failure or complications, impacting the overall market. Strategies to improve patient education and adherence are essential for consistent usage of nifedipine[4].

Emerging Markets and Healthcare Infrastructure

Emerging markets are playing a significant role in the growth of the nifedipine market:

• Growing healthcare infrastructure and increased awareness about cardiovascular health in countries like India and China are driving market expansion. Initiatives such as India's National Health Policy aim to reduce early cardiovascular deaths, further boosting the market[5].

Partnerships and Acquisitions

Strategic partnerships and acquisitions are shaping the competitive landscape:

• For example, Glenmark Pharmaceuticals acquired the nifedipine business of Actavis, enhancing its portfolio and presence in the pharmaceutical market[4].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the nifedipine market:

• While the pandemic highlighted the importance of chronic disease management, it also posed challenges such as supply chain disruptions and changes in healthcare priorities. However, the long-term trend indicates continued growth driven by increased healthcare needs[4][5].

Financial Trajectory

The financial trajectory of the nifedipine market is characterized by steady growth:

• The market is expected to grow from approximately $1 billion in 2023 to nearly $2 billion by 2030, driven by increasing demand and technological advancements[3][4].

Key Takeaways

• The global nifedipine market is driven by the increasing prevalence of chronic diseases and improvements in healthcare infrastructure.
• North America currently dominates the market, but Asia-Pacific is expected to be the fastest-growing segment.
• Technological advancements in drug delivery mechanisms and patient adherence strategies are crucial for market growth.
• Generic competition and regulatory challenges are key restraints to market growth.
• Emerging markets and strategic partnerships are playing a significant role in shaping the market.

Frequently Asked Questions (FAQs)

Q1: What is the primary use of nifedipine?

• Nifedipine is primarily used to treat conditions such as hypertension, angina, and Raynaud’s phenomenon by preventing calcium from moving through the arteries.

Q2: Which region is expected to be the fastest-growing segment for the nifedipine market?

• The Asia-Pacific region is anticipated to be the fastest-growing segment, driven by an expanding older population and improvements in healthcare infrastructure.

Q3: What are the major side effects associated with nifedipine?

• Nifedipine is associated with side effects such as nausea, weight gain, and serious conditions like liver damage and breathing difficulties.

Q4: How does generic competition impact the nifedipine market?

• Generic competition affects pricing and competition within the market, often leading to lower prices and reduced revenue for branded products.

Q5: What role do technological advancements play in the nifedipine market?

• Technological advancements, such as novel drug delivery mechanisms and improved formulations, can enhance efficacy, reduce side effects, and improve patient compliance, thereby gaining significant market share.

Cited Sources

1. IndustryARC - Nifedipine Market Size Report, 2022-2027
2. AHJ - 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA
3. Coherent Market Insights - Nifedipine Medication Market - Price, Size, Share & Growth
4. Custom Market Insights - Global Nifedipine Market Size Reach $1,661.5 Million 2032
5. Straits Research - Nifedipine Market Size, Share, Trends, Forecast Report 2032