ADALAT Drug Patent Profile

Which patents cover Adalat, and what generic alternatives are available?

Adalat is a drug marketed by Bayer Pharms and Norwich and is included in two NDAs.

The generic ingredient in ADALAT 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

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

Summary for ADALAT

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	29
Patent Applications:	1,419
Drug Prices:	Drug price information for ADALAT
DailyMed Link:	ADALAT at DailyMed

See drug prices for ADALAT

Recent Clinical Trials for ADALAT

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

Sponsor	Phase
Cao Yu	Phase 1
Jing Liu	Phase 4
The University of Texas Medical Branch, Galveston	Phase 4

See all ADALAT clinical trials

US Patents and Regulatory Information for ADALAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985		DISCN	No	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993		DISCN	Yes	No
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-002	Sep 17, 1986		DISCN	No	No

Expired US Patents for ADALAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985	3,644,627
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-002	Sep 17, 1986	3,784,684
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985	3,784,684

International Patents for ADALAT

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

Country	Patent Number	Title	Estimated Expiration
Kenya	2756	CAPSULES COMPRISING A CORONARY-DILATING COMPOUND
Belgium	787951
Luxembourg	65929

ADALAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Adalat (Nifedipine)

Introduction

Adalat, a brand name for the medication nifedipine, is a calcium channel blocker widely used to treat hypertension, angina, and other heart-related conditions. This article delves into the market dynamics and financial trajectory of Adalat, highlighting key drivers, challenges, and future projections.

Market Size and Growth Projections

The global nifedipine medication market, which includes Adalat, is expected to exhibit significant growth. As of 2022, the market was valued at approximately $1,094.2 million and is projected to reach $1,936.9 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 9.4% during the forecast period[1][4].

Market Drivers

Growing Prevalence of Hypertension

The increasing prevalence of hypertension is a major driver for the nifedipine market. Hypertension is a common condition that requires long-term management, making nifedipine a frequently prescribed medication[1][4].

Increasing Cardiovascular Diseases

The rise in cardiovascular diseases, including heart failure and angina, further boosts the demand for nifedipine. As the global population ages, the incidence of these diseases is expected to increase, driving market growth[1][4].

Growing Geriatric Population

The expanding geriatric population is another significant factor. Older adults are more likely to suffer from cardiovascular diseases, thereby increasing the demand for medications like Adalat[1].

Expansion of Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in emerging markets, enhance access to medications like nifedipine. This expansion is crucial for market growth as it increases the reach and availability of the drug[1][4].

Market Segments

Dosage Form

The extended-release tablets segment is expected to dominate the market due to their efficacy in relaxing blood vessels and reducing the workload on the heart. Adalat CC, an extended-release formulation of nifedipine, is particularly popular for its once-daily dosing regimen[1][5].

Indication

Hypertension is the primary indication for nifedipine, and this segment is expected to hold a dominant position in the market. Nifedipine is commonly prescribed for hypertension management due to its effectiveness in lowering blood pressure[1].

Key Developments

New Product Launches

Recent developments include the restart of the supply of 30mg tablets of Adalat LA prolonged-release by a Germany-based producer in 2021. Additionally, Alembic Pharmaceuticals received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for nifedipine extended-release tablets in 2022[1][4].

Acquisitions and Partnerships

Glenmark Pharmaceuticals' acquisition of the nifedipine business of Actavis in 2019 and its partnership with Sandoz in 2017 are significant strategic moves. These collaborations have enhanced Glenmark's portfolio and strengthened its market presence[1][4].

Market Opportunities

Shift Towards Combination Therapy

The increasing preference for combination therapies that include nifedipine along with other antihypertensive drugs is expected to open new avenues for market growth. These combination therapies offer improved outcomes in managing hypertension[1].

Market Restraints

Side Effects and Safety Concerns

Long-term use of calcium channel blockers like nifedipine can lead to side effects and safety concerns, which may hamper market growth. Monitoring and managing these side effects are crucial for maintaining patient adherence and compliance[1].

Economic and Clinical Outcomes

Cost Savings

Studies have shown that switching from one calcium channel blocker to another, such as from Procardia XL to Adalat CC, can result in significant cost savings without compromising blood pressure control or increasing adverse drug reactions. For instance, a study in Pennsylvania indicated potential savings of over $2.5 million annually for Medicaid patients[2].

Technological Advancements

Improved Formulations

Advances in pharmaceutical technologies, such as enhanced drug delivery systems, can improve the efficacy and reduce the side effects of nifedipine. New formulations that offer convenient dosage options or improved patient compliance are likely to gain market share[4].

Regulatory Environment

Safety Standards and New Indications

Changes in regulatory policies and approvals can significantly impact the market. Updates in safety standards or new indications approved by regulatory bodies can influence market growth and competitiveness of nifedipine[4].

Emerging Markets and Healthcare Infrastructure

Growing Healthcare Access

The expansion of healthcare infrastructure in emerging markets and increased awareness about cardiovascular health contribute to the growth of the nifedipine market. Improved access to healthcare services and medications in developing countries drives market expansion[1][4].

Financial Performance

Bayer Group's Pharmaceuticals Division

Bayer, the manufacturer of Adalat, reported mixed results in its pharmaceuticals division. While sales of prescription medicines increased by 3.9%, Adalat sales declined by 23% globally due to tender procedures in China. However, the division's overall performance was positive, driven by other products[3].

Market Dynamics and Patient Adherence

Patient Compliance

Patient adherence to prescribed medications is a critical factor influencing the market dynamics of nifedipine. Poor adherence can lead to treatment failure or complications, underscoring the need for strategies to improve patient education and compliance[4].

Global Economic Factors

Economic Impact on Healthcare Spending

Global economic conditions can significantly impact the nifedipine market. Economic downturns may reduce healthcare spending, affecting the affordability and accessibility of medications, while economic growth can increase demand for cardiovascular medications[4].

Key Takeaways

• The global nifedipine market, including Adalat, is projected to grow at a CAGR of 9.4% from 2022 to 2030.
• The market is driven by the growing prevalence of hypertension, increasing cardiovascular diseases, and the expanding geriatric population.
• Extended-release formulations and hypertension management are key segments driving market growth.
• New product launches, acquisitions, and partnerships are strategic moves enhancing market presence.
• Combination therapies and technological advancements offer new market opportunities.
• Side effects and safety concerns are significant restraints that need to be managed.

FAQs

1. What is the expected market size of the global nifedipine market by 2030?

   • The global nifedipine market is expected to reach $1,936.9 million by 2030[1].

2. What are the primary drivers of the nifedipine market growth?

   • The primary drivers include the growing prevalence of hypertension, increasing cardiovascular diseases, and the expanding geriatric population[1][4].

3. Which dosage form is expected to dominate the nifedipine market?

   • The extended-release tablets segment is expected to dominate the market due to its efficacy and once-daily dosing regimen[1][5].

4. How do regulatory changes impact the nifedipine market?

   • Changes in regulatory policies and approvals can influence market growth and competitiveness by updating safety standards or approving new indications[4].

5. What are the potential cost savings from switching between different calcium channel blockers?

   • Switching from Procardia XL to Adalat CC can result in significant cost savings, such as over $2.5 million annually for Medicaid patients in Pennsylvania[2].

Sources

1. Coherent Market Insights: Nifedipine Medication Market to Hit US$ 1,936.9 Million Globally by 2030 at 9.4 CAGR[1].
2. PubMed: The costs and effects of switching calcium channel blockers[2].
3. Bayer: First-quarter performance as expected[3].
4. Custom Market Insights: Global Nifedipine Market Size Reach $1,661.5 Million 2032[4].
5. FDA: Adalat CC (nifedipine) tablets label[5].