Nisoldipine - Generic Drug Details

What are the generic sources for nisoldipine and what is the scope of patent protection?

Nisoldipine is the generic ingredient in two branded drugs marketed by Amta, Mylan, and Covis, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for nisoldipine. Three suppliers are listed for this compound.

Summary for nisoldipine

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	6
Patent Applications:	6,915
Drug Prices:	Drug price trends for nisoldipine
What excipients (inactive ingredients) are in nisoldipine?	nisoldipine excipients list
DailyMed Link:	nisoldipine at DailyMed

See drug prices for nisoldipine

Recent Clinical Trials for nisoldipine

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

Sponsor	Phase
Menarini International Operations Luxembourg SA	Phase 4
Mylan Pharmaceuticals	Phase 1
Steno Diabetes Center	Phase 4

See all nisoldipine clinical trials

Pharmacology for nisoldipine

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists
Physiological Effect	Decreased Blood Pressure

Medical Subject Heading (MeSH) Categories for nisoldipine

Antihypertensive Agents

Calcium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for nisoldipine

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

Paragraph IV (Patent) Challenges for NISOLDIPINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SULAR	Extended-release Tablets	nisoldipine	8.5 mg and 17 mg	020356	1	2009-03-02
SULAR	Extended-release Tablets	nisoldipine	25.5 mg and 34 mg	020356	1	2008-11-28
SULAR	Extended-release Tablets	nisoldipine	20 mg and 30 mg	020356	1	2007-11-07
SULAR	Extended-release Tablets	nisoldipine	40 mg	020356	1	2007-06-11

US Patents and Regulatory Information for nisoldipine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-002	Feb 2, 1995		DISCN	Yes	No
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-003	Feb 2, 1995		DISCN	Yes	No
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995		DISCN	Yes	No
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-006	Jan 2, 2008		DISCN	Yes	No
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008	AB	RX	Yes	Yes
Mylan	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	079051-002	Jul 25, 2008		RX	No	No
Mylan	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	091001-001	Jan 26, 2011	AB	RX	No	No

Expired US Patents for nisoldipine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-003	Feb 2, 1995
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-006	Jan 2, 2008
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-002	Feb 2, 1995
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008

Market Dynamics and Financial Trajectory for Nisoldipine

Introduction

Nisoldipine, a 1,4-dihydropyridine calcium channel blocker, is primarily used in the treatment of hypertension. Here, we will delve into the market dynamics and financial trajectory of nisoldipine, exploring its current market size, growth projections, and the factors influencing its demand.

Market Size and Growth Projections

The global nisoldipine market has been valued at a significant level and is expected to grow steadily over the coming years. As of 2023, the nisoldipine market was valued at USD 100 billion and is projected to reach USD 140 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[4].

Drivers of Market Growth

Several factors are driving the growth of the nisoldipine market:

Increasing Prevalence of Hypertension

The rising incidence of hypertension, particularly in aging populations, is a significant driver. Countries like India and China are experiencing an increase in chronic diseases due to their aging populations, which is expected to boost the demand for antihypertensive medications like nisoldipine[3].

Healthcare Infrastructure Development

Government investments in healthcare infrastructure are also contributing to the growth. Improved healthcare facilities and increased access to medical treatments are enhancing the market for nisoldipine and other antihypertensive drugs[3].

Technological Advancements

Advancements in pharmaceutical research and the use of cutting-edge technology are further driving the market. These advancements help in the development of more effective and safer medications, including nisoldipine[3].

Distribution Channels

The market for nisoldipine is distributed through various channels, including hospital pharmacies, retail pharmacies, and other distribution networks. Hospital pharmacies have dominated the market, and this trend is expected to continue with a faster CAGR during the forecast period[3].

Regional Market Dynamics

Asia Pacific Market

The Asia Pacific region is expected to see significant growth in the nisoldipine market. This region is projected to grow at a high rate due to the increasing prevalence of chronic diseases and improvements in healthcare infrastructure. By 2030, the Asia Pacific nifedipine market, which includes similar dihydropyridine calcium channel blockers like nisoldipine, is estimated to reach a valuation of USD 440.96 million, growing at a CAGR of 8.7% from 2022 to 2030[3].

Competitive Landscape

Nisoldipine operates in a competitive market alongside other calcium channel blockers such as nifedipine. The market for these drugs is driven by similar factors, including the growing need for antihypertensive treatments and advancements in pharmaceutical technology. The global nifedipine market, for example, was valued at USD 856.66 million in 2020 and is expected to reach USD 1,792.36 million by 2029, growing at a CAGR of 8.49%[3].

Pricing and Cost Considerations

The pricing of nisoldipine varies based on the dosage and formulation. For instance, the cost of nisoldipine extended-release tablets can range from USD 4.13 to USD 6.84 per tablet, depending on the dosage and the specific product[2].

Adverse Effects and Safety Considerations

While nisoldipine is generally well-tolerated, it can have adverse effects, including minor and major events. In clinical studies, the incidence of adverse events was noted to be similar across placebo and nisoldipine groups, although serious adverse events such as unstable angina and sudden death were reported in some cases[1].

Regulatory and Pharmacological Considerations

Government regulations and pharmacological repercussions can impact the market growth. For example, blackbox warnings and adverse reaction data are crucial for decision-making and can influence the prescription rates of nisoldipine[2].

Conclusion

The market for nisoldipine is poised for steady growth driven by increasing demand for antihypertensive medications, advancements in pharmaceutical technology, and improvements in healthcare infrastructure. However, it is crucial to consider the potential adverse effects and regulatory factors that could influence market dynamics.

Key Takeaways

• The global nisoldipine market is valued at USD 100 billion as of 2023 and is expected to reach USD 140 billion by 2031.
• The market is driven by the increasing prevalence of hypertension, especially in aging populations.
• Asia Pacific is a key region for growth, with a projected CAGR of 8.7% from 2022 to 2030.
• Hospital pharmacies dominate the distribution channels.
• Adverse effects and regulatory considerations are important factors in market dynamics.

FAQs

What is the primary use of nisoldipine?

Nisoldipine is primarily used as a monotherapy or in combination with other drugs for the treatment of hypertension[2].

How does nisoldipine work?

Nisoldipine acts by inhibiting the influx of calcium into vascular smooth muscle cells, preventing calcium-dependent smooth muscle contraction and subsequent vasoconstriction[2].

What are the potential adverse effects of nisoldipine?

Nisoldipine can cause minor and major adverse events, including unstable angina and sudden death in some cases[1].

What is the projected market size of nisoldipine by 2031?

The nisoldipine market is expected to reach USD 140 billion by 2031, growing at a CAGR of 5% from 2024 to 2031[4].

Which region is expected to see significant growth in the nisoldipine market?

The Asia Pacific region is expected to see significant growth, driven by the increasing prevalence of chronic diseases and improvements in healthcare infrastructure[3].

Sources

1. Double-blind, dose-response, placebo-controlled multicenter study ... - PubMed
2. Nisoldipine: Uses, Interactions, Mechanism of Action - DrugBank
3. Asia Pacific Nifedipine Market Size, Analysis, Share to [2022-2030] - Straits Research
4. Nisoldipine Market Size and Projections - Market Research Intellect
5. Role of action potential configuration and the contribution of Ca 2+ ... - PMC