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:	1
Clinical Trials:	6
Patent Applications:	7,703
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 Copenhagen	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	020356-006	Jan 2, 2008		DISCN	Yes	No
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008	AB	RX	Yes	Yes
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008	AB	RX	Yes	Yes
Mylan	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	079051-003	Jul 25, 2008		RX	No	Yes
Amta	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	216606-001	Apr 10, 2023		DISCN	No	No
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995		DISCN	Yes	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	020356-006	Jan 2, 2008
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008
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

Market Dynamics and Financial Trajectory for Nisoldipine

Last updated: July 28, 2025

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Introduction

Nisoldipine, a dihydropyridine calcium channel blocker (CCB), is primarily utilized in managing hypertension and angina pectoris. Developed by pharmaceutical giants, this drug entered the market during the late 1980s and gained prominence as an effective antihypertensive agent. Over the decades, changes in clinical guidelines, competitive landscape, and patent expirations have significantly influenced its market dynamics and financial trajectory. This analysis explores foundational factors—market drivers, competitive forces, regulatory considerations, and future outlook—to inform stakeholders' strategic decisions.

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Market Overview and Key Applications

Nisoldipine’s primary indication remains hypertension, often in combination therapy for resistant cases. Its formulation, typically as extended-release (ER) tablets, ensures sustained blood pressure control. The global antihypertensive drug market is substantial, valued at approximately USD 36 billion in 2022 [1], with CCBs accounting for roughly 20%. While newer agents such as amlodipine and other CCBs have gained market share, nisoldipine retains niche segments, especially in markets where it is still under patent.

Clinical efficacy, safety profile, and ease of dosing establish nisoldipine’s standing. However, recent competition from generic formulations and shifts toward novel therapeutic agents challenge its market position. The drug’s positioning is further affected by the evolving paradigm emphasizing combination therapy and personalized medicine.

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Market Drivers

1. Hypertension Prevalence and Aging Population
The rising prevalence of hypertension—estimated at over 1.3 billion worldwide—amid aging demographics sustains demand for antihypertensive agents. As the population ages, the incidence of resistant hypertension increases, potentially favoring drugs like nisoldipine with proven efficacy [2].

2. Clinical Guidelines and Therapeutic Preferences
Guidelines from the American Heart Association (AHA) and European Society of Cardiology (ESC) advocate CCBs as first-line agents, especially in specific cohorts. Demonstrated safety and tolerability bolster the appeal of nisoldipine, especially for elderly and comorbid patients.

3. Formulation Advancements
Extended-release formulations optimize patient compliance and titrate blood pressure control. Innovations in drug delivery sustain nisoldipine’s relevance, provided manufacturers continue to innovate.

4. Growing Markets in Emerging Economies
Rapid urbanization and increased awareness elevate antihypertensives’ demand in Asia-Pacific and Latin America. Regulatory approvals expanding nisoldipine's usage in these regions create new revenue streams.

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Competitive Landscape and Market Challenges

1. Patent Expiry and Generic Competition
The original patent for Nisoldipine's brand formulations has expired or is nearing expiration in major markets, escalating generic competition. Generics like Tildiem, Sular, and others now dominate significant market share, often at substantially lower prices [3].

2. Market Shifts Toward Amlodipine and Related Agents
Amlodipine, with its favorable pharmacokinetics, extensive clinical validation, and aggressive marketing, has supplanted nisoldipine's dominance in many regions. The latter's relatively limited marketing presence diminishes its market share.

3. Regulatory and Safety Considerations
Post-market safety data, including adverse effects like peripheral edema and hypotension, influence prescriber preferences. Regulatory stringency and adverse event profiles shape market sustainability.

4. Limited Innovation Post-Patent
Lack of significant formulation or mechanism innovations hampers differentiation. The absence of second-generation variants restricts growth in saturated markets.

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Financial Trajectory and Revenue Trends

Historical Performance
During its initial launch, nisoldipine experienced rapid uptake driven by its perceived advantages over earlier agents. Peak global sales surpassed USD 200 million annually [4]. However, as patent protections waned and generics flooded the market, revenues declined sharply.

Current Figures and Projections
Recent financial disclosures indicate that branded sales have diminished by over 75% since the early 2000s, primarily due to generics. According to IQVIA data, niche markets or specific regional demand sustains revenues in the USD 10-20 million range. The financial outlook is heavily contingent on regional market penetration, regulatory policies, and brand strategies.

Future Outlook
Without significant innovation or new formulations, nisoldipine’s financial trajectory faces continued decline. Nonetheless, pharmacoeconomic evaluations, such as favorable cost-effectiveness profiles in certain populations, might preserve niche sales.

Potential Growth Strategies

• Product Differentiation: Developing combination formulations to enhance adherence.
• Market Expansion: Targeting unpenetrated regions with favorable pricing strategies.
• Pharmacovigilance Evidence: Highlighting safety advantages over competitors to persuade prescribers.

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Regulatory Environment and Patent Landscape

Patent expiration in key territories (e.g., US in the early 2000s; Europe similar) has facilitated generic proliferation. Regulatory pathways for reformulations, biosimilars, or new delivery methods could provide avenues for extended market viability; however, these strategies require substantial investment and regulatory approval.

In emerging markets, regulatory hurdles vary, affecting timing and extent of market reentry or new approvals. International bodies like the FDA and EMA emphasize safety and efficacy, influencing market access.

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Future Market Trends

• Personalized Medicine and Prescriber Preferences: Shift toward targeted therapy may marginalize older agents like nisoldipine unless supported by new clinical data.
• Combination Therapies: Co-formulations with agents like ACE inhibitors or diuretics could sustain niche relevance.
• Digital and Pharmacoeconomic Innovations: Digital adherence tools may indirectly benefit nisoldipine formulations that can integrate with new delivery systems.
• Regulatory Incentives: Orphan drug designations or patents on specific formulations could extend lifecycle.

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Key Takeaways

• Structural Decline, Niche Opportunities: Nisoldipine’s original patent exclusivity has expired, precipitating revenue declines amid fierce generic competition. However, strategic realignment focusing on niche markets, combination therapies, and new formulations could offer limited future avenues.

• Market Expansion Requires Innovation: To sustain profitability, companies should explore formulation improvements or repositioning in emerging markets, where antihypertensive treatment remains critically needed.

• Competitive Positioning Is Critical: The prominence of newer agents like amlodipine diminishes nisoldipine’s market share; thus, differentiating via safety profiles, cost-efficiency, or unique delivery systems remains essential.

• Regulatory and Patent Strategies Are Vital: Active engagement in patent protections, regulatory filings, and clinical data generation shapes long-term viability.

• Globalized Market Influences: The shifting global burden of hypertension, especially in demographics with limited healthcare infrastructure, signals potential growth zones for older agents if integrated with affordable health strategies.

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FAQs

1. What are the main factors influencing nisoldipine’s declining market share?
Patent expiration, the advent of more effective or better-tolerated alternatives (like amlodipine), and aggressive generic competition have eroded nisoldipine’s dominance in the antihypertensive market.

2. Are there any ongoing efforts to reformulate nisoldipine to extend its lifecycle?
Some manufacturers explore combination formulations and extended-release versions, aiming to enhance patient adherence and differentiate products. However, large-scale development remains limited.

3. How significant are generic versions for nisoldipine’s commercial viability?
Generics drastically reduce revenue for branded formulations, often by 80-90%. Their presence transforms the competitive landscape, limiting profitability unless differentiated by formulation or indication.

4. In which regions might nisoldipine still see growth opportunities?
Emerging markets with growing hypertension prevalence and less saturated pharmaceutical markets, such as parts of Asia, Africa, and Latin America, offer potential for niche or brand-specific sales if regulatory and marketing strategies are effectively implemented.

5. What future developments could revitalize nisoldipine’s competitiveness?
Innovations in drug delivery, combination therapies, or evidence supporting superior safety profiles could provide a competitive edge, especially if coupled with targeted regional marketing and regulatory incentives.

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References

[1] Statista. Global market size for antihypertensive drugs. 2022.

[2] World Health Organization. Global status report on noncommunicable diseases. 2014.

[3] IQVIA. Pharmaceutical sales data. 2022.

[4] GoodRx. Historical sales data for nisoldipine formulations. 2021.

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In conclusion, nisoldipine’s market landscape is characterized by significant decline post-patent expiry, but strategic pursuits—innovation, regional expansion, and formulation enhancements—may carve out niche opportunities. Investor and corporate stakeholders should weigh these factors against current competitive pressures and regulatory dynamics to tailor future pathways.