NIMODIPINE - Generic Drug Details

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

Nimodipine is the generic ingredient in three branded drugs marketed by Bionpharma, Heritage, Sofgen Pharms, Sun Pharm Inds Inc, Thepharmanetwork Llc, Bayer Pharms, Alkem Labs Ltd, Annora Pharma, and Azurity, and is included in nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for nimodipine. Four suppliers are listed for this compound.

Summary for NIMODIPINE

US Patents:	6
Tradenames:	3
Applicants:	9
NDAs:	9
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	52
Patent Applications:	7,325
Drug Prices:	Drug price trends for NIMODIPINE
What excipients (inactive ingredients) are in NIMODIPINE?	NIMODIPINE excipients list
DailyMed Link:	NIMODIPINE at DailyMed

See drug prices for NIMODIPINE

Recent Clinical Trials for NIMODIPINE

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

Sponsor	Phase
Nebraska Methodist Health System	PHASE3
Centre Hospitalier St Anne	PHASE3
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	PHASE2

See all NIMODIPINE clinical trials

Pharmacology for NIMODIPINE

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

Medical Subject Heading (MeSH) Categories for NIMODIPINE

Antihypertensive Agents

Calcium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for NIMODIPINE

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

Paragraph IV (Patent) Challenges for NIMODIPINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NYMALIZE	Oral Solution	nimodipine	6 mg/mL	203340	1	2021-11-29

US Patents and Regulatory Information for NIMODIPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-001	May 10, 2013		DISCN	Yes	No
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	AB	RX	Yes	Yes			Y
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988		DISCN	Yes	No
Alkem Labs Ltd	NIMODIPINE	nimodipine	SOLUTION;ORAL	213409-001	Jan 22, 2025	AB	RX	No	No
Thepharmanetwork Llc	NIMODIPINE	nimodipine	CAPSULE;ORAL	090103-001	Apr 7, 2014	AB	RX	No	No
Heritage	NIMODIPINE	nimodipine	CAPSULE;ORAL	077811-001	May 2, 2007	AB	RX	No	No
Sun Pharm Inds Inc	NIMODIPINE	nimodipine	CAPSULE;ORAL	077067-001	Apr 17, 2007		DISCN	No	No

Expired US Patents for NIMODIPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988

Market Dynamics and Financial Trajectory for Nimodipine

Last updated: July 28, 2025

Introduction

Nimodipine, a calcium channel blocker initially developed for hypertension, has established a niche application in neurology, particularly in preventing delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH). Its unique pharmacological profile has propelled sustained interest in both domestic and international markets. This analysis synthesizes current market dynamics, regulatory trajectories, competitive landscape, and financial prospects for nimodipine to facilitate strategic decision-making in the evolving pharmaceutical sphere.

Historical Background and Clinical Applications

Nimodipine received FDA approval in 1988, primarily marketed under the brand name Nimotop®, targeting subarachnoid hemorrhage management. Its lipophilic nature allows preferential penetration of neuronal tissue, reducing cerebral vasospasm — a significant contributor to morbidity and mortality post-aSAH [1].

Despite its established clinical utility, nimodipine's therapeutic scope remains relatively narrow, with regulatory approvals largely confined to specific indications. Nonetheless, off-label use and ongoing research exploring neuroprotective effects in traumatic brain injury (TBI) and ischemic stroke have contributed to sustained market interest.

Market Dynamics

Regulatory Landscape

Global regulatory frameworks underpin the drug’s market viability. The U.S. Food and Drug Administration (FDA) recognizes nimodipine for subarachnoid hemorrhage. Similar approvals exist in Europe and Asia, albeit with regional nuances influencing market access and pricing.

The patent landscape influences commercialization strategies. Notably, the original patent for Nimotop® expired in the early 2000s, prompting generic entries that have now driven down costs and expanded accessibility. However, proprietary formulations or delivery mechanisms still hold patent protection, offering potential revenue streams for innovative derivatives.

Competitive Environment

Nimodipine faces competition from other vasospasm management agents, including oral and intravenous formulations of nimodipine and alternative calcium channel blockers. Currently, no direct substitutes surpass nimodipine’s efficacy in preventing cerebral vasospasm, reinforcing its market position within niche indications.

Emerging generics have disrupted pricing parity, leading to increased market penetration, especially in cost-sensitive regions. Additionally, developmental pipelines exploring combination therapies and alternative delivery systems suggest a dynamic competitive horizon.

Market Drivers

• Clinical validation of nimodipine’s efficacy in preventing neurological deterioration post-aSAH sustains demand.
• Expanding indications, including neuroprotection in TBI, could enlarge market size.
• Rising incidence of cerebrovascular events globally, driven by aging populations and lifestyle factors, sustains long-term demand.
• Regulatory support in emerging markets facilitates increased distribution.

Market Limitations

• Limited patent protection reduces incentivization for large-scale investment beyond generic manufacturing.
• Side-effect profile, including hypotension, limits widespread use, especially in fragile populations.
• Off-label use variability and lack of updated clinical guidelines can hinder uniform adoption.
• Manufacturing complexities and supply chain disruptions impact market stability.

Financial Trajectory

Revenue Trends

Data indicate that nimodipine's global sales amount to approximately $200 million annually, with North America accounting for roughly 60% of the market, driven by high clinical adoption in acute neurological care [2]. The entry of generics post-patent expiry has led to price erosion, with some markets experiencing reductions of up to 50%.

Forecasted Growth

Projections suggest a compound annual growth rate (CAGR) of around 3-5% over the next five years, primarily fueled by:

• Increasing neurological trauma cases globally.
• Broadened clinical research suggesting utility in other neurovascular conditions.
• Expansion into emerging markets with growing healthcare infrastructure.

However, this growth remains tempered by pricing pressures, regulatory hurdles, and therapeutic competition.

Investment and Development Outlook

Pharmaceutical companies are increasingly investing in reformulations, such as transdermal patches and intravenous formulations, to improve patient compliance and broaden applicability. Such innovation could unlock additional revenue streams, offsetting generic price erosion.

Research into neuroprotective roles of nimodipine in TBI and stroke continues, with some clinical trials indicating promising outcomes. Successful trial outcomes could significantly alter its market trajectory.

Pricing and Reimbursement Dynamics

Reimbursement policies heavily influence profitability. Countries with universal healthcare systems tend to negotiate lower prices, constraining margins. Conversely, in privatized systems or markets with less regulation, premium pricing can sustain higher revenues.

Regulatory and Patent Considerations

Patent expiration in major regions has catalyzed generic proliferation. Nonetheless, newer formulations and delivery systems may secure secondary patents, extending commercial exclusivity. Regulatory agencies increasingly emphasize evidence for new indications, which can both open and challenge market entry strategies.

Conclusion: Strategic Outlook

The nimodipine market embodies a mature yet evolving therapeutic niche. Its sustained relevance hinges on clinical validation, innovative formulations, and geographic expansion. While patent expiries have commoditized existing therapies, opportunity persists in novel delivery systems and new indications, notably in neurovascular protection.

Key Takeaways

• Nimodipine remains integral in managing cerebral vasospasm post-aSAH, with a stable yet mature global market.
• Patent expirations have accelerated generic entry, exerting downward pressure on prices but expanding access.
• Emerging clinical research and innovative formulations poised to extend its therapeutic application could rejuvenate growth.
• Regulatory heterogeneity across regions influences market access and pricing strategies.
• The evolving competitive landscape necessitates continuous innovation and strategic positioning to maximize revenue streams.

FAQs

1. How does patent expiration affect nimodipine’s market?
Patent expiry typically leads to increased generic competition, lowering prices and expanding access but reducing profit margins for brand-name manufacturers. However, secondary patents on formulations or delivery methods can temporarily sustain exclusivity.

2. What are the primary clinical indications for nimodipine?
Nimodipine is primarily indicated for preventing cerebral vasospasm following subarachnoid hemorrhage. Off-label research explores its potential in traumatic brain injury and ischemic stroke relief.

3. Are there upcoming formulations or delivery systems for nimodipine?
Yes, pharmaceutical development explores transdermal patches, intravenous formulations, and sustained-release systems to improve therapeutic efficacy and patient compliance.

4. How do regional regulations impact nimodipine’s market size?
Different regulatory standards influence approval timelines and reimbursement rates. Markets with streamlined approval processes and favorable reimbursement policies facilitate better access and profitability.

5. What emerging research could influence nimodipine’s future market?
Ongoing clinical trials investigating neuroprotective effects in TBI and stroke hold potential to expand its approved indications, thereby increasing market scope and revenues.

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References

[1] Davis, M. (2017). "Pharmacology Review of Nimodipine in Cerebral Vasospasm." Neuropharmacology Journal.
[2] Industry Reports. (2022). "Global Cardiology & Neurovascular Drug Market Analysis." Pharma Intelligence.