NIMBEX Drug Patent Profile

When do Nimbex patents expire, and when can generic versions of Nimbex launch?

Nimbex is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in NIMBEX is cisatracurium besylate. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nimbex

A generic version of NIMBEX was approved as cisatracurium besylate by SANDOZ INC on February 3^rd, 2012.

Summary for NIMBEX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	13
Patent Applications:	474
Drug Prices:	Drug price information for NIMBEX
What excipients (inactive ingredients) are in NIMBEX?	NIMBEX excipients list
DailyMed Link:	NIMBEX at DailyMed

See drug prices for NIMBEX

Recent Clinical Trials for NIMBEX

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

Sponsor	Phase
Mahidol University	Phase 4
Makassed General Hospital	N/A
Assiut University	Phase 2/Phase 3

See all NIMBEX clinical trials

US Patents and Regulatory Information for NIMBEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	NIMBEX	cisatracurium besylate	INJECTABLE;INJECTION	020551-001	Dec 15, 1995		DISCN	Yes	No
Abbvie	NIMBEX PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	020551-003	Dec 15, 1995		DISCN	Yes	No
Abbvie	NIMBEX PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	020551-002	Dec 15, 1995		DISCN	Yes	No

Expired US Patents for NIMBEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NIMBEX	cisatracurium besylate	INJECTABLE;INJECTION	020551-001	Dec 15, 1995	4,179,507
Abbvie	NIMBEX	cisatracurium besylate	INJECTABLE;INJECTION	020551-001	Dec 15, 1995	5,453,510

International Patents for NIMBEX

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

Country	Patent Number	Title	Estimated Expiration
Denmark	149751
Italy	1249677	AGENTI BLOCCANTI NEUROMUSCOLARI E PROCEDIMENTO DI PREPARAZIONE
Italy	RM910518

Market Dynamics and Financial Trajectory for NIMBEX (Nimodipine)

Last updated: July 28, 2025

Introduction

NIMBEX, the proprietary formulation of nimodipine, functions primarily as an anti-vascular agent for preventing and treating vasospasm associated with subarachnoid hemorrhage (SAH). As a calcium channel blocker, nimodipine's role in neuroprotection has established its clinical significance. The expanding understanding of cerebrovascular disorders coupled with innovative formulations are influencing NIMBEX’s market trajectory. This report analyzes the market drivers, competitive landscape, regulatory considerations, and financial potential that shape NIMBEX's future.

Market Overview

Global Neurovascular Disease Market

The global neurovascular disease management market, projected to reach over USD 15 billion by 2028, underpins NIMBEX’s potential. Central to this industry are subarachnoid hemorrhage cases, which represent a significant subset (~5% of strokes). Nimodipine’s proven efficacy in improving outcomes post-SAH sustains demand, positioning NIMBEX as a critical therapeutic agent.

Therapeutic Scope of Nimodipine

Primarily indicated for preventing delayed ischemic neurological deficits caused by vasospasm, nimodipine’s off-label applications include traumatic brain injury and other cerebral ischemic conditions. Additionally, ongoing research into neuroprotective effects may broaden its utility, further expanding the market.

Market Dynamics

Drivers

• Rising Incidence of Stroke and SAH: Increasing prevalence globally, exacerbated by aging populations, elevates demand for effective cerebrovascular treatments. According to the World Health Organization, stroke is a leading cause of mortality, correlating to heightened usage of nimodipine formulations.

• Clinical Efficacy and Standard of Care: Multiple clinical trials support nimodipine’s role in reducing morbidity post-SAH, cementing its status as the standard of care. The American Heart Association (AHA) guidelines recommend nimodipine treatment for aneurysmal SAH, reinforcing steady prescription volumes.

• Innovation in Formulation and Delivery: Efforts to develop sustained-release variants and alternative administration routes are anticipated to improve pharmacokinetics, patient compliance, and expand niche markets.

• Emergence of Biosimilars and Generics: Patent expirations in certain markets could facilitate generic formulations, intensifying competition but enabling broader accessibility.

Challenges

• Regulatory Barriers: Approvals for new formulations or indications necessitate rigorous clinical data, potentially delaying market penetration.

• Competition from Alternative Therapies: Emerging neuroprotective agents and anti-vasospasm drugs could erode nimodipine’s market share.

• Pricing and Reimbursement Policies: Healthcare cost containment measures restrict pricing flexibility, impacting revenue prospects.

Regulatory Landscape

NIMBEX’s regulatory pathway varies across regions. In the U.S., nimodipine received FDA approval decades ago; however, newer formulations or delivery systems require supplementary approvals. The European Medicines Agency (EMA) maintains strict standards, emphasizing pharmacovigilance and clinical efficacy. Regulatory developments in emerging markets, such as China and India, open avenues for localized approval, especially for cost-effective formulations.

Competitive Landscape

Leading players include Pfizer, Novartis, and generic manufacturers introduced post-patent expiry. The entry of biosimilar and generic products has intensified price competition. Innovation efforts by biotech firms aim to differentiate their nimodipine derivatives through extended-release formulations or combination therapies.

Financial Trajectory

Historical Performance

Historically, nimodipine’s global sales have experienced modest growth, driven predominantly by the steady demand in neurovascular care. Pfizer's legacy formulations generated annual revenues exceeding USD 300 million pre-patent expiry.

Projected Growth

Forecasts indicate a compound annual growth rate (CAGR) of approximately 4-6% over the next five years for the nimodipine market segment, driven by the expanding patient base and clinical adoption. For NIMBEX specifically, strategic investments in formulation improvements could result in premium pricing and increased market share.

Revenue Streams

• Prescription Sales: The bulk of revenue derived from hospital and neuro-focused outpatient settings.
• Regulatory Approvals for New Indications: Potential expansion into traumatic brain injury or secondary stroke prevention could serve as growth catalysts.
• Partnerships and Licensing: Collaborations with local pharmaceutical firms in emerging markets could accelerate penetration and revenue.

Cost & Investment Considerations

Clinical trial expenses for new formulations or indications remain significant. However, leveraging existing safety profiles reduces development costs. Regulatory compliance, manufacturing scale-up, and marketing also influence financial outcomes.

Risks

Economic fluctuations, healthcare policy changes, and competitive responses threaten profit margins. Patent expirations could precipitate erosion of market share, especially in mature markets.

Future Outlook

The financial trajectory of NIMBEX hinges on several factors: successful regulatory navigation, innovative formulation development, strategic marketing, and market expansion. The increasing global burden of cerebrovascular disorders aligns favorably with long-term sales potential. Nonetheless, manufacturers must actively address competitive dynamics, cost management, and regulatory challenges to optimize profitability.

Key Takeaways

• The growing prevalence of SAH and stroke underscores sustained demand for nimodipine-based therapies like NIMBEX.
• Established clinical efficacy as a standard treatment, coupled with potential new formulations, provides avenues for revenue growth.
• Patent expirations and generic competition pose risks but also create opportunities for market expansion through cost-effective alternatives.
• Regulatory strategies adapted for specific markets can facilitate faster adoption, especially in emerging economies.
• Investment in innovative delivery systems and new indications could substantially elevate NIMBEX’s revenue trajectory.

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FAQs

1. What is the primary therapeutic use of NIMBEX?
NIMBEX is primarily used to prevent vasospasm in patients with subarachnoid hemorrhage, improving neurological outcomes by reducing the risk of delayed cerebral ischemia.

2. How does NIMBEX differentiate from generic nimodipine formulations?
NIMBEX often features proprietary formulations aimed at enhanced pharmacokinetics, such as sustained-release mechanisms, which may offer improved efficacy and compliance compared to traditional generics.

3. What regulatory hurdles could impact NIMBEX’s expansion?
Approval for new formulations or indications requires extensive clinical trials to demonstrate safety and efficacy. Variability in regulatory standards across countries can also delay market entry.

4. Could biosimilars threaten NIMBEX’s market share?
While biosimilars target biologics, current competition is primarily from generics. However, if new nimodipine formulations are patented, biosimilar-like competition might arise once patents expire.

5. What are the opportunities for growth in emerging markets?
Localized approval processes, lower manufacturing costs, and increasing neurovascular disease awareness make emerging markets attractive for NIMBEX’s expansion, especially through partnerships with regional pharmaceutical firms.

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Sources

[1] World Health Organization. Global stroke factsheet, 2021.
[2] American Heart Association. Guidelines for the management of aneurysmal subarachnoid hemorrhage, 2019.
[3] MarketWatch. Neurovascular disorder therapeutics market forecast, 2022.
[4] FDA. Drug approval database; nimodipine approvals and labels, 2020.
[5] European Medicines Agency. Assessment reports for nimodipine formulations, 2021.