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, Annora Pharma, and Azurity, and is included in eight NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nimodipine has two patent family members in two countries.

There are eight drug master file entries for nimodipine. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for NIMODIPINE

International Patents:	2
US Patents:	6
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	46
Patent Applications:	6,919
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
Xiaolin Chen, MD	Phase 2/Phase 3
Acasti Pharma Inc.	Phase 3
Xiangtan Central Hospital	Phase 3

See all NIMODIPINE clinical trials

Generic filers with tentative approvals for NIMODIPINE

Applicant	Application No.	Strength	Dosage Form
		60MG/10ML	SOLUTION;ORAL
		30MG/5ML	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	203340-002	Apr 8, 2020		RX	Yes	Yes	11,806,338		Y
Sun Pharm Inds Inc	NIMODIPINE	nimodipine	CAPSULE;ORAL	077067-001	Apr 17, 2007		DISCN	No	No
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020		RX	Yes	Yes	8,517,997		Y
Thepharmanetwork Llc	NIMODIPINE	nimodipine	CAPSULE;ORAL	090103-001	Apr 7, 2014	AB	RX	No	No
Bionpharma	NIMODIPINE	nimodipine	CAPSULE;ORAL	076740-001	Jan 17, 2008	AB	RX	No	Yes

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	8,517,997
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988	3,799,934
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	7,070,581
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988	4,406,906
Bayer Pharms	NIMOTOP	nimodipine	CAPSULE;ORAL	018869-001	Dec 28, 1988	3,932,645

International Patents for NIMODIPINE

Country	Patent Number	Title	Estimated Expiration
Australia	2003221794	DISPENSER FOR MEDICAMENTS AND METHOD AND APPARATUS FOR MAKING SAME
World Intellectual Property Organization (WIPO)	03093108

NIMODIPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nimodipine

Overview of the Nimodipine Market

The nimodipine market is experiencing significant growth, driven by several key factors. Nimodipine, a calcium channel blocker, is primarily used to prevent and treat complications associated with subarachnoid hemorrhage (SAH) and other cerebrovascular disorders.

Market Size and Growth Projections

As of 2023, the nimodipine market was valued at USD 100 billion and is projected to reach USD 147.4 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Subarachnoid Hemorrhage

The rising incidence of SAH cases globally is a major driver of the nimodipine market. As healthcare awareness and early detection improve, the demand for effective treatments like nimodipine has increased significantly[2].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, including better diagnostic capabilities and enhanced treatment options, have created a favorable environment for the growth of the nimodipine market. This includes the availability of generic versions of nimodipine, which has expanded market access[2].

Clinical Research and Novel Applications

Ongoing clinical trials exploring new therapeutic applications and improved formulations of nimodipine are enhancing its market appeal. The development of novel drug delivery methods and the focus on enhancing patient care in critical situations are additional factors driving market expansion[1][4].

Market Segments

By Product Type

• Tablets: The tablet segment dominates the nimodipine market due to the convenience and ease of oral administration[2].
• Capsules: Capsules are another significant segment, offering an alternative to tablets.
• Liquid and Extended-Release Formulations: These formulations cater to different patient needs and preferences.
• Intravenous Injections: The injection segment is growing, driven by the need for immediate and precise drug delivery in critical care settings[2].

By Application

• Subarachnoid Hemorrhage: This is the primary application, given nimodipine's efficacy in preventing cerebral vasospasm and improving neurological outcomes.
• Stroke: Nimodipine is also used to treat stroke patients, further expanding its market.
• Migraine and Neuroprotection: Other applications include the treatment of migraines and neuroprotection[1].

By Distribution Channel

• Hospital Pharmacies: Hospital pharmacies hold the largest share in the distribution channel segment, as nimodipine is primarily used in hospital settings[2].

Regional Analysis

The nimodipine market exhibits regional variations influenced by healthcare infrastructure, government regulations, and the prevalence of SAH cases. Currently, North America and Europe dominate the market due to well-established healthcare systems and higher awareness levels among healthcare professionals and patients. The Asia Pacific region is expected to witness significant growth in the coming years, driven by rapidly improving healthcare infrastructure and a large patient pool[2].

Market Restraints

Regulatory Challenges

Stringent regulatory requirements for drug approval and compliance can pose hurdles to market expansion. These regulations may delay product launches and limit market access[2].

Potential Side Effects

Adverse effects such as bradycardia, hypotension, and headache associated with nimodipine use can restrain market growth. Patient compliance issues also play a role in this restraint[4].

Opportunities for Growth

Expanding into Emerging Markets

There is a significant opportunity for market growth by expanding into emerging markets with a high prevalence of SAH cases. Strategic collaborations and partnerships can facilitate this expansion[2][4].

Product Innovation

The development of safer and more efficient nimodipine formulations through ongoing research and development efforts presents lucrative opportunities for market growth. Novel drug delivery methods and improved therapeutic applications are key areas of focus[1][4].

Strategic Collaborations

Collaborations and partnerships among pharmaceutical companies can enhance research and development efforts, leading to the development of more effective drugs and expanded market reach[2].

Financial Trajectory

Cost-Effectiveness

Nimodipine has been shown to be cost-effective in the management of SAH, with an incremental cost-effectiveness ratio of $223 per life year gained. This economic justification supports its widespread use[5].

Revenue Growth

The increasing demand for nimodipine, driven by the growing prevalence of SAH and advancements in healthcare, is expected to drive revenue growth. The market's projected growth to USD 147.4 billion by 2031 underscores the significant financial opportunities in this sector[1].

Key Players and Competitive Landscape

Major players in the nimodipine market include Arbor Pharmaceuticals LLC, Sun Pharmaceutical Industries Ltd., Sofgen Pharmaceuticals, Bayer Vital GmbH, Heritage Pharma Labs Inc., and Bionpharma Inc. These companies are involved in strategic collaborations, research and development, and market expansion efforts to maintain and enhance their market presence[3][4].

SWOT Analysis

Strengths

• Effective in preventing complications of SAH.
• Well-established market presence and availability of generic versions.
• Extensive research and clinical evidence supporting its efficacy[2].

Weaknesses

• Potential side effects associated with nimodipine.
• Stringent regulatory requirements for drug approval.
• Limited awareness among patients and healthcare professionals[2].

Opportunities

• Expanding into emerging markets with a high prevalence of SAH cases.
• Product innovation and the development of safer and more efficient nimodipine formulations.
• Collaborations and partnerships to enhance research and development efforts[2].

Threats

• Intense competition from existing market players.
• Regulatory challenges and compliance issues.
• Potential substitutes or alternative treatment options[2].

Key Takeaways

• The nimodipine market is driven by the increasing prevalence of SAH and advancements in healthcare infrastructure.
• The market is expected to grow significantly, reaching USD 147.4 billion by 2031.
• Key drivers include the effectiveness of nimodipine in preventing cerebral vasospasm and improving neurological outcomes.
• Regulatory challenges and potential side effects are significant restraints.
• Opportunities for growth include expanding into emerging markets and developing innovative formulations.

FAQs

What are the primary applications of nimodipine?

Nimodipine is primarily used to prevent and treat complications associated with subarachnoid hemorrhage (SAH) and to treat stroke patients. It is also used for neuroprotection and in the management of migraines[1].

What are the key drivers of the nimodipine market?

The key drivers include the increasing prevalence of SAH, advancements in healthcare infrastructure, and ongoing clinical research exploring new therapeutic applications and improved formulations[1][2].

What are the major restraints to the nimodipine market?

Major restraints include regulatory challenges, potential side effects associated with nimodipine, and limited awareness among patients and healthcare professionals[2][4].

Which regions dominate the nimodipine market?

Currently, North America and Europe dominate the market due to well-established healthcare systems and higher awareness levels. The Asia Pacific region is expected to witness significant growth in the coming years[2].

What is the projected market size of nimodipine by 2031?

The nimodipine market is projected to reach USD 147.4 billion by 2031, growing at a CAGR of 5% from 2024 to 2031[1].

Sources

1. Market Research Intellect: "Nimodipine Market Size By Product, By Application, By Geography"
2. Mark Wide Research: "Nimodipine Market 2024-2032 | Size, Share, Growth"
3. EIN Presswire: "Nimodipine Market New Business Opportunities and Investment Research Report By 2030"
4. Allied Market Research: "Nimodipine Market Size & Share | Industry Forecast By, (2021-2030)"
5. PubMed: "Cost-effectiveness analysis of nimodipine treatment after subarachnoid hemorrhage"