NYMALIZE Drug Patent Profile

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

Nymalize is a drug marketed by Azurity and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in NYMALIZE is nimodipine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nimodipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nymalize

A generic version of NYMALIZE was approved as nimodipine by HERITAGE on May 2^nd, 2007.

Summary for NYMALIZE

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	1
Patent Applications:	4,083
Drug Prices:	Drug price information for NYMALIZE
What excipients (inactive ingredients) are in NYMALIZE?	NYMALIZE excipients list
DailyMed Link:	NYMALIZE at DailyMed

See drug prices for NYMALIZE

Recent Clinical Trials for NYMALIZE

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

Sponsor	Phase
Johns Hopkins University	Early Phase 1

See all NYMALIZE clinical trials

Pharmacology for NYMALIZE

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

Paragraph IV (Patent) Challenges for NYMALIZE

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 NYMALIZE

NYMALIZE is protected by six US patents.

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
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	AB	RX	Yes	Yes			Y
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	AB	RX	Yes	Yes			Y

Expired US Patents for NYMALIZE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020

International Patents for NYMALIZE

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

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

Market Dynamics and Financial Trajectory for NYMALIZE (Nimodipine Oral Solution)

Introduction

NYMALIZE, a nimodipine oral solution, has recently undergone significant developments that impact its market dynamics and financial trajectory. Here, we will delve into the key aspects of this drug, including its indications, formulation changes, regulatory approvals, and the implications for its market and financial performance.

Indications and Clinical Use

NYMALIZE is indicated for the improvement of neurological outcomes by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms, regardless of their post-ictus neurological condition (Hunt and Hess Grades I-V)[2][4][5].

Formulation and Delivery System

The drug has seen a recent reformulation and a new delivery system. Azurity Pharmaceuticals announced the FDA approval of NYMALIZE in a 30 mg/5 mL prefilled ENFit syringe, which is designed to offer a more secure and reliable drug administration through standardization[2][4].

Old vs. New Formulation

The original NYMALIZE formulation was voluntarily withdrawn from the market due to safety concerns related to potential dosing and prescribing errors when both the old and new formulations were available simultaneously. The new formulation has a different product concentration, excipients, and stability profile compared to the original, which could lead to serious complications if confused[1].

Regulatory Approvals

The FDA has played a crucial role in the development and approval of NYMALIZE. The recent approval of the 30 mg/5 mL prefilled ENFit syringe is a significant milestone, highlighting the regulatory body's focus on patient safety and the reduction of dosing errors[2][4].

Risk Mitigation Plan

Arbor Pharmaceuticals, in agreement with the FDA, implemented a Risk Mitigation Plan to ensure the safe transition from the old to the new formulation. This plan included the discontinuation of the old formulation to prevent marketplace confusion and potential adverse events[1].

Market Acceptance and Patient Safety

Market acceptance of NYMALIZE is heavily influenced by its safety profile and the ease of administration. The new ENFit syringe system is designed to enhance patient safety by reducing the risk of dosing errors, which is a critical factor in gaining trust among healthcare professionals and patients[2][4].

Standardization and Reliability

The use of ENFit syringes standardizes the administration process, making it more reliable and secure. This standardization can lead to higher market acceptance as it addresses a significant concern in healthcare settings—medication errors[2][4].

Financial Trajectory

The financial trajectory of NYMALIZE is influenced by several factors, including regulatory approvals, market acceptance, and competition.

Revenue Potential

With the FDA approval of the new formulation and delivery system, NYMALIZE is poised to capture a significant share of the market for treating SAH. The unique delivery system and the focus on patient safety can drive revenue growth as healthcare providers and patients opt for this formulation over other available treatments[2][4].

Competitive Landscape

The pharmaceutical market is highly competitive, and NYMALIZE faces competition from other treatments for SAH. However, its unique formulation and delivery system, along with the regulatory approvals, position it favorably in the market. Differentiating itself from branded reference drugs and generic therapies will be crucial for its commercial success[3].

Regulatory and Market Risks

Despite the positive developments, there are risks associated with regulatory changes, healthcare reform measures, and reimbursement policies. These factors can impact the commercial success of NYMALIZE and its financial performance[3].

Industry Expert Insights

Richard Blackburn, CEO of Azurity Pharmaceuticals, emphasized the company's commitment to patient safety and innovative drug delivery systems. "Patients are our priority, and our purpose is to bring them new formulations and delivery systems that help them benefit from established medicines," he stated. This commitment underscores the company's strategy to drive market acceptance and revenue growth through innovation and patient-centric approaches[2][4].

Statistics and Clinical Evidence

Clinical trials have shown that nimodipine, the active ingredient in NYMALIZE, significantly improves neurological outcomes in patients with SAH. For instance, in clinical trials of nimodipine oral capsules, 11% of treated patients reported adverse events, with the most common being decreased blood pressure in 4.4% of patients. The bioavailability of the oral solution is comparable to that of the oral capsules, ensuring consistent efficacy[5].

Key Takeaways

• Regulatory Approvals: The FDA approval of the new NYMALIZE formulation and ENFit syringe system is a significant milestone.
• Market Acceptance: The focus on patient safety and the standardization of drug administration are key drivers for market acceptance.
• Financial Trajectory: The unique formulation and delivery system position NYMALIZE for revenue growth, but it must navigate regulatory and market risks.
• Competitive Landscape: Differentiation from other treatments and addressing regulatory and market challenges are crucial for commercial success.

FAQs

Q: What is NYMALIZE indicated for?

A: NYMALIZE is indicated for the improvement of neurological outcomes by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms[2][4][5].

Q: Why was the old NYMALIZE formulation withdrawn from the market?

A: The old NYMALIZE formulation was withdrawn due to safety concerns related to potential dosing and prescribing errors when both the old and new formulations were available simultaneously[1].

Q: What is the new delivery system for NYMALIZE?

A: The new delivery system for NYMALIZE is a 30 mg/5 mL prefilled ENFit syringe, designed to enhance patient safety and standardize drug administration[2][4].

Q: How does the new formulation impact patient safety?

A: The new formulation and ENFit syringe system reduce the risk of dosing errors, making drug administration more secure and reliable[2][4].

Q: What are the potential financial risks for NYMALIZE?

A: The financial risks include regulatory changes, healthcare reform measures, reimbursement policies, and competition from other treatments for SAH[3].

Sources

1. HYMAN, PHELPS & MCNAMARA, P.C. - Attachment 1: Request for FDA Determination on Old NYMALIZE Formulation.
2. AZURITY PHARMACEUTICALS, INC. - FDA Approval of NYMALIZE (Nimodipine) Oral Solution in a 30 mg/5 mL Prefilled ENFit Syringe.
3. Acasti Pharma Inc. - 10-K Filing: Market Acceptance and Commercial Success Factors.
4. US Pharmacist - FDA Approves Nymalize Oral Prefilled-Syringe Solution.
5. FDA - NYMALIZE (Nimodipine) Oral Solution Label.