NEOPROFEN Drug Patent Profile

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

Neoprofen is a drug marketed by Recordati Rare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in NEOPROFEN is ibuprofen lysine. There are sixty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Neoprofen

A generic version of NEOPROFEN was approved as ibuprofen lysine by XGEN PHARMS on March 30^th, 2016.

Summary for NEOPROFEN

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	4
Patent Applications:	231
Drug Prices:	Drug price information for NEOPROFEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEOPROFEN
What excipients (inactive ingredients) are in NEOPROFEN?	NEOPROFEN excipients list
DailyMed Link:	NEOPROFEN at DailyMed

See drug prices for NEOPROFEN

Recent Clinical Trials for NEOPROFEN

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

Sponsor	Phase
Food and Drug Administration (FDA)	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2
State University of New York - Downstate Medical Center	Phase 2

See all NEOPROFEN clinical trials

Pharmacology for NEOPROFEN

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for NEOPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEOPROFEN	Injection	ibuprofen lysine	10 mg/mL, 2 mL vials	021903	1	2010-10-01

US Patents and Regulatory Information for NEOPROFEN

NEOPROFEN is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes	8,415,337		Y	Y

Expired US Patents for NEOPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,342,530
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,344,479

International Patents for NEOPROFEN

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

Country	Patent Number	Title	Estimated Expiration
Canada	2377453
Austria	318136
Japan	2002193799	PHARMACEUTICAL COMPOSITION, METHOD OF PREPARING THE SAME AND METHOD OF TREATMENT

Supplementary Protection Certificates for NEOPROFEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

NEOPROFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NEOPROFEN

Introduction

NEOPROFEN, an ibuprofen lysine solution, is a critical medication used to close a clinically significant patent ductus arteriosus (PDA) in premature infants. Understanding the market dynamics and financial trajectory of NEOPROFEN is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Indications and Usage

NEOPROFEN is specifically indicated for the closure of PDA in premature infants weighing between 500 and 1500 grams, who are no more than 32 weeks gestational age. This narrow but critical indication highlights the drug's specialized market niche[4].

Market Niche and Demand

The demand for NEOPROFEN is driven by the need for effective treatments for premature infants with PDA. Given the specific patient population, the market is relatively small but highly specialized. This niche market ensures a consistent demand for the drug, particularly in neonatal intensive care units (NICUs).

Competitive Landscape

The market for PDA closure treatments is not highly competitive, as NEOPROFEN is one of the few approved medications for this specific indication. However, other treatments and surgical interventions may also be considered, which can influence market dynamics. The lack of direct competitors allows NEOPROFEN to maintain a significant market share in its niche[4].

Financial Performance

Revenue Generation

NEOPROFEN is part of the pharmaceutical portfolio of companies like Recordati, which has reported strong financial performance in recent years. For instance, Recordati's revenue grew by 9.1% in 2021 compared to 2020, driven in part by the performance of its Specialty & Primary Care business segment, which includes NEOPROFEN[2].

Segment Contribution

The Rare Disease segment, which includes treatments for conditions like PDA, contributed significantly to Recordati's revenue growth. The robust results from both the legacy metabolic portfolio and the endocrine franchise, along with the resilient performance of the broader Specialty & Primary Care business, indicate a stable financial foundation for NEOPROFEN[2].

Geographical Distribution

Recordati's geographical distribution shows a strong presence in various regions, including Europe, Turkey, Russia, and other countries. This diversified footprint helps in maintaining a steady revenue stream for NEOPROFEN across different markets[2].

Key Financial Metrics

• Revenue: NEOPROFEN contributes to the overall revenue of its parent company. For example, Recordati's total revenue reached €1,580.1 million in 2021, with a significant portion coming from its Specialty & Primary Care segment[2].
• EBITDA: The company's EBITDA margin was 38.1% in 2021, indicating strong profitability. This margin is crucial for sustaining investments in research and development, as well as ensuring the continued supply and quality of NEOPROFEN[2].
• Net Income: Recordati's adjusted net income grew by 3.5% in 2021, reflecting the company's financial stability and ability to invest in its product portfolio, including NEOPROFEN[2].

Strategic Initiatives and Partnerships

Recordati has engaged in several strategic initiatives to support the growth of its products, including NEOPROFEN. For instance, the company finalized a License and Supply Agreement with Tolmar International Ltd to market Eligard® (leuprorelin acetate) in various regions, which demonstrates its commitment to expanding its product reach through partnerships[2].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of NEOPROFEN. Changes in local laws and mandates, as well as the expiration or issuance of new patents, can impact the drug's pricing and market access. For example, the recent updates to warnings and precautions for NEOPROFEN highlight the ongoing regulatory scrutiny and the need for continuous compliance[4].

Future Outlook

The future outlook for NEOPROFEN is positive, given the consistent demand for its specific indication and the strong financial performance of its parent company. Here are some key points:

Continued Investment in R&D

Companies like Recordati continue to invest in research and development, ensuring that products like NEOPROFEN remain safe and effective. This ongoing investment is crucial for maintaining market position and addressing any emerging challenges[2].

Market Expansion

The geographical expansion and strategic partnerships undertaken by Recordati are expected to further enhance the market reach of NEOPROFEN. This expansion can lead to increased revenue and a broader patient base[2].

Regulatory Compliance

Adherence to changing regulatory requirements will remain essential for the continued success of NEOPROFEN. Companies must stay vigilant and adapt to any new regulations or guidelines to ensure uninterrupted market access[4].

Key Takeaways

• Specialized Market Niche: NEOPROFEN serves a critical but specialized market, ensuring consistent demand.
• Strong Financial Performance: The drug contributes to the robust financial metrics of its parent company, such as Recordati.
• Strategic Initiatives: Partnerships and licensing agreements support the growth and market reach of NEOPROFEN.
• Regulatory Compliance: Ongoing regulatory updates and compliance are essential for maintaining market access.
• Future Outlook: The drug's future looks positive due to continued investment in R&D and market expansion.

FAQs

What is NEOPROFEN used for?

NEOPROFEN is used to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 grams, who are no more than 32 weeks gestational age[4].

Who manufactures NEOPROFEN?

NEOPROFEN is part of the pharmaceutical portfolio of companies like Recordati[2].

What are the key financial metrics for NEOPROFEN's parent company?

Recordati's revenue reached €1,580.1 million in 2021, with an EBITDA margin of 38.1% and adjusted net income of €424.6 million[2].

How does the regulatory environment impact NEOPROFEN?

Changes in local laws and mandates, as well as updates to warnings and precautions, can impact the drug's pricing and market access. Continuous regulatory compliance is essential[4].

What is the future outlook for NEOPROFEN?

The future outlook is positive, driven by consistent demand, continued investment in R&D, and market expansion through strategic partnerships[2].

Sources

1. Minnesota Department of Health: Prescription Drug Price Growth Report Data.
2. Recordati: 2021 Annual Report.
3. Futura Medical: Preliminary Results and R&D Summary - Year Ending Dec 2018.
4. DailyMed: NeoProfen - ibuprofen lysine solution.