Ibuprofen lysine - Generic Drug Details

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

Ibuprofen lysine is the generic ingredient in two branded drugs marketed by Xgen Pharms and Recordati Rare, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ibuprofen lysine. Three suppliers are listed for this compound.

Summary for ibuprofen lysine

US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	5
Patent Applications:	381
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ibuprofen lysine
What excipients (inactive ingredients) are in ibuprofen lysine?	ibuprofen lysine excipients list
DailyMed Link:	ibuprofen lysine at DailyMed

Recent Clinical Trials for ibuprofen lysine

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

Sponsor	Phase
Oxford Pharmascience Ltd	Phase 1
Reckitt Benckiser Healthcare (UK) Limited	Phase 1
Simbec Research	Phase 1

See all ibuprofen lysine clinical trials

Pharmacology for ibuprofen lysine

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

Anatomical Therapeutic Chemical (ATC) Classes for ibuprofen lysine

B05XB	Amino acids
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for IBUPROFEN LYSINE

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 ibuprofen lysine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xgen Pharms	IBUPROFEN LYSINE	ibuprofen lysine	INJECTABLE;INTRAVENOUS	202402-001	Mar 30, 2016	AP	RX	No	No
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 ibuprofen lysine

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

Ibuprofen lysine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ibuprofen Lysine

Introduction to Ibuprofen Lysine

Ibuprofen lysine, a derivative of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen, is specifically designed for intravenous administration, particularly in neonates to treat patent ductus arteriosus (PDA). Here, we delve into the market dynamics and financial trajectory of this crucial pharmaceutical product.

Market Size and Growth

The global market for ibuprofen lysine is anticipated to experience significant growth over the coming years. According to recent reports, the market is expected to grow at a Compound Annual Growth Rate (CAGR) of roughly a specified percentage over the next five years, reaching a substantial valuation by 2023[1][4].

Regional Market Analysis

North America

North America is a dominant region in the ibuprofen lysine market, driven by a robust healthcare infrastructure and high healthcare expenditure. The region includes the United States, Canada, and Mexico, with the U.S. being a major contributor due to its well-established pharmaceutical industry and strong distribution networks[1][3].

Europe

Europe is another significant market for ibuprofen lysine, with countries like Germany, the UK, France, and Italy playing key roles. The region's market growth is supported by the gradual recovery of production in Western Europe and the presence of major pharmaceutical manufacturers[4].

Asia-Pacific

The Asia-Pacific region, particularly China, is emerging as a major producer and consumer of ibuprofen lysine. China's increasing market share, which has risen from about 26% in 2010 to nearly 45% currently, highlights its growing importance in the global market[4].

Market Segmentation

By Type

The ibuprofen lysine market is segmented into various product types, including vials and pre-filled formulations. These different types cater to different medical needs and preferences, with pre-filled formulations gaining popularity due to their convenience and ease of use[4].

By Application

The primary applications of ibuprofen lysine include hospitals and drug stores. Hospitals are the largest consumers, given the drug's use in treating PDA in neonates. Other applications include outpatient care and specialized medical facilities[1][4].

Financial Trajectory

Revenue and Market Share

The global revenue for ibuprofen lysine is projected to increase significantly over the forecast period. For instance, the market revenue was noted to be a certain amount in 2018 and is expected to reach a higher valuation by 2031, with a CAGR of a specified percentage during 2023-2031[4].

Production and Supply

Global production of ibuprofen lysine is anticipated to increase, driven by recovery in Western Europe and growth in the Asia-Pacific region. China, being the largest producer and consumer, contributes significantly to the global supply chain[4].

Regulatory Environment

The pharmaceutical industry, including the ibuprofen lysine market, operates under stringent regulatory frameworks. Regulatory scrutiny and approval processes can pose challenges, potentially limiting the introduction of innovative products to the market. Compliance with these regulations is crucial for market players to ensure timely product development and market entry[3].

Key Drivers and Challenges

Key Drivers

• Increasing Demand for Pain Management: The growing need for effective pain management, especially in neonates with PDA, drives the demand for ibuprofen lysine.
• Advancements in Drug Delivery Systems: Innovations in drug delivery, such as sustained-release formulations, enhance patient compliance and convenience, contributing to market growth[3].
• Expanding Healthcare Access: Increasing healthcare awareness and access in emerging markets provide significant growth opportunities[3].

Challenges

• Regulatory Scrutiny: Strict regulatory standards and approval processes can delay product launches and impact market growth.
• Competition: The presence of alternative treatments and competitive products in the NSAID market can challenge the growth of ibuprofen lysine[3].

Market Forecast

Global Forecast

The global ibuprofen lysine market is forecasted to grow at a specified CAGR from 2023 to 2031, reaching a substantial revenue by the end of the forecast period. This growth will be driven by increasing demand in hospitals, expanding healthcare access, and advancements in drug delivery systems[1][4].

Regional Forecast

Regional forecasts indicate continued dominance by North America and Europe, with the Asia-Pacific region, particularly China, showing significant growth potential. The market in these regions will be influenced by local healthcare policies, regulatory environments, and the presence of major pharmaceutical companies[1][4].

"China continued to be both the world’s largest producer and consumer of ibuprofen lysine, with nearly 45% of the world’s market share"[4].

Conclusion

The ibuprofen lysine market is poised for significant growth, driven by increasing demand for effective pain management in neonates, advancements in drug delivery systems, and expanding healthcare access in emerging markets. However, the market must navigate regulatory challenges and competitive pressures to achieve its full potential.

Key Takeaways

• Growing Market Size: The global ibuprofen lysine market is expected to grow at a specified CAGR over the next few years.
• Regional Dominance: North America and Europe are current leaders, with the Asia-Pacific region, especially China, emerging as a significant player.
• Product Segmentation: Vials and pre-filled formulations are key product types, with hospitals being the primary application area.
• Regulatory Challenges: Strict regulatory standards and approval processes are significant challenges.
• Innovative Opportunities: Advancements in drug delivery systems and expanding healthcare access in emerging markets offer growth opportunities.

FAQs

What is ibuprofen lysine used for?

Ibuprofen lysine is used primarily to treat patent ductus arteriosus (PDA) in neonates through intravenous administration.

What are the key regions in the ibuprofen lysine market?

The key regions include North America, Europe, and the Asia-Pacific, with China being a significant player.

What are the main product types in the ibuprofen lysine market?

The main product types are vials and pre-filled formulations.

What drives the demand for ibuprofen lysine?

Increasing demand for effective pain management, especially in neonates with PDA, and advancements in drug delivery systems drive the demand.

What are the regulatory challenges in the ibuprofen lysine market?

The market faces regulatory scrutiny and approval processes, which can delay product launches and impact market growth.

Sources

1. Global Info Research: "Global Ibuprofen Lysine Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2024"[1].
2. FDA: "Ibuprofen Lysine Injection - Label"[2].
3. Market.US: "Ibuprofen Market Size, Share, Growth | CAGR Of 7.8%"[3].
4. Report Ocean: "Ibuprofen Lysine Market Transitions: Adapting to Regulatory Changes"[4].