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:	1
Clinical Trials:	5
Patent Applications:	449
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

Market Dynamics and Financial Trajectory for IBUPROFEN LYSINE

Last updated: July 30, 2025

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Introduction

Ibuprofen Lysine, a formulation of the non-steroidal anti-inflammatory drug (NSAID) ibuprofen with lysine as a bioavailability enhancer, has carved a significant niche within the over-the-counter (OTC) and prescription analgesic market. Its unique formulation aims to facilitate rapid absorption and onset of action, making it suitable for acute pain management. As global markets increasingly demand effective, fast-acting analgesics, the commercial trajectory of Ibuprofen Lysine hinges on evolving consumer preferences, regulatory environments, and competitive forces.

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Market Landscape and Competitive Positioning

The global analgesics market, projected to reach USD 31.9 billion by 2027 with a CAGR of approximately 4.2%, is driven largely by rising prevalence of pain-related conditions, aging populations, and increased healthcare awareness [1]. Within this, NSAIDs comprise a significant share, with ibuprofen constituting roughly 20-25% of OTC analgesic sales [2].

Unique Selling Proposition (USP):
Ibuprofen Lysine's enhanced bioavailability results in faster onset compared to standard ibuprofen formulations. This feature appeals to consumers seeking immediate relief, especially in acute settings. Its positioning as a premium OTC analgesic enables higher pricing strategies; however, it faces competition from traditional ibuprofen tablets, paracetamol, and newer formulations like fast-acting gels and combination products.

Competitive Environment:
Major manufacturers such as Johnson & Johnson, Bayer, and GlaxoSmithKline dominate the ibuprofen market. They utilize extensive marketing and distribution networks, with Ibuprofen Lysine often marketed as a specialty product or prescription adjunct, depending on regional regulations [3]. Nonetheless, the entry of generic brands eager to leverage the fast-acting attribute further intensifies price competition.

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Regulatory and Patent Landscape

Patent protection remains critical for maintaining a market edge. Ibuprofen Lysine formulations developed by companies like Boehringer Ingelheim have held patents that extend exclusivity through formulations and delivery systems. However, many of these patents have expired or invalidated, opening pathways for generic manufacturers.

Regulatory approvals, particularly for OTC status in various jurisdictions, influence market penetration. For instance, in the U.S., the FDA's OTC monograph system regulates ibuprofen formulations, with no specific mention of lysine enhancement—thereby limiting exclusive marketing unless approved as a prescription product [4].

Emerging regulatory scrutiny around NSAID safety profiles—especially cardiovascular and gastrointestinal risks—may influence product positioning and formulary placement, impacting sales trajectories.

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Market Drivers and Constraints

Drivers:

• Rising Pain Prevalence: Chronic conditions, such as arthritis, and acute episodes demand effective NSAID therapies [5].
• Consumer Preference for Fast Relief: The bioavailability advantages of Ibuprofen Lysine resonate with consumers seeking rapid symptom alleviation.
• Expansion in Emerging Markets: Growing healthcare infrastructure and increased OTC purchase capabilities facilitate penetration in regions like Asia-Pacific and Latin America.
• Product Innovations: Combination formulations incorporating Ibuprofen Lysine with other analgesics or anti-inflammatory agents boost appeal.

Constraints:

• Safety Concerns: NSAID-related adverse effects limit long-term use, prompting regulatory caution.
• Pricing and Reimbursement: Higher acquisition costs of Ibuprofen Lysine formulations relative to standard ibuprofen target a niche market segment unless supported by premium pricing strategies.
• Generic Competition: Post-patent expiration, generic versions erode profit margins and market share.

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Financial Trajectory and Revenue Forecasts

Predicting the financial trajectory involves analyzing current sales figures and growth patterns. While specific sales data for Ibuprofen Lysine are proprietary, industry estimates suggest that in mature markets, the segment grows at 2-3% annually, primarily fueled by product innovations and expanding consumer awareness.

Historical Performance:
Historical data from key regions indicates stable growth, with some countries witnessing double-digit increases owing to marketing campaigns emphasizing rapid relief and safety profiles.

Forecasted Trends (2023–2030):

• Short-Term Outlook (1–3 years):
  Optimism surrounds increased adoption in emerging markets due to rising healthcare access. Companies are expected to invest in marketing efforts and new formulations to sustain growth.

• Mid to Long-Term Projection (4–10 years):
  The market may experience plateauing or slight declines due to patent expirations and the proliferation of generic equivalents. However, novel formulations offering improved safety or combination therapies with sustained-release properties could recoup market share.

Revenue Potential:
Based on current trends, top-tier pharmaceutical companies could realize annual revenues ranging from USD 150 million to USD 300 million for Ibuprofen Lysine formulations in global markets. Premium formulations or prescription-only variants tend to generate higher margins but smaller volumes.

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Emerging Market Opportunities

Regions such as Asia-Pacific, Latin America, and Africa offer considerable growth potential. Increasing urbanization, expanding healthcare coverage, and a growing middle class create favorable environments for OTC analgesic sales. Manufacturers that adapt formulations to local preferences and regulatory standards will likely capitalize on these opportunities.

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Key Challenges

Despite its advantageous pharmacokinetics, Ibuprofen Lysine's market success confronts challenges such as:

• Pricing pressures due to escalating competition.
• Perceived safety risks associated with NSAID use.
• Regulatory hurdles in certain jurisdictions delaying market access or influencing labeling.
• Limited consumer awareness outside specialized segments, necessitating sustained marketing investments.

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Conclusion

The market dynamics for Ibuprofen Lysine hinge on rapid absorption advantages, evolving consumer preferences, regulatory landscapes, and competitive pressures. While current financial trajectories project moderate growth supported by innovation and expanding markets, sustainability depends on strategic positioning—particularly distinguishing products through safety profiles and formulation innovations. The long-term profitability will increasingly depend on navigating patent landscapes, regulatory changes, and consumer safety perceptions.

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Key Takeaways

• Market Growth: The global NSAID segment, especially fast-acting formulations like Ibuprofen Lysine, is poised for steady growth driven by demand for rapid pain relief.
• Competitive Edge: Its bioavailability advantage provides differentiation, but patent expiration and generic competition threaten margins.
• Regulatory Impact: Approval pathways and safety considerations significantly influence market access and product positioning.
• Emerging Markets: Growth opportunities are abundant in developing regions, provided companies can adapt to local market dynamics.
• Innovation Necessity: Future success depends on developing novel formulations, expanding indications, and reinforcing safety profiles to sustain revenue growth.

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FAQs

1. How does Ibuprofen Lysine differ from standard ibuprofen formulations?
Ibuprofen Lysine utilizes lysine to enhance solubility and absorption, resulting in faster onset of pain relief compared to traditional ibuprofen tablets.

2. What are the primary markets for Ibuprofen Lysine?
Major markets include North America, Europe, and parts of Asia-Pacific, with potential expansion in Latin America and Africa driven by increasing OTC analgesic demand.

3. How does patent expiration affect the financial outlook of Ibuprofen Lysine?
Patent expirations enable generic manufacturers to introduce lower-priced alternatives, exerting downward pressure on prices and profit margins for branded formulations.

4. Are there safety concerns associated with Ibuprofen Lysine?
As with other NSAIDs, risks include gastrointestinal, cardiovascular, and renal side effects; however, the lysine formulation's faster absorption may influence safety profiles, requiring ongoing pharmacovigilance.

5. What strategies can companies employ to sustain growth in this segment?
Investing in formulation innovation, targeting emerging markets, educating consumers and healthcare providers, and developing combination therapies are key strategies for sustained growth.

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References

[1] Grand View Research, "Analgesics Market Size, Share & Trends Analysis," 2022.
[2] Smithers P., "NSAIDs in the OTC Analgesic Market," Journal of Pharm Market, 2021.
[3] GlobalData, "Pharmaceutical Market Insights," 2022.
[4] U.S. Food & Drug Administration, "OTC Drug Monographs," 2023.
[5] World Health Organization, "Pain Management Data," 2022.